dothedd
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Post by dothedd on Mar 21, 2014 23:40:03 GMT -5
Novavax: A Biotech Story Set To Double In 2014 Jan. 12, 2014 2:46 PM ET
This article is now exclusive for PRO subscribers. There is a biotech company known as Novavax (NVAX) that is creating vaccines for today's infectious diseases. This company has developed two different technology systems to create vaccines quickly, and efficiently for patients that need treatment immediately. The company is headquartered in Rockville Maryland, and was founded back in 1987. It has taken quite some time for this company to perfect its technology system, but it seems that it may have finally found the right formula to combat these infectious diseases.
Two Distinct Nanoparticle Technologies
Virus-like Particles (VLPs) Recombinant protein micelles Virus-like particles are engineered by the scientists at Novavax far differently than the current vaccines out on the market today.
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dothedd
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NOVAVAX
Mar 25, 2014 20:05:12 GMT -5
Post by dothedd on Mar 25, 2014 20:05:12 GMT -5
GAITHERSBURG, Md., March 10, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the fourth quarter and year ended December 31, 2013 and announced the initiation of a Phase 1/2 clinical trial of its H7N9 avian influenza VLP vaccine candidate with its proprietary Matrix-M adjuvant. The trial is enrolling 610 healthy subjects to evaluate the safety and immunogenicity of this vaccine and adjuvant.
Novavax Business Highlights
2013 Achievements:
Reported data from two RSV F-protein nanoparticle vaccine trials, one in 330 women of childbearing age and the other in 220 elderly subjects, demonstrating strong immunogenicity of the RSV vaccine candidate; Demonstrated in the RSV elderly subject trial that the vaccine could be administered concurrently with a seasonal influenza vaccine to elicit potentially protective levels of antibodies to both vaccine targets; Initiated our H7N9 avian influenza VLP vaccine candidate program in April and published the industry's first H7N9 vaccine human clinical trial data showing highly protective levels of antibodies following vaccination in the December 26th issue of the New England Journal of Medicine; Acquired Novavax AB (previously Isconova AB) and its saponin-based adjuvant Matrix-M to support Novavax' vaccine programs; and Completed a successful $100 million secondary stock offering. 2014 Recent Events:
Extended the contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS BARDA; and Initiated a U.S.-based Phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with Matrix-M, enrolling 610 healthy adult subjects between 18 and 64 years old, under the Company's HHS BARDA contract. 2014 Anticipated Events:
Release of top-line data from the ongoing Phase 2 clinical trial of the RSV F protein nanoparticle vaccine candidate in women of childbearing age in the second quarter of 2014; Release of top-line data from the recently initiated Phase 1/2 clinical trial of the H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second half of 2014; Initiate a Phase 2 clinical trial of our RSV F protein nanoparticle vaccine in pregnant women in the fourth quarter of 2014; and Initiate a Phase 2 clinical trial of our quadrivalent VLP seasonal influenza vaccine in the fourth quarter of 2014. "We made substantial progress in advancing our RSV and influenza vaccine development programs during 2013 and I believe 2014 holds the potential for even greater accomplishments across our entire pipeline," said Stan Erck, president and CEO of Novavax, Inc. "Our rapid response to the emergence of an avian H7N9 influenza strain continues to demonstrate the power and flexibility of our vaccine and adjuvant technologies. This year we plan to report top-line results from our ongoing RSV and influenza studies, initiate our first RSV clinical trial in pregnant women and report top-line results from the first study of our H7N9 avian influenza vaccine candidate with our Matrix-M adjuvant. These will be important milestones for these programs for which I anticipate continued success in 2014."
Financial Results for the Fourth Quarter and Year Ended December 31, 2013
In connection with its acquisition on July 31, 2013, Novavax AB's operations have been included in the company's consolidated results of operations and financial position as of the acquisition date. Novavax reported a net loss of $14.1 million, or $0.07 per share, for the fourth quarter of 2013, compared to a net loss of $8.0 million, or $0.06 per share, for the fourth quarter of 2012. For the full year 2013, the net loss was $52.0 million, or $0.31 per share, compared to a net loss of $28.5 million, or $0.22 per share, for 2012.
Novavax revenue in the fourth quarter of 2013 increased 92% to $8.7 million as compared to $4.6 million for the same period in 2012. The increase in revenue was primarily due to the HHS BARDA amendment relating to H7N9 manufacturing and other activities and the PATH amendment to support the company's Phase 2 clinical trial in women of childbearing age.
Research and development expenses increased 69% to $16.3 million in the fourth quarter of 2013, compared to $9.6 million for the same period in 2012, primarily as a result of increased costs relating to the company's RSV and pandemic (H7N9) influenza clinical trials and higher employee-related costs. General and administrative expenses increased 65% to $4.1 million in the fourth quarter of 2013 as compared to $2.5 million for the same period in 2012, resulting primarily from Novavax AB's expenses and higher professional fees.
As of December 31, 2013, the company had $133.1 million in cash and cash equivalents and investments compared to $50.3 million as of December 31, 2012. Net cash used in operating activities for 2013 was $45.4 million compared to $18.2 million for 2012. The increase in cash usage from the prior year was primarily due to higher research and development spending, including the company's RSV and pandemic (H7N9) influenza clinical trials, as well as increased employee-related costs.
Conference Call
Novavax management will host its quarterly conference call today at 4:30 p.m. EDT. The dial-in number for the conference call is 1 (877) 212-6076 (U.S. or Canada) or 1 (707) 287-9331 (international). A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website.
A replay of the conference call will be available starting at 7:30 p.m. on March 10, 2014 until midnight May 1, 2014. To access the replay by telephone, dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 2459615. The replay will also be available as a webcast and can be found on the "Investor Info"/"Events" on the Novavax website.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
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dothedd
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NOVAVAX
Mar 25, 2014 20:49:03 GMT -5
Post by dothedd on Mar 25, 2014 20:49:03 GMT -5
INSIDERS BUYING March 25, 2014
1. Name and Address of Reporting Person * Erck Stanley C Common Stock 03/25/2014 P 10,000 A (1) $ 4.2698 (2) 84,868 D The reported price is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $4.265 to $4.27, inclusive.
2. Name and Address of Reporting Person * PHILLIPS BARCLAY A Common Stock 03/25/2014 P 5,000 A (1) $ 4.245 (2) 14,868 D The reported price is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $4.22 to $4.27, inclusive.
3. Name and Address of Reporting Person * DOUGLAS RICHARD Common Stock 03/25/2014 P 5,000 A (1) $ 4.245 (2) Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 14,868 D The reported price is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $4.305 to $4.39, inclusive.
4. Name and Address of Reporting Person * DOUGLAS RICHARD Common Stock 03/25/2014 P 50,000 A $ 4.334 (1) Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 250,000 D The reported price is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $4.305 to $4.39, inclusive.
5.Name and Address of Reporting Person * YOUNG JAMES F Common Stock 03/25/2014 P 25,000 A $ 4.4735 (1) Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 425,000 D The reported price is a weighted average price. These shares were purchased in multiple transactions at prices ranging from $4.38 to $4.53, inclusive.
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dothedd
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Post by dothedd on Apr 3, 2014 9:14:08 GMT -5
Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM)
GAITHERSBURG, Md., March 10, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today reported its financial results for the fourth quarter and year ended December 31, 2013 and announced the initiation of a Phase 1/2 clinical trial of its H7N9 avian influenza VLP vaccine candidate with its proprietary Matrix-M adjuvant. The trial is enrolling 610 healthy subjects to evaluate the safety and immunogenicity of this vaccine and adjuvant.
Novavax Business Highlights
2013 Achievements:
Reported data from two RSV F-protein nanoparticle vaccine trials, one in 330 women of childbearing age and the other in 220 elderly subjects, demonstrating strong immunogenicity of the RSV vaccine candidate; Demonstrated in the RSV elderly subject trial that the vaccine could be administered concurrently with a seasonal influenza vaccine to elicit potentially protective levels of antibodies to both vaccine targets; Initiated our H7N9 avian influenza VLP vaccine candidate program in April and published the industry's first H7N9 vaccine human clinical trial data showing highly protective levels of antibodies following vaccination in the December 26th issue of the New England Journal of Medicine; Acquired Novavax AB (previously Isconova AB) and its saponin-based adjuvant Matrix-M to support Novavax' vaccine programs; and Completed a successful $100 million secondary stock offering.
2014 Recent Events:
Extended the contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS BARDA; and Initiated a U.S.-based Phase 1/2 clinical trial of H7N9 avian influenza VLP vaccine candidate with Matrix-M, enrolling 610 healthy adult subjects between 18 and 64 years old, under the Company's HHS BARDA contract.
2014 Anticipated Events:
Release of top-line data from the ongoing Phase 2 clinical trial of the RSV F protein nanoparticle vaccine candidate in women of childbearing age in the second quarter of 2014; Release of top-line data from the recently initiated Phase 1/2 clinical trial of the H7N9 avian influenza VLP vaccine candidate with Matrix-M in the second half of 2014; Initiate a Phase 2 clinical trial of our RSV F protein nanoparticle vaccine in pregnant women in the fourth quarter of 2014; and Initiate a Phase 2 clinical trial of our quadrivalent VLP seasonal influenza vaccine in the fourth quarter of 2014.
"We made substantial progress in advancing our RSV and influenza vaccine development programs during 2013 and I believe 2014 holds the potential for even greater accomplishments across our entire pipeline," said Stan Erck, president and CEO of Novavax, Inc. "Our rapid response to the emergence of an avian H7N9 influenza strain continues to demonstrate the power and flexibility of our vaccine and adjuvant technologies. This year we plan to report top-line results from our ongoing RSV and influenza studies, initiate our first RSV clinical trial in pregnant women and report top-line results from the first study of our H7N9 avian influenza vaccine candidate with our Matrix-M adjuvant. These will be important milestones for these programs for which I anticipate continued success in 2014."
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dothedd
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NOVAVAX
Apr 3, 2014 12:04:11 GMT -5
Post by dothedd on Apr 3, 2014 12:04:11 GMT -5
Global vaccination efforts must better engage parents and caregivers
Posted on March 28, 2014 by Guest Contributor
A young woman carries a tray with bags of ice on her head as she walks down a line of people. Getting vaccinated isn’t always a consumer-friendly process. Here, a vendor sells ice and drinks to people in line for meningitis vaccine. Photo: PATH/Gabe Bienczycki. Guest contributor Andy Seale is director of advocacy and communications for vaccine implementation at PATH. This post originally ran in The Guardian’s Global Development Professionals Network partner zone.
PATH’s Geneva office has a striking view over the busy airport that helps ensure this modest-sized Swiss city maintains its status as a leading hub for international finance, global health, and diplomacy.
Looking out from our meeting rooms onto the well-maintained runway, I can’t help but admire the thinking, planning, and investment that goes into airport systems. Linking air traffic control to flight scheduling, separating passengers from baggage and baggage from cargo, and managing security and safety are just a few of the challenges that must be overcome to make airports work.
Serving the vaccine consumer
In our work to ensure all children in the developing world receive lifesaving vaccines, we often have discussions with our partners and funders about how best to make the systems that support vaccination smarter. Traditionally, that has meant focusing on systems that develop safe and effective vaccines and ensure they reach children who need them.
Yet while we have effectively mobilized around these critical supply and infrastructure needs, there has been little comparable investment in the systems that support the “demand side” of vaccination.
A focus on demand
By “demand side,” I mean strategies and approaches based on the needs of consumers seeking vaccines’ protection for themselves or their children.
These demand-side interventions—such as investing in community health workers, advocacy, communications, community partnerships and mobilization, and outreach—can seem less valuable to budget makers, especially when compared to infrastructure and commodity investments. Yet demand-side investments are critical if we want to ensure that those who stand to benefit from vaccines actually take advantage of them.
If we are serious about addressing inequities in vaccination, we need to support demand-side programming.
It’s not easy to get vaccines
In too many places, families must walk for hours to get vaccines. Once they reach a health facility, there’s no guarantee of vaccination that day. Food, drink, and toilet facilities are often scarce. Health workers may not speak the local language—and even when they do, communication about the timing of follow-up doses may be unclear.
Ensuring a child is fully vaccinated requires time, commitment, and action from a well-informed and determined parent or caregiver. It cannot simply be taken for granted.
A people-centered approach
The GAVI Alliance, a public-private partnership that provides vaccines and vaccine financing to the world’s poorest countries, is now identifying priority areas for its 2016–2020 strategy. Many GAVI Alliance partners and stakeholders, including PATH, have proposed increasing support for demand-side perspectives and programming.
Health programs that promote a people-centered approach to systems have often identified creative solutions to overcome barriers not only in the demand side of operations, but also in supply-side functions. Without the activism of cancer patients and people living with HIV, for example, many medications and diagnostics would have taken much longer to develop.
Strong partnerships—and support
Getting vaccines to children requires strong partnerships—not just between the technical agencies, the donors, and the health services delivering vaccines, but also between these services and the mothers and caregivers of the children for whom the vaccines have been developed.
An airport with a state-of-the-art runway but disoriented and unhappy passengers is not fulfilling its mission. A vaccination system that doesn’t provide protection isn’t either. As the GAVI Alliance strategy discussions begin, let’s ensure that demand-side systems are as strong as supply-side. Novavax Announces Continuation of RSV Vaccine Partnership with PATH 01/13/14
Novavax NCT01290419: A Phase I, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 4 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age)
Novavax NCT01704365: A Phase II Randomized, Observer-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum, in Healthy Women of Child-Bearing Age
Novavax NCT01709019: A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age
Novavax NCT01960686: RSV F Dose-Ranging Study in Women
CONTINUED: www.novavax.com/go.cfm?do=Page.View&pid=2
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dothedd
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NOVAVAX
Apr 8, 2014 15:49:36 GMT -5
Post by dothedd on Apr 8, 2014 15:49:36 GMT -5
Novavax to Present at the 13th Annual Needham Healthcare Conference GlobeNewswire Novavax, Inc. April 2, 2014 4:10 PM
GAITHERSBURG, Md., April 2, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer, will present at the 13th Annual Needham Healthcare Conference on April 9, 2014 at 12:10 pm ET in New York City at the Westin Grand Central Hotel.
A live webcast link for the presentation will be available via the company website at www.novavax.com under Investor Info/Events.
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH, and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
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dothedd
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NOVAVAX
Apr 8, 2014 17:30:00 GMT -5
Post by dothedd on Apr 8, 2014 17:30:00 GMT -5
Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations GlobeNewswire Novavax, Inc. April 7, 2014 12:33 PM
GAITHERSBURG, Md., April 7, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Cynthia N. Oliver, Ph.D. to the position of Senior Vice President, Process Development Operations, effective April 8, 2014. Dr. Oliver will be responsible for all process development activities, with a specific focus on the company's RSV F-protein nanoparticle, seasonal influenza and pandemic influenza vaccine candidates.
Dr. Oliver has been a consultant of Novavax since 2011 where her significant expertise and experiences have helped the Company formulate and execute on critical process development strategies. From 1993 until 2010, Dr. Oliver held a variety of positions, including Vice President, Process Biochemistry and Formulation Sciences at Medimmune, Inc., with responsibilities that included vaccines, proteins, monoclonal antibodies and small molecules, including the commercial products Synagis(R) and FluMist(R). Prior to MedImmune, she had similar responsibilities at Merck Research Laboratories, and spent a number of years working at the National Institutes of Health in the National Heart, Lung and Blood Institute. She earned her doctorate from Johns Hopkins, her masters from University of Massachusetts, and her bachelor's degree from Connecticut College.
"At Novavax, successful process development is critical to the ongoing development of our novel vaccines and it serves as the foundation upon which a consistent, GMP commercial manufacturing process is built. Cindy's extensive experience, industry knowledge and managerial aptitude complement our ongoing efforts to bring our RSV, seasonal influenza and pandemic influenza vaccine candidates to licensure," said Stan Erck, President and CEO of Novavax, Inc. "After working with us as a consultant for three years, I am delighted that Cindy has agreed to join Novavax to lead our process development efforts."
Dr. Oliver remarked, "Novavax' progress and success in Phase 2 clinical trials evidences its commitment to bringing important, and in the case of RSV, industry-leading vaccines to the market. I have been delighted to consult with Novavax to this stage, and am equally delighted to head up our efforts to develop safe, high quality vaccines and state-of-the-art vaccine production. Novavax' approach to developing these and other, earlier-stage preclinical vaccine candidates, has tremendous commercial potential, and I am honored to lead the process development function that supports this exciting technology."
About Novavax
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
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dothedd
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NOVAVAX
Apr 8, 2014 18:15:20 GMT -5
Post by dothedd on Apr 8, 2014 18:15:20 GMT -5
This Biotech Market Could Quadruple -- 3 Stocks To Profit StreetAuthority By StreetAuthority on April 07, 2014
Here's a look at three smaller development-stage vaccine makers that are hoping to hit the big time.
1. Novavax (Nasdaq: NVAX) This vaccine maker is targeting RSV (respiratory syncytial virus), which afflicts roughly 3 million babies and elderly people each year, leading to an estimated 66,000 deaths. Longer term, Novavax is also pursuing vaccines for the herpes, bird flu and even the seasonal flu viruses.
The recent swoon in biotech stocks, which I discussed last week, has taken this stock down with the group. In response, a group of four insiders recently acquired nearly $300,000 in stock at an average price of $4.30 a share.
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dothedd
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Post by dothedd on Apr 9, 2014 4:17:52 GMT -5
TODAY: April 9th 2014
Needham & Company 13th Annual Healthcare Conference.
13th Annual Needham Healthcare Conference New York, NY, The Westin NY Grand Central Hotel April 9, 2014, 12:10 pm ET Presenter: Stanley C. Erck Webcast: wsw.com/webcast/needham65/NVAX/
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dothedd
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NOVAVAX
Apr 9, 2014 10:33:22 GMT -5
Post by dothedd on Apr 9, 2014 10:33:22 GMT -5
"RSV unbeaten for decades. But, NVAX RSV vaccine is practically guaranteed. Although RSV vaccine has been elusive for several decades, the difficulty is not in the virus itself. The RSV is closely related to the flu virus, and should be easily beaten. The problem was in the old approaches used, not the virus itself. The day a company called NVAX came up with a new method, RSV was beaten.
Briefly, the traditional methods of making vaccines consist of "farming" the virus, killing the resulting viruses, and then injecting the dead or weakened viruses in people. Then, the immune system learns how to produce antibodies against the virus. Since the viruses injected were inactivated or attenuated, the immune system can take its time to learn how to fight it. Later on, when the person contracts the real virus, the immune system is already "educated" in how to fight it. It will fight it and kill it before the person gets sick.
What made the RSV unbeatable was because the parts that the immune system needs to fight were simply not targeted by the immune system. Then, the only solution would be to force the immune system to target those parts. You could not do this with traditional technologies because all they could do is to create offsprings of the parent viruses with little difference from the parent virus.
How did NVAX solve the problem? NVAX realized that Synagis worked well against RSV, except that Synagis is incredibly expensive and has too many disadvantages to be used for cases other than very serious cases of newborns. What made Synagis work was the fact that it targets Site II of the fusion protein RSV-F. So, NVAX created a (nanoparticle) protein that mimics RSV-F, except for Site II, which NVAX made it more pronounced. NVAX could do this because their VLP/nanoparticle technology is capable of pruning/grafting RNA/DNA gene sequences in ways unbeatable by none.
To this date, only NVAX figured out how to do this. It was extremely difficult, but NVAX did it. Even if competitors succeeded in doing what NVAX did, they would remain a few years behind NVAX, especially since they cannot use the patented discoveries made by NVAX.
As you can see, the difficulty was in creating a "proper" protein to present to the immune system. Now that NVAX has done that, the RSV virus becomes just as easy/difficult to beat as flu viruses. Remember that in all past RSV clinical studies NVAX RSV vaccine induced the immune system to generate 5-10 times more Synagis-like antibodies than Synagis (5 for unadjuvanted, 10 for adjuvanted).
If you think about the above, you'll realize why the case with the (previously) unbeatable RSV is completely different from the cases of yet unbeatable diseases such as cancer. The risks to NVAX investors pale in comparison to the risks with any other company working on yet-unbeatable diseases.
The results of the upcoming RSV phase IIb and later H7N9 phase I/II are practically guaranteed to be just as OUTSTANDING as the results of previous clinical results."
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dothedd
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NOVAVAX
Apr 17, 2014 10:01:50 GMT -5
Post by dothedd on Apr 17, 2014 10:01:50 GMT -5
NOVAVAX 2013 Novavax to Present at the 25th Annual Piper Jaffray Healthcare Conference 11/26/13New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax’ Vaccine Against H7N9 Avian Flu 11/13/13Novavax Reports Third-Quarter 2013 Financial Results11/07/13Novavax to Report Third Quarter 2013 Financial Results on November 7, 201310/30/13Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate 10/07/13Novavax Offering Closing Press Release09/27/13Novavax to Initiate Seasonal and Pandemic Influenza Trials in Collaboration with BARDA 09/24/13Novavax Prices Public Offering of Common Stock09/24/13Novavax to Host an Analyst and Investor Update Call with Webcast 09/17/13Novavax Highlights Positive Results from Partner’s Clinical Trial of Vaccine using Matrix-M™ 09/13/13ICAAC Presentations Highlight Potential Protective Effects of Novavax’ RSV Vaccine Candidate 09/11/13Novavax to Present at the 2013 Stifel Nicolaus Healthcare Conference 09/05/13Novavax to Present RSV Vaccine Clinical and Preclinical Results at ICAAC 09/03/13Novavax Acquires Isconova; Extended Public Tender Offer Period Closed 08/22/13 Novavax Förvärvar Isconova; Förlängda Acceptperioden I Erbjudandet Stängd 08/22/13Novavax Reports Second-Quarter 2013 Financial Results08/08/13NOVAVAX to Present at the 2013 Wedbush Life Sciences Conference 08/06/13Novavax to Report Second Quarter 2013 Financial Results on August 8, 201308/01/13NOVAVAX FÖRVÄRVAR ISCONOVA; FÖRLÄNGER ACCEPTPERIODEN I ERBJUDANDET FÖR KVARVARANDE AKTIEÄGARE I ISCONOVA 07/31/13 NOVAVAX ACQUIRES ISCONOVA; EXTENDS PUBLIC TENDER OFFER PERIOD FOR REMAINING ISCONOVA SHAREHOLDERS 07/31/13Novavax Publishes Positive Preclinical Efficacy Data Against Influenza A(H7N9) 07/30/13Novavax Initiates First Phase 1 Clinical Trial of its A(H7N9) Influenza Vaccine Candidate 07/08/13Novavax Announces Positive Top-Line Results from Phase 1 Clinical Trial of RSV Vaccine Candidate in Elderly 07/02/13Novavax Appoints Barclay “Buck” Phillips as Senior Vice President and Chief Financial Officer06/24/13Novavax Produces MERS-CoV Vaccine Candidate 06/06/13Novavax Announces Public Offer for all Outstanding Shares of Isconova 06/04/13 NOVAVAX AND ISCONOVA TO COMBINE; NOVAVAX LAUNCHES RECOMMENDED PUBLIC OFFER TO ACQUIRE ISCONOVA 06/04/13NOVAVAX OCH ISCONOVA GÅR SAMMAN; NOVAVAX OFFENTLIGGÖR REKOMMENDERAT OFFENTLIGT UPPKÖPSERBJUDANDE TILL AKTIEÄGARNA I ISCONOVA 06/04/13Novavax H7N9 VLP Influenza Vaccine Enters Animal Testing 05/10/13Novavax Reports First-Quarter 2013 Financial Results05/07/13Novavax to Report First-Quarter 2013 Financial Results on May 7, 201304/26/13Novavax to Present at 12th Annual Needham Healthcare Conference 04/25/13Novavax to Review Recent Findings from Vaccine Programs at World Vaccine Congress and Expo in Washington, DC 04/15/13Novavax Appoints Amy B. Fix Vice President of Regulatory Affairs 04/10/13Novavax Reports Positive Top-Line Results From Phase II Clinical Trial of RSV Vaccine Candidate in Women of Childbearing Age 04/02/13Novavax Reports Progress on RSV Vaccine at the XV International Symposium on Respiratory Viral Infections 03/18/13Novavax to Present at the 25th Annual ROTH Conference 03/13/13Novavax, CPLB and ICGEB Collaboration Honored for Malaria Vaccine Progress at Vaccine World Summit India 2013 03/08/13Novavax Reports Fourth Quarter and Year-End 2012 Financial Results03/01/13Novavax to Report 2012 Fourth-Quarter and Year-End Financial Results on March 1, 201302/22/13NOVAVAX to Present at the 15th Annual Bio CEO & Investor Conference 02/07/13BARDA Continues Novavax’ Influenza Vaccine Programs Following In-Process Review 01/24/13
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dothedd
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Post by dothedd on Apr 17, 2014 10:09:47 GMT -5
Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations 04/07/14 Novavax to Present at the 13th Annual Needham Healthcare Conference 04/02/14 Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results 03/10/14 Novavax Appoints John J. Trizzino as Senior Vice President, Commercial Operations 03/10/14 Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness with HHS-BARDA 02/27/14 Novavax to Report Fourth Quarter and Year-End 2013 Financial Results on March 10, 2014 02/19/14 Novavax Announces Management Promotions to Support Expanded Clinical Activity in 2014 01/13/14 Novavax Announces Continuation of RSV Vaccine Partnership with PATH 01/13/14
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dothedd
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Post by dothedd on Apr 17, 2014 10:13:39 GMT -5
"PARTNERING"
In July 2012, Novavax entered into a collaboration with PATH to develop our RSV (respiratory syncytial virus) vaccine to protect infants through maternal immunization in low-resource countries. Novavax was awarded approximately $2 million by PATH for initial funding under the partnership to partially support a Phase II dose-ranging clinical trial in women of childbearing age planned for the second half of 2012.
Thereafter, Novavax and PATH can elect to continue to collaborate on additional phases to develop the vaccine for maternal immunization in low-resource countries, with PATH potentially funding 50% of Novavax’s external clinical development costs. Novavax will retain global rights to commercialize the product and has made a commitment to make the product affordable and available in low-resource countries.
The goal of immunizing pregnant women is to transmit high levels of maternal RSV antibodies to their offspring through the placenta before birth, providing protection against infection in the early infancy period, when the disease burden is the highest. RSV is the most common cause of childhood respiratory infection globally, with a disease burden of 64 million cases and approximately 160,000 deaths annually. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/asthma for many years after the initial event. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available. Maternal immunization is a widely practiced strategy for protecting infants in a variety of diseases, such as neonatal tetanus. Maternal immunization leads to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a viable strategy to protect young infants from RSV illness.
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential.
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dothedd
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Post by dothedd on Apr 17, 2014 10:36:35 GMT -5
LG LIFE SCIENCES
In February 2011, Novavax announced an agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to LG Life Sciences, Ltd. (LGLS). Under the agreement, LGLS receives an exclusive license to manufacture, develop and commercialize influenza vaccines using Novavax’s recombinant VLP technology in South Korea. LGLS also receives a non-exclusive license to manufacture, develop and commercialize influenza VLP vaccines in certain other countries.
LGLS will be responsible for funding clinical development and licensure of influenza VLP vaccines in South Korea and other countries, and for construction of a new VLP vaccine-manufacturing facility planned at LGLS’s Osong campus in South Korea. Novavax will receive upfront and milestone payments from LGLS in addition to double-digit royalty rate payments from commercial sales. Novavax will provide VLP technology transfer and manufacturing support for LGLS’s new vaccine production facility.
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dothedd
Senior Member
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Post by dothedd on Apr 17, 2014 10:42:30 GMT -5
GE HEALTHCARE
As announced in December 2007, Novavax is partnered with GE Healthcare to co-market a pandemic solution that can quickly scale-up production of influenza VLP vaccines at high yields using fully closed, disposable, and mobile equipment. Such an integrated production approach could address issues of cost and timely supply, both relevant for preparing a global vaccine solution for a pandemic situation. A traditional egg-based inactivated influenza vaccine plant with 50 million doses/annum capacity may cost $150-200 million, take four years to build and commission. Furthermore, the only planned U.S. cell-culture facility with capacity of 100 million doses/annum of seasonal flu vaccine has been projected to cost over $1 billion. By way of comparison, a Novavax VLP vaccine plant capacity of 75 to 100 million doses could be built and commissioned for $35-40 million within 24 months. Importantly, this plant would be able to begin shipping VLP vaccine within 12 weeks ensuring a rapid response during a pandemic. And unlike other traditional vaccine plants, the Novavax facility can support other vaccines beyond pandemic. This creates even greater value and vaccine self-sufficiency for the country and its citizens.
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Apr 17, 2014 10:45:56 GMT -5
Post by dothedd on Apr 17, 2014 10:45:56 GMT -5
CADILA PHARMACEUTICALS In 2009, Novavax formed a joint venture with Cadila Pharmaceuticals Ltd., Ahmedabad, India, to develop, manufacture and market vaccines, pharmaceuticals and diagnostic products in India. This joint venture, called CPL-Biologics or CPLB, is developing a number of Novavax' VLP vaccine candidates, as well as a number of Cadila's therapeutic vaccine candidates for the Indian territory. This strategic alliance allows Novavax to utilize Cadila's world-class research, clinical development, and manufacturing expertise and infrastructure to support development of current and future vaccine candidates. CPLB has constructed a state-of-the-art vaccine facility in Dholka, India that has the capability of producing potentially 60 million doses of novel vaccines every year.
Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the state of Gujarat. Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in India and in over 50 countries around the world. Cadila Pharmaceuticals is an integrated healthcare solutions provider with a pharmaceutical product basket in therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals. The state-of-the-art research and development facility at Cadila Pharmaceuticals is manned by more than three hundred and fifty scientists and engineers from various disciplines including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry and different disciplines of engineering.
Cadila Pharmaceuticals also participates in public-private partnerships for developing preventive and curative pharmaceutical and diagnostic products. Over the last decade Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple investigational new drug applications (INDs) approved by U.S. Food and Drug Administration. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at various locations in India and in Addis Ababa in Ethiopia.
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
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Post by dothedd on Apr 17, 2014 10:49:26 GMT -5
BARDA
Novavax announced in March 2011 that it had been awarded a contract valued at up to $179 million by the Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. During the contract’s 3-year base period, valued at $97 million, Novavax will continue to develop and manufacture its novel, clinical-stage, recombinant virus-like particle (VLP) influenza vaccines to address BARDA’s commitment to advancing recombinant-based technology and pandemic preparedness. The contract could be extended for an additional 24-month option period with $82 million in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration (FDA). During the contract’s base period, funded activities would include:
three (3) clinical trials utilizing Novavax’s pandemic influenza VLP vaccine candidate with adjuvants (including Novavax’s proprietary Novasome adjuvant); Phase II dose-ranging trial and Phase III registration trial utilizing Novavax’s seasonal influenza VLP vaccine candidate; and development of a manufacturing facility plan that has the capability to produce finished vaccine within twelve (12) weeks and at least 50 million doses within six (6) months of an influenza pandemic declaration. Novavax’s manufacturing facility plan will outline the design, construction, commissioning, qualification and validation of such a U.S.-based facility to produce recombinant seasonal and pandemic vaccines. Additional funded base period activities include vaccine product characterization, process development and scale–up of recombinant vaccine manufacturing including consistency lot manufacturing and lot-release assay development in support of the Phase III trial.
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
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Post by dothedd on Apr 17, 2014 10:57:13 GMT -5
LATEST PUBLICATIONS SCIENTIFIC Page 1 Respiratory Syncytial Virus Fusion Glycoprotein Expressed in Insect Cells Form Protein Nanoparticles That Induce Protective Immunity in Cotton Rats. PLOS ONE, Smith, Gale, et al.
Intranasal Vaccination with 1918 Influenza Virus-Like Particles Protects Mice and Ferrets from Lethal 1918 and H5N1 Influenza Virus Challenge. Journal of Virology, Perrone, Lucy A., et al.
Cross-Clade Protective Immune Responses to Influenza Viruses with H5N1 HA and NA Elicited by an Influenza Virus-Like Particle. PLOS ONE, Bright, Rick A., et al.
VACCINES
A Recombinant Viruslike Particle Influenza A (H7N9) Vaccine The New England Journal of Medicine, Fries, Louis, et al.
Rapid Manufacture and Release of a GMP Batch of Avian Influenza A(H7N9) Virus-Like Particle Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology BioProcessing Journal, Hahn, Timothy J. et al. Journal Link
Development of influenza H7N9 virus like particle (VLP) vaccine: Homologous A/Anhui/1/2013 (H7N9) protection and heterologous A/chicken/Jalisco/CPA1/2012 (H7N3) cross-protection in vaccinated mice challenged with H7N9 virus Vaccine, Smith, Gale, et al.
Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine Vaccine, Glenn, Gregory M., et al.
H5N1 Virus-Like Particle Vaccine Elicits Cross-Reactive Neutralizing Antibodies That Preferentially Bind to the Oligomeric Form of Influenza Virus Hemagglutinin in Humans. Journal of Virology Khurana, Surender, et al.
Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico. Vaccine, López-Macías, Constantino, et al.
Influenza virus-like particle can accommodate multiple subtypes of hemagglutinin and protect from multiple influenza types and subtypes. Vaccine, Pushko, Peter, et al.
ADJUVANTS
Immune enhancing properties of the novel Matrix-M™ adjuvant leads to potentiated immune responses to an influenza vaccine in mice. doi: 10.1016/j.vaccine.2013.01.039. [Epub ahead of print] Sofia E. Magnusson, Jenny M. Reimer, Karin H. Karlsson, Lena Lilja, Karin Lövgren Bengtsson, Linda Stertman.
Matrix-M™ Adjuvant Induces Local Recruitment, Activation and Maturation of Central Immune Cells in Absence of Antigen. PLoS ONE 7(7): e41451. doi:10.1371/journal.pone.0041451 Jenny M. Reimer, Karin H. Karlsson, Karin Lövgren-Bengtsson, Sofia E. Magnusson, Alexis Fuentes, Linda Stertman.
High-throughput proteomic screening identifies Chlamydia trachomatis antigens that are capable of eliciting T cell and antibody responses that provide protection against vaginal challenge. Vaccine 30 (2012) 4387-4393 Michele D. Picard, Kenya Prince Cohane, Todd M. Gierahn, Darren E. Higgins, Jessica Baker Flechtner
T-helper 1 cells elicited by H5N1 vaccination predict seroprotection. J Infect Dis. 2012 Jul 15;206(2):158-66. Epub 2012 May 2 Pedersen G.K., Madhun A.S., Breakwell L., Hoschler K., Sjursen H., Pathirana R.D., Goudsmit J., Cox R.J.
Iscom technology-based Matrix M™ adjuvant: success in future vaccines relies on formulation. Vaccines 10(4), 401-403 (2011) Lövgren Bengtsson K, Morein B, Osterhaus ADME.Expert Rev.
A novel guinea pig model of Chlamydia trachomatis genital tract infection. Vaccine 29 (2011) 5994-6001 Marien I. de Jongea, Sander A.S. Keizera, Hicham M. el Moussaouia, Lieke van Dorstena, Rima Azzawia, Hanneke I. van Zuilekoma, Patricia P.W. Petersa, Fred J.H. van Opzeelandc, Laura van Dijka, Rob Nieuwlandb, Henriëtte W.M. Roosenboom-Theunissenb, Mieke P. Vrijenhoekb, Isolde Debyserd, Pierre J.M. Verweije, Wilbert G.F. van Duijnhovene, Johannes F. van den Boscha, Piet J.M. Nuijtena
Intramuscular Matrix-M-adjuvanted virosomal H5N1 vaccine induces high frequencies of multifunctional Th1 CD4+ cells and strong antibody responses in mice. Vaccine, 2009 Dec 9;27(52):7367-76 Madhun AS, Haaheim LR, Nilsen MV, Cox RJ.
Matrix-M adjuvanted virosomal H5N1 vaccine confers protection against lethal viral challenge in a murine model. Influenza Other Respi Viruses. 2011 May 9. doi: 10.1111/j.1750-2659.2011.00256.x. Pedersen G, Major D, Roseby S, Wood J, Madhun AS, Cox RJ.
Antibody and T-cell responses to a virosomal adjuvanted H9N2 avian influenza vaccine: impact of distinct additional adjuvants. Vaccine, 2008 Jul 4;26(29-30):3640-6 Radosevic K, Rodriguez A, Mintardjo R, Tax D, Bengtsson KL, Thompson C, Zambon M, Weverling GJ, Uytdehaag F, Goudsmit J.
Chlamydia muridarum T-cell antigens formulated with the adjuvant DDA/TDB induce immunity against infection that correlates with a high frequency of gamma interferon (IFN-gamma)/tumor necrosis factor alpha and IFN-gamma/interleukin-17 double-positive CD4+ T cells. Infection and Immunity, 2010 May;78(5):2272-82 Yu H, Jiang X, Shen C, Karunakaran KP, Jiang J, Rosin NL, Brunham RC.
Vaccination of horses against strangles using recombinant antigens from Streptococcus equi. Vaccine, 2007 May 4;25(18):3629-35 Waller A, Flock M, Smith K, Robinson C, Mitchell Z, Karlström A, Lannergård J, Bergman R, Guss B, Flock JI.
Duration of immunity induced by an equine influenza and tetanus combination vaccine formulation adjuvanted with ISCOM-Matrix. Vaccine, 2010 Oct 8;28(43):6989-96 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ.
The first safe inactivated equine influenza vaccine formulation adjuvanted with ISCOM-Matrix that closes the immunity gap. Vaccine, 2009 Sep 4;27(40):5530-7 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ.
Nasal immunization with plasmid DNA encoding P6 protein and immunostimulatory complexes elicits nontypable Haemophilus influenzae-specific long-term mucosal immune responses in teh nasopharynx. Vaccine, 2011 Feb 24; 29(10):1881-90 Satoru Kodama, Takashi Hirano, Kenji Noda, Shingo Umemoto, Masashi Suzuki
Vaccination of dogs with six different candidate leishmaniasis vaccines composed of a chimerical recombinant protein containing ribosomal and histone protein epitopes in combination with different adjuvants. Vaccine, 2009 Jul 16; 27(33):4439-46 J. Poot, L.H.M. Janssen, T.J. van Kasteren- Westerneng, K.H.A. van der Hekjden-Liefkens, V.E.J.C. Schijns, A. Heckeroth
Immune response to Neospora caninuim negative antigens formulated with immune stimulating complexes in calves. Vet. Parasitol, 2011 Feb 10;175(3-4):245-51 D.P. Moore, I.Echaide, A.E. Verna, M.R. Leunda, A. Cano, S. Pereyra, P.I. Zamorano, A.C. Odeón, C.M. Campero
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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Post by dothedd on Apr 17, 2014 11:03:01 GMT -5
LATEST PUBLICATIONS SCIENTIFIC Page 2 Respiratory Syncytial Virus Fusion Glycoprotein Expressed in Insect Cells Form Protein Nanoparticles That Induce Protective Immunity in Cotton Rats. PLOS ONE, Smith, Gale, et al.
Intranasal Vaccination with 1918 Influenza Virus-Like Particles Protects Mice and Ferrets from Lethal 1918 and H5N1 Influenza Virus Challenge. Journal of Virology, Perrone, Lucy A., et al.
Cross-Clade Protective Immune Responses to Influenza Viruses with H5N1 HA and NA Elicited by an Influenza Virus-Like Particle. PLOS ONE, Bright, Rick A., et al.
VACCINES
A Recombinant Viruslike Particle Influenza A (H7N9) Vaccine The New England Journal of Medicine, Fries, Louis, et al.
Rapid Manufacture and Release of a GMP Batch of Avian Influenza A(H7N9) Virus-Like Particle Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology BioProcessing Journal, Hahn, Timothy J. et al. Journal Link
Development of influenza H7N9 virus like particle (VLP) vaccine: Homologous A/Anhui/1/2013 (H7N9) protection and heterologous A/chicken/Jalisco/CPA1/2012 (H7N3) cross-protection in vaccinated mice challenged with H7N9 virus Vaccine, Smith, Gale, et al.
Safety and immunogenicity of a Sf9 insect cell-derived respiratory syncytial virus fusion protein nanoparticle vaccine Vaccine, Glenn, Gregory M., et al.
H5N1 Virus-Like Particle Vaccine Elicits Cross-Reactive Neutralizing Antibodies That Preferentially Bind to the Oligomeric Form of Influenza Virus Hemagglutinin in Humans. Journal of Virology Khurana, Surender, et al.
Safety and immunogenicity of a virus-like particle pandemic influenza A (H1N1) 2009 vaccine in a blinded, randomized, placebo-controlled trial of adults in Mexico. Vaccine, López-Macías, Constantino, et al.
Influenza virus-like particle can accommodate multiple subtypes of hemagglutinin and protect from multiple influenza types and subtypes. Vaccine, Pushko, Peter, et al.
ADJUVANTS
Immune enhancing properties of the novel Matrix-M™ adjuvant leads to potentiated immune responses to an influenza vaccine in mice. doi: 10.1016/j.vaccine.2013.01.039. [Epub ahead of print] Sofia E. Magnusson, Jenny M. Reimer, Karin H. Karlsson, Lena Lilja, Karin Lövgren Bengtsson, Linda Stertman.
Matrix-M™ Adjuvant Induces Local Recruitment, Activation and Maturation of Central Immune Cells in Absence of Antigen. PLoS ONE 7(7): e41451. doi:10.1371/journal.pone.0041451 Jenny M. Reimer, Karin H. Karlsson, Karin Lövgren-Bengtsson, Sofia E. Magnusson, Alexis Fuentes, Linda Stertman.
High-throughput proteomic screening identifies Chlamydia trachomatis antigens that are capable of eliciting T cell and antibody responses that provide protection against vaginal challenge. Vaccine 30 (2012) 4387-4393 Michele D. Picard, Kenya Prince Cohane, Todd M. Gierahn, Darren E. Higgins, Jessica Baker Flechtner T-helper 1 cells elicited by H5N1 vaccination predict seroprotection. J Infect Dis. 2012 Jul 15;206(2):158-66. Epub 2012 May 2 Pedersen G.K., Madhun A.S., Breakwell L., Hoschler K., Sjursen H., Pathirana R.D., Goudsmit J., Cox R.J.
Iscom technology-based Matrix M™ adjuvant: success in future vaccines relies on formulation. Vaccines 10(4), 401-403 (2011) Lövgren Bengtsson K, Morein B, Osterhaus ADME.Expert Rev.
A novel guinea pig model of Chlamydia trachomatis genital tract infection. Vaccine 29 (2011) 5994-6001 Marien I. de Jongea, Sander A.S. Keizera, Hicham M. el Moussaouia, Lieke van Dorstena, Rima Azzawia, Hanneke I. van Zuilekoma, Patricia P.W. Petersa, Fred J.H. van Opzeelandc, Laura van Dijka, Rob Nieuwlandb, Henriëtte W.M. Roosenboom-Theunissenb, Mieke P. Vrijenhoekb, Isolde Debyserd, Pierre J.M. Verweije, Wilbert G.F. van Duijnhovene, Johannes F. van den Boscha, Piet J.M. Nuijtena
Intramuscular Matrix-M-adjuvanted virosomal H5N1 vaccine induces high frequencies of multifunctional Th1 CD4+ cells and strong antibody responses in mice. Vaccine, 2009 Dec 9;27(52):7367-76 Madhun AS, Haaheim LR, Nilsen MV, Cox RJ.
Matrix-M adjuvanted virosomal H5N1 vaccine confers protection against lethal viral challenge in a murine model. Influenza Other Respi Viruses. 2011 May 9. doi: 10.1111/j.1750-2659.2011.00256.x. Pedersen G, Major D, Roseby S, Wood J, Madhun AS, Cox RJ.
Antibody and T-cell responses to a virosomal adjuvanted H9N2 avian influenza vaccine: impact of distinct additional adjuvants. Vaccine, 2008 Jul 4;26(29-30):3640-6 Radosevic K, Rodriguez A, Mintardjo R, Tax D, Bengtsson KL, Thompson C, Zambon M, Weverling GJ, Uytdehaag F, Goudsmit J.
Chlamydia muridarum T-cell antigens formulated with the adjuvant DDA/TDB induce immunity against infection that correlates with a high frequency of gamma interferon (IFN-gamma)/tumor necrosis factor alpha and IFN-gamma/interleukin-17 double-positive CD4+ T cells. Infection and Immunity, 2010 May;78(5):2272-82 Yu H, Jiang X, Shen C, Karunakaran KP, Jiang J, Rosin NL, Brunham RC.
Vaccination of horses against strangles using recombinant antigens from Streptococcus equi. Vaccine, 2007 May 4;25(18):3629-35 Waller A, Flock M, Smith K, Robinson C, Mitchell Z, Karlström A, Lannergård J, Bergman R, Guss B, Flock JI.
Duration of immunity induced by an equine influenza and tetanus combination vaccine formulation adjuvanted with ISCOM-Matrix. Vaccine, 2010 Oct 8;28(43):6989-96 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ.
The first safe inactivated equine influenza vaccine formulation adjuvanted with ISCOM-Matrix that closes the immunity gap. Vaccine, 2009 Sep 4;27(40):5530-7 Heldens JG, Pouwels HG, Derks CG, Van de Zande SM, Hoeijmakers MJ.
Nasal immunization with plasmid DNA encoding P6 protein and immunostimulatory complexes elicits nontypable Haemophilus influenzae-specific long-term mucosal immune responses in teh nasopharynx. Vaccine, 2011 Feb 24; 29(10):1881-90 Satoru Kodama, Takashi Hirano, Kenji Noda, Shingo Umemoto, Masashi Suzuki
Vaccination of dogs with six different candidate leishmaniasis vaccines composed of a chimerical recombinant protein containing ribosomal and histone protein epitopes in combination with different adjuvants. Vaccine, 2009 Jul 16; 27(33):4439-46 J. Poot, L.H.M. Janssen, T.J. van Kasteren- Westerneng, K.H.A. van der Hekjden-Liefkens, V.E.J.C. Schijns, A. Heckeroth
Immune response to Neospora caninuim negative antigens formulated with immune stimulating complexes in calves. Vet. Parasitol, 2011 Feb 10;175(3-4):245-51 D.P. Moore, I.Echaide, A.E. Verna, M.R. Leunda, A. Cano, S. Pereyra, P.I. Zamorano, A.C. Odeón, C.M. Campero
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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Post by dothedd on Apr 17, 2014 11:10:54 GMT -5
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Apr 22, 2014 5:31:51 GMT -5
Post by dothedd on Apr 22, 2014 5:31:51 GMT -5
HEADLINES FOR NOVAVAX Novavax: Promising Pipeline And Stable Revenue Add To Upsideat Seeking Alpha (Tue, Apr 8) Monday, April 7, 2014
Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development OperationsGlobeNewswire (Mon, Apr 7)
Today's Dead Cat Bounce Stock: Novavax (NVAX)at TheStreet (Mon, Apr 7) Wednesday, April 2, 2014
Novavax to Present at the 13th Annual Needham Healthcare ConferenceGlobeNewswire (Wed, Apr 2) Monday, March 31, 2014
Insiders And Analysts Like These Speculative Small Cap Stocksat Seeking Alpha (Mon, Mar 31) Friday, March 28, 2014
3 Reasons to Buy Novavax, Inc.at Motley Fool (Fri, Mar 28) Tuesday, March 25, 2014
Novavax CEO buys 10K shares, CFO buys 5K sharesat theflyonthewall.com (Tue, Mar 25) Novavax CEO buys 10K shares, CFO buy 5K sharesat theflyonthewall.com (Tue, Mar 25) Wednesday, March 19, 2014
3 Stocks to Get on Your Watchlistat Motley Fool (Wed, Mar 19) Saturday, March 15, 2014
NOVAVAX INC FinancialsEDGAR Online Financials (Sat, Mar 15) Friday, March 14, 2014
NOVAVAX INC Files SEC form 8-K, Results of Operations and Financial Condition, Financial Statements and ExhibitsEDGAR Online (Fri, Mar 14) Wednesday, March 12, 2014
NOVAVAX INC Files SEC form 8-K, Change in Directors or Principal OfficersEDGAR Online (Wed, Mar 12) NOVAVAX INC Files SEC form 10-K, Annual ReportEDGAR Online (Wed, Mar 12) Tuesday, March 11, 2014
Novavax price target raised to $10 from $4 at Ladenburgat theflyonthewall.com (Tue, Mar 11)
Novavax's CEO Discusses Q4 2013 Results - Earnings Call Transcriptat Seeking Alpha (Tue, Mar 11) Monday, March 10, 2014
Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM)GlobeNewswire (Mon, Mar 10)
Novavax Appoints John J. Trizzino as Senior Vice President, Commercial OperationsGlobeNewswire (Mon, Mar 10)
Q4 2013 Novavax Earnings Release - Time Not SuppliedCCBN (Mon, Mar 10) Thursday, February 27, 2014
NOVAVAX INC Files SEC form 8-K, Entry into a Material Definitive Agreement, Other Events, Financial Statements and ExEDGAR Online (Thu, Feb 27)
Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness With HHS-BARDAGlobeNewswire (Thu, Feb 27)
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dothedd
Senior Member
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NOVAVAX
Apr 28, 2014 19:06:56 GMT -5
Post by dothedd on Apr 28, 2014 19:06:56 GMT -5
Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing Age • Vaccine candidate was well-tolerated with no vaccine-related serious adverse events • Highest immune responses observed with a single dose of vaccine combined with aluminum phosphate adjuvant • Women with the lowest baseline levels of RSV neutralizing antibodies had the largest increases following immunization, consistent with prior data • Palivizumab-like antibodies exceeded levels observed in previous trials • High levels of antibodies developed within 14 days after immunization and persisted over the 91-day observation period • Data permit selection of vaccine formulation and regimen for planned Phase 2 clinical trial in pregnant women
CONTINUED:www.novavax.com/download/releases/NVAX%20M202%20Data%20Announcement%20PR%202014-04-28%20FINAL%20for%20Global%20Newswire.pdf
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dothedd
Senior Member
Joined: Dec 27, 2010 20:43:28 GMT -5
Posts: 2,683
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NOVAVAX
Apr 29, 2014 8:27:47 GMT -5
Post by dothedd on Apr 29, 2014 8:27:47 GMT -5
Novavax Update (4-28-14)
Company Updates Add comments
NVAX – RSV Vaccine Dose Confirmatory Trial Highly Successful – After the close, Novavax announced positive top-line safety and immunogenicity data from its RSV-F protein nanoparticle vaccine candidate in a Phase 2 clinical trial in 720 women of childbearing age. The randomized, blinded, placebo-controlled Phase 2 study was designed to evaluate the immunogenicity and safety of multiple formulations of Novavax’ RSV-F protein nanoparticle vaccine adjuvanted with aluminum phosphate. The primary outcome of the trial was safety and immune response, measured by levels of serum IgG antibody specific for the F protein. Participants received either one or two intramuscular injections featuring two different dose levels of vaccine antigen with a range of doses of aluminum phosphate adjuvant. These top-line data over the 91-day period following first immunization were highly successful for safety and efficacy and support Novavax’ maternal immunization strategy. With four positive studies in more than 1,100 safety subjects, the current trial represents a major step forward and another de-risking event. Reiterate our BUY under 6 and 13 TARGET PRICE.
Highlights of the interim results include the following:
The RSV-F vaccine candidate was well tolerated, with no vaccine-related serious adverse events, at all doses and formulations. The safety profile was consistent with data from prior Phase 1 and 2 studies. Significant increases in RSV-F antibody levels were observed across all doses and formulations, consistent with prior studies. Peak RSV-F antibody levels were observed in the group that received a single dose of vaccine containing 120 µg of antigen with one-third of the aluminum phosphate dose used in prior studies. Clear increases in RSV neutralizing antibodies were also shown across all doses and formulations, and were strongest in women entering the study with the lowest baseline levels, in confirmation of prior studies. Vaccine-induced palivizumab-like antibody levels demonstrated strong concordance with anti-RSV-F antibody responses. A single 120 µg antigen dose generated peak palivizumab-like antibody levels of approximately 400 µg/mL, the highest levels seen in any study. Kinetic analysis of the antibody responses showed rapid increases in antibody levels in all vaccine formulations and dosing regimens. A single 120µg antigen dose generated peak RSV-F and palivizumab-like antibody levels within 14 days of immunization, and high levels of both were sustained through the 91-day observation period. In our view, the consistency across doses/formulations and compared with previous studies is impressive. The NVAX F-protein vaccine delivered improved immunogenicity in a one-dose regimen, likely leading to improved patient convenience, vaccine uptake and compliance, thus decreasing the burden of RSV disease. In addition the single dose should lead to flexibility for administration during pregnancy. The study confirms a previous clinical trial in women of childbearing age from 2013. These data support the first maternal immunization trial, currently projected to begin in Q4:14.
The Company has requested a Type C meeting with the FDA this summer to discuss the entire suite of pre-clinical and clinical data in support of the initiation of studies in pregnant women. A Type C meeting will allow the company to decide on multiple aspects of the next clinical trial(s). Now they appear to have the appropriate dose/formulation for registration trials – it will be interesting to note if the FDA allows a randomized trial designed for Phase II, but possibly with a crossover to a Phase III study. The impressive results reported today, in our view, makes us believe the path to market could be accelerated. Novavax expects to present the entire date-set at an appropriate scientific forum in the future.
While the most important trials are still ahead of them (e.g., in pregnant women to observe placental transfer of protection, combination trials with the NVAX quadrivalent flu vaccine), today’s results could not be any better. The path to NVAX developing a truly disruptive “respiratory vaccine” has just taken a major step forward.
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dothedd
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NOVAVAX
Apr 30, 2014 10:28:02 GMT -5
Post by dothedd on Apr 30, 2014 10:28:02 GMT -5
New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
University of Maryland School of Medicine Study Published in Vaccine Highlights First Potential Effective Means for Preventing MERS Coronavirus Outbreak
BALTIMORE and GAITHERSBURG, Md., April 30, 2014 (GLOBE NEWSWIRE) -- The University of Maryland School of Medicine (UM SOM) and Novavax, Inc. (Nasdaq:NVAX) today announced that an investigational vaccine candidate developed by Novavax against the recently emerged Middle East Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory studies. UM SOM and Novavax also reported that a vaccine candidate against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) developed by Novavax on a similar platform also inhibited virus infection. Researchers reported these findings in an article published in the April 13, 2014 issue of Vaccine1.
Historically, vaccine strategies for emerging pathogens have been limited due to the sudden nature in which the virus first appears and delayed by the protracted traditional vaccine development process. This peer-reviewed manuscript describes a novel method to rapidly develop vaccines against previously unknown viruses, such as MERS-CoV, which appear suddenly and cause severe illnesses in humans. The experimental vaccines, which were tested in conjunction with Novavax' proprietary adjuvant Matrix-M™, induced neutralizing antibodies, or immune responses, that prevent viruses from infecting cells.
"Our protein nanoparticle vaccine technology is proving to have the potential to respond rapidly to emerging viruses such as MERS-CoV and certain potential pandemic influenza strains, addressing what are clearly urgent public health needs," said Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax. "Novavax will continue to evaluate this technology to produce highly immunogenic nanoparticles for coronavirus, influenza, and other human disease pathogens with the potential for pandemic and sustained human to human transmission."
"The emergence of SARS-CoV and MERS-CoV demonstrates how coronaviruses can spillover from animals into humans at any time, causing lethal disease," said Matthew B. Frieman, Ph.D., Assistant Professor of Microbiology and Immunology at the University of Maryland School of Medicine and corresponding author on the publication. "Despite efforts to create a vaccine against SARS-CoV, no vaccine candidate has, to date, been successfully licensed for use. We have demonstrated that this novel method rapidly creates SARS-CoV and MERS-CoV vaccines that induce neutralizing antibodies in mice."
"The University of Maryland School of Medicine investigators are continually working toward a better understanding of the interactions between the human immune system and a variety of known and novel harmful microbes," said E. Albert Reece, Vice President of Medical Affairs, the University of Maryland and the John Z. and Akiko Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "This makes our faculty poised to respond to emerging infectious diseases, such as MERS-CoV, which threaten the health and wellbeing of the global population."
The vaccine candidates were made using Novavax' recombinant nanoparticle vaccine technology and based on the major surface spike (S) protein, a SARS-CoV and MERS-CoV surface protein responsible for attaching the virus to cells. Novavax previously demonstrated that spike protein nanoparticles could protect animals against lethal live challenge using the SARS-CoV virus2.
About MERS-CoV
MERS-CoV, first identified in 2012, is one of a family of viruses with the potential to rapidly spread from a benign infection of animals to cause severe disease in humans. In 2003, a previously unknown coronavirus called SARS-CoV caused an outbreak that raised health alarms by infecting over 8,000 individuals and killing 775. According to the World Health Organization, the novel MERS-CoV thus far has resulted in 107 deaths out of 345 infections, the majority of which are characterized by severe illness and hospitalizations. Both diseases were marked by a jump from animals to people and while SARS-CoV spread more quickly in humans, MERS-CoV is proving to be more deadly.
About University of Maryland School of Medicine
Established in 1807, the University of Maryland School of Medicine was the first public medical school in the United States, and the first to institute a residency-training program. The School of Medicine was the founding school of the University of Maryland and today is an integral part of the 11-campus University System of Maryland. On the University of Maryland's Baltimore campus, the School of Medicine serves as the anchor for a large academic health center which aims to provide the best medical education, conduct the most innovative biomedical research and provide the best patient care and community service to Maryland and beyond. www.medschool.umaryland.edu.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
About Vaccine
Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society, The International Society for Vaccines and The Japanese Society for Vaccinology. www.elsevier.com/locate/vaccine
References:
1. C. M. Coleman et al. Purified coronavirus Spike protein nanoparticles induce coronavirus neutralizing antibodies in mice. Vaccine. In press, April 13, 2014.
2. Y. Liu et al. Chimeric severe acute respiratory syndrome coronavirus (SARS-CoV) S glycoprotein and influenza matrix 1 efficiently form virus-like particles (VLPs) that protect mice against challenge with SARS-CoV, 2011; 29(38): 6606-6613.
www.novavax.com/download/releases/MERS%20Vaccine%20pr%20042914%20-%20FINAL%20201404301.pdf
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dothedd
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NOVAVAX
May 1, 2014 13:35:11 GMT -5
Post by dothedd on May 1, 2014 13:35:11 GMT -5
Mers vaccine helps mice fight off deadly virus
May 1, 2014
Today, there is no real treatment or vaccine that can tackle Middle East Respiratory Syndrome (Mers), a virus that was first detected in 2012 and has already affected 339 people in Saudi Arabia, killing 102. It's not known how it is transmitted in people, and there is only some evidence to suggest camels might be the most likely animal reservoir responsible for the strain.
Now, a team from the University of Maryland and biopharmaceutical company Novavax says its vaccine candidate has successfully induced neutralising antibodies that effectively block the virus from infecting cells in mice.
Vaccine development is typically very slow, and two papers were only just published identifying a few natural human antibodies that could serve as a basis for new vaccine models targeting Mers. However, Novavax has developed a technique it believes has the potential to be the undoing -- if pursued -- of coronaviruses likes Mers and Sars. They achieve this by building a vaccine containing nanoparticles that mimic the virus structure.
"Both Sars-Cov and Mers-Cov contain a major surface spike protein," Gale Smith, vice president of vaccine development, told Wired.co.uk. In a coronavirus, these S proteins spark the production of neutralising antibodies in the body and also help the virus bind to target cells. If we could induce those antibodies prior to infection, we could theoretically create protection from the coronavirus.
Novovax discovered not only how to replicate the coronavirus structure using nanoparticles (with a larger head and long stem) but the spike protei itself. "We could produce this in their native structure -- we can do that," said Smith. "Viruses are nanoparticles, and with out recombinant nanoparticles we can mimic the virus." Recombination refers to the molecular cloning done in the lab to create genetic sequences. Novavax had already trialled the same method with Sars -- experiments that have been backed up with more than $1m in funding from the US National Institutes of Health -- creating a vaccine based on the specific native spike protein.
The company used the same approach this time around, a process of creating virus-like particles based on a cell line culture originally derived from a type of butterfly called lepidopteran. This process is based on baculovirus expression technology, whereby a nonessential gene is replaced with a foreign gene encoded with certain proteins. For Mers, the spike protein in question should in theory have the epitopes (the protein markers that induce immune system responses) neccessary to block the interaction between the Mers virus and human cells, says Smith.
"We use them in a bioreactor to produce proteins like those in Sars or influenza," says Smith, "these are all full length and form these nanostructures that are proven to be highly immunogenic. This tech was demoed last March with influenza, and by June we tested the resulting vaccine in humans. It's a very rapid response for emerging diseases, and now that same technology is becoming proven for Mers, another emerging pathogen that threatens potentially all of us."
The next step would be to see if animal models -- possibly camels in the case of Mers -- can be effectively immunised, with the vaccine candidate producing the right neutralising antibodies to block the virus persistently over time in a sustained way. But Smith explains the group is unlikely to take the research forward unless cases of sustained human to human transference begin.
"For us to proceed further would depend on the perceived need -- there's clearly a need for animal vaccines though. It's a powerful demonstration though, that this is the first practical approach for a vaccine that could be produced commercially using a proven technology for this disease. The strength of what we have is a rapid response for emerging pathogens."
Saudi Arabia is, however, known to be speaking with industry players about the potential development of a vaccine.
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dothedd
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NOVAVAX
May 1, 2014 19:14:34 GMT -5
Post by dothedd on May 1, 2014 19:14:34 GMT -5
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dothedd
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NOVAVAX
May 5, 2014 15:56:37 GMT -5
Post by dothedd on May 5, 2014 15:56:37 GMT -5
Press Releases relative to the Day's PPS and Volume Thursday, May 1, 2014 4.35 4.43 4.23 4.33 3,475,600 4.33 Novavax to Report First Quarter Financial Results on May 7, 2014GlobeNewswire( (Thu, May 1) Wednesday, April 30, 2014 4.51 4.53 4.3 4.38 4,835,400 4.38 New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV)GlobeNewswire( (Wed, Apr 30) Monday, April 28, 2014 3.93 4.01 3.7 3.94 3,436,200 3.94 Novavax Announces Positive Top-Line Data from Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate in Women of Childbearing AgeGlobeNewswire( (Mon, Apr 28) Monday, April 7, 2014 4.03 4.26 3.89 4.1 5,230,300 4.10 Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development OperationsGlobeNewswire( (Mon, Apr 7) Wednesday, April 2, 2014 4.52 4.55 4.3 4.39 2,728,800 4.30 Novavax to Present at the 13th Annual Needham Healthcare ConferenceGlobeNewswire( (Wed, Apr 2) Monday, March 10, 2014 6 6.01 5.66 5.86 4,328,800 5.86 Novavax Reports Fourth-Quarter and Year-End 2013 Financial Results and Initiation of Phase 1/2 Clinical Trial of Its H7N9 Avian Influenza VLP Vaccine Candidate With Matrix-M(TM)GlobeNewswire( (Mon, Mar 10) Novavax Appoints John J. Trizzino as Senior Vice President, Commercial OperationsGlobeNewswire (Mon, Mar 10) Thursday, February 27, 2014 6.17 6.92 6.17 6.65 7,511,900 6.65 Novavax Announces Extension of Contract for Advanced Development of Recombinant Influenza Products and Pandemic Preparedness With HHS-BARDAGlobeNewswire (Thu, Feb 27) Wednesday, February 19, 2014 1 5.78 5.86 5.65 5.71 2,281,700 5.71 Novavax to Report Fourth Quarter and Year-End 2013 Financial Results on March 10, 2014GlobeNewswire (Wed, Feb 19) Thursday, September 12, 2013 3.36 3.41 3.12 3.34 4,620,100 3.34
Genocea Reports Positive Initial Phase 1/2a Results for GEN-003, its Pioneering Therapeutic Vaccine Candidate for the Treatment of Herpes Simplex Virus-2 (HSV-2), at ICAAC 2013PR Newswire (Thu, Sep 12) Wednesday, August 28, 2013 3.00 3.08 2.97 3.02 2,316,900 3.02 Genocea Biosciences Selected To Present Late-Breaking Oral Presentation At ICAAC 2013PR Newswire( (Wed, Aug 28) Monday, July 8, 2013 2.69 2.72 2.56 2.58 4,057,200 2.58 GenScript's Rush Gene Services Help Novavax Expedite 28-day Development of H7N9 VaccineCNW Group(Mon, Jul 8) GenScript's Rush Gene Services Help Novavax Expedite 28-day Development of H7N9 VaccinePR Newswire( (Mon, Jul 8) Monday July 8, 2013 2.69 2.72 2.56 2.58 4,057,200 2.58
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dothedd
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NOVAVAX
May 5, 2014 16:25:04 GMT -5
Post by dothedd on May 5, 2014 16:25:04 GMT -5
Saudi Arabia MERS cases surpass 400, more than 100 dead, 4 pm today 5/5/14
Some 414 people in Saudi Arabia have fallen victim to the deadly Middle East Respiratory Syndrome (MERS) virus after a further 18 were diagnosed on Monday. One hundred and fifteen people have died so far as a result of the disease.
All of the new cases diagnosed in the past 48 hours were concentrated around the country’s capital, Riyadh, along with Jeddah – the main gateway to the Islamic holy city of Mecca, in the country’s west – and both holy cities of Mecca and Medina, according to the Saudi Health Ministry, which reported the cases on its website.
The disease is beginning to pose a severe concern to Saudi Arabia, which will host millions of foreign Muslim pilgrims during Ramadan in July. Millions more are expected in October for the Hajj pigrimage to Mecca. The journey must be completed at least once in every Muslim's lifetime, and is one of the 'Five Pillars' of the faith.
“From mid-March 2014, 111 people have tested positive in the Jeddah area; the biggest single surge in the MERS-CoV outbreak since the new virus was detected in April 2012. Thirty-one persons have died,” the World Health Organization (WHO) said in a statement released Friday.
Some 115 people have now died from the SARS-like virus, according to the health ministry. A large proportion of the deaths have been foreign health workers.
A further case was reported on Monday in Jordan. The man in question is reportedly related to someone previously diagnosed with MERS, according to Reuters.
Qatar, Kuwait, the United Arab Emirates, and Tunisia have been among other countries which have documented cases within their borders. Greece has also reported that one of its citizens – a permanent resident of Saudi Arabia – contracted the virus, and last week the US confirmed the case of a man who had recently been to Saudi Arabia.
On Monday, Egypt said it was looking into the possibility of whether a 60-year-old woman had died of MERS.
MERS has spread since it was initially discovered in Saudi Arabia two years ago; incidences have doubled since the beginning of April alone.
MERS has frequently been compared to the Severe Acute Respiratory Syndrome (SARS) virus which swept through Asia in 2003, infecting over 8,000 people and causing some 800 deaths worldwide. MERS is thought to be deadlier but more difficult to transmit. There is no vaccine or treatment for MERS at present.
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dothedd
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NOVAVAX
May 5, 2014 17:19:13 GMT -5
Post by dothedd on May 5, 2014 17:19:13 GMT -5
Novavax's VP of R& ... Says Production of MERS Vaccine is Analagous to Situation Described in NEJM Paper on H7n9 By Charles Gross May 4, 2014 9:43 AM Benzinga
Dr. Gregory Glenn, Novavax's (NASDAQ: NVAX) VP of R& ... told Benzinga in an email Saturday, that the production of a MERS (Middle East Respiratory Syndrome) vaccine was an analogous situation to that mentioned in the paper on H7n9, published in the New England Journal of Medicine. The paper, published on December 12, 2013, describes a trial of 284 adults in a "randomized, observer-blinded, placebo-controlled clinical trial" of a H7n9 vaccine. The paper states that the vaccines studied in the trial were released for human use within 3 months after the availability of HA (hemagglutinins) and NA (neuraminidase) sequences.
On Friday, the CDC held a news conference to discuss the first known U.S. case of MERS. The patient, a health case worker, fell ill following a trip to Saudi Arabia. On Saturday, the Indiana Department of Health reported the patient was still at the Community Hospital in Munster, Indiana and his condition was improving.
The MERS virus was first reported in Saudi Arabia in 2012. Most people with MERS develop severe acute respiratory illness, including fever, cough, and shortness of breath. The mortality rate is about 30%, according to the CDC.
Novavax shares closed unchanged Friday at $4.33.
Novavax, Inc. 4.35+0.02(0.46%) NasdaqGS 4:00 PM EDT 5.5.14
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dothedd
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NOVAVAX
May 6, 2014 14:33:20 GMT -5
Post by dothedd on May 6, 2014 14:33:20 GMT -5
Novavax Produces MERS-CoV Vaccine Candidate
ROCKVILLE, Md., June 6, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced today that it had successfully produced a vaccine candidate designed to provide protection against the recently emerging Middle East Respiratory Syndrome Coronavirus (MERS-CoV). The vaccine candidate, which was made using Novavax' recombinant nanoparticle vaccine technology, is based on the major surface spike (S) protein. The Company believes that its MERS-CoV vaccine candidate may provide a path forward for a vaccine for this emerging threat.
MERS-CoV is a novel coronavirus first identified in September 2012 by an Egyptian virologist, who isolated the previously unknown coronavirus from the lungs of a 60-year-old patient with pneumonia and renal failure. To date, the World Health Organization (WHO) has reported a total of 53 laboratory-confirmed cases of infection with MERS-CoV, including 30 deaths. The newly emergent virus is a part of the coronavirus family that includes the severe acute respiratory syndrome coronavirus (SARS-CoV), first recognized as a global threat in March 2003 and by July 2003, had resulted in 8,098 SARS cases in 26 countries, with 774 deaths.
Novavax had previously produced a recombinant nanoparticle vaccine candidate for the SARS-CoV virus which was similarly based on its major surface S protein. Novavax' SARS-CoV vaccine candidate study demonstrated immunogenicity and complete protection of animals in a live viral challenge; the study was published in the journal Vaccine (online 14 July, 2011).
MERS-CoV was first reported in Saudi Arabia and has spread to Europe, including England, France, Germany and most recently Italy. Health officials do not know how the newly discovered MERS-CoV spreads, making the development of an effective vaccine an important public health priority.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platform to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these organizations support Novavax' worldwide commercialization strategy and have the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
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