NOVAVAX

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Novavax Initiates First Phase 1 Clinical Trial of Its A(H7N9) Influenza Vaccine Candidate


ROCKVILLE, Md., July 8, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a Phase 1 clinical trial of its monovalent virus-like particle (VLP) vaccine candidate for the prevention of disease due to A/Anhui/1/13-like A(H7N9) avian influenza viruses (A(H7N9) vaccine).

This Phase 1, randomized, observer-blinded, placebo-controlled trial will enroll up to 280 eligible adults. Each subject will be randomized into one of seven treatment groups, including placebo, or varying doses of the A(H7N9) vaccine, with or without an adjuvant. Each subject will receive two identical intramuscular doses at Day 0 and Day 21 and undergo study follow-up for approximately one year after the second dose. All subjects will be evaluated for safety and immunogenicity.

"Novavax has moved our program rapidly from the A/Anhui/1/13-like (H7N9) viral gene sequence, to vaccine candidate, into multiple animal studies, and now, exactly three months after the gene sequence was obtained, into a clinical trial," said Stan Erck, President and Chief Executive Officer of Novavax. "We expect to report top-line results from this clinical trial later this year. This level of performance is a testament to the Novavax technology and the hard-work and commitment of its people. It serves as a powerful example of the Company's ability to respond rapidly to any future pandemic event."

About A(H7N9) Influenza

In March 2013, avian-origin A(H7N9) viruses emerged as human pathogens in Southeastern China. As of 4 July 2013, 133 human cases had been reported to the WHO from China, including 43 deaths. The majority of these patients were hospitalized with severe pneumonia, acute respiratory distress syndrome and multi-organ dysfunction. Immunologic experience with these A(H7N9) viruses had not been observed previously in the general population. In the event these viruses gain the ability for efficient and sustained human-to-human transmission, an influenza pandemic could result, with the potential for high rates of illness and mortality worldwide. Although it appears that the first A(H7N9) epidemic has subsided, the presence of a natural reservoir, the lack of antibodies to A(H7N9) in the general population, the severity of the disease and the potential for a second wave epidemic suggest an urgent need for A(H7N9) vaccine development. Vaccines are widely considered to be the first line of defense for protecting populations in advance of an influenza pandemic.

About VLPs and Novavax' Vaccine Program

VLPs are self-assembling protein structures that resemble the external structure of viruses, and when used as antigen in a vaccine, elicit broad and strong antibody and cellular immune responses, but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major virus proteins that are important targets for fighting influenza: hemagglutinin stimulates the body to produce antibodies that prevent binding of the influenza virus; neuraminadase induces immunity that prevents viral spread through the cells in the respiratory tract; and matrix 1 stimulates cytotoxic T lymphocytes to kill infected cells. VLPs have been and can be designed quickly to match novel viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant protein nanoparticle vaccine 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 platforms 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.


CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000

 
Source: Novavax, Inc.

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Clinical Trials


•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 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 NCT01596725: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 2

•Novavax NCT01594320: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1

•Novavax NCT01561768: A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-64) Adults

•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 NCT01014806: Phase IIa trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like-particle (VLP) vaccine (recombinant) in older adults

•Novavax NCT01072799: Phase II trial to assess the safety and immunogenicity of an A (H1N1) 2009 Influenza virus-like particle (VLP) Vaccine

•Novavax NCT00903552: Phase IIa randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults

•Novavax NCT00754455: A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults

•Novavax NCT00519389: Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

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Press Release: GenScript USA Inc. – Mon, Jul 8, 2013 9:00 AM

PISCATAWAY, N.J., July 8, 2013 /PRNewswire/ -- GenScript, the world's largest provider of synthetic genes, has aided a leading biopharmaceutical company, Novavax, Inc. (NVAX), in developing an avian influenza A/H7N9 vaccine candidate, by synthesizing three constructs containing genes that encode for key vaccine proteins in just 6 business days. On May 10, 2013, Novavax announced that its vaccine candidate was developed and entered into pre-clinical trials in only 28 days, less than 6 weeks after initial reports of H7N9 infections on April 1.

The manufacture of the constructs used in Novavax's H7N9 vaccine candidate was powered by GenScript's Rush Gene Service, which synthesizes gene sequences in as few as 4 days. GenScript also offers free gene sequence optimization, which is advantageous for the production of vaccines and protein-based biologics. Normally, it takes researchers using traditional laboratory methods two weeks or more to assemble constructs like those used to produce an H7N9 vaccine. However, as demonstrated by the rapid development of Novavax' vaccine candidate, the combination of gene optimization, rush gene synthesis and custom cloning, facilitated by GenScript's one-stop service platform, can drastically reduce assembly time, accelerating research and development.

"Our mission is to save lives by helping scientists accelerate their research. In this case, our Rush Gene Services are the perfect example of our commitment to our mission," said GenScript CEO Frank Zhang, Ph.D. "The progress made by scientists at Novavax on its H7N9 vaccine candidate in such a short time is the reason why we are dedicated to providing high-quality services on a daily basis."

About GenScript

Founded in 2002, GenScript is a leading biology CRO specializing in customized biology research services including gene and peptide synthesis, protein expression, antibody generation and drug discovery/development. GenScript is headquartered in Piscataway, NJ, has subsidiaries in Europe, Japan, and China, and has over 1,300 employees, who are dedicated to providing biology research services to 86 countries worldwide. Learn more at www.genscript.com.

About Novavax

Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company creating vaccines to address a broad range of infectious diseases worldwide. Using innovative recombinant nanoparticle technology, and efficient manufacturing approaches, Novavax produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and respond to rapidly spreading infections. Learn more at www.novavax.com.

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Novavax Publishes Positive Preclinical Efficacy Data Against Influenza A(H7N9)

Positive efficacy data from its A(H7N9) vaccine published in the peer-reviewed scientific journal Vaccine
Novavax vaccine-induced immunity provided 100% protection against lethal wild-type A(H7N9) influenza challenge versus 0% survival in control (H5N1) vaccine and placebo groups.

Achieved complete cross-protection with its H7N3 VLP vaccine against H7N9 challenge
Animal model efficacy data supports clinical development of an H7N9 VLP vaccine

ROCKVILLE, Md., July 29, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive preclinical data for the company's virus-like particle (VLP) vaccine candidate against A(H7N9) influenza. The data were published online in the peer reviewed journal Vaccine.

The study examined the immunogenicity and efficacy of two doses of its A(H7N9) VLP vaccine candidate against a lethal wild-type challenge mouse model. Three control groups included Novavax' non-homologous A(H7N3) VLP vaccine candidate, its A(H5N1) VLP vaccine candidate, and a placebo. All vaccine candidates were administered with or without Iscomatrix®, a saponin-based adjuvant.

Highlights of the published article:

*A(H7N9) VLP vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of ≥1:64 against H7N9 in all animals (n=8) at the lowest dose tested of unadjuvanted vaccine (0.7 micrograms)
*A(H7N9) VLP vaccine candidate demonstrated cross-reactive HAI against H7N3, with 3- to 4-fold higher HAI responses when used with adjuvant
*A(H7N9) VLP vaccine elicited anti-neuraminidase (NA) antibodies against H7N9 , with 3- to 4-fold higher responses in corresponding adjuvanted subgroups
*100% survival of all animals receiving H7N9 and H7N3 VLP vaccine candidates against a lethal murine wild type *A/Anhui/1/2013 (H7N9) challenge, versus 0% survival in the H5N1 vaccine candidate and placebo receiving groups.

"On May 10, 2013, only 28 days after the recent A/Anhui/1/13-like H7N9 strain was sequenced, the Novavax team announced it had immunized animals with VLPs produced by our platform technology. Just weeks after initiation of this experiment, the resulting animal data demonstrates complete protection of by our A(H7N9) and A(H7N3) VLP vaccine candidates in a lethal live H7N9 virus challenge. Additionally, the study showed complete cross-protection when the VLP vaccine was not a perfect match for the challenge virus. We believe the combined rapid manufacture, animal efficacy data and evidence of cross-protection substantiate the potential of the Novavax vaccine technology as applied to emerging pandemic strains. These animal data add to our confidence that the vaccine candidate will elicit protective immune responses in humans," said Dr. Gregory Glenn, Novavax' Chief Medical Officer. "The publication of this data in a high quality peer reviewed journal such as Vaccine reflects recognition of the quality and importance of this study."

"Alongside our positive clinical results with our H5N1 VLP vaccine candidate from last October, these recently gathered animal data against A(H7N9) influenza give further confirmation that the Novavax vaccine platform deserves to play a key role in emerging pandemic threats," added Stanley C. Erck, President and Chief Executive Officer. "We remain focused on expanding this campaign, as evidenced by the start of the first H7N9 vaccine clinical trial, which we announced on July 8."

The paper was authored by a team of experienced researchers and clinicians, including Novavax' Dr. Gale Smith, Vice President, Vaccine Development, Dr. Gregory Glenn, Senior Vice President and Chief Medical Office, and Dr. Louis Fries, Vice President, Clinical and Medical Affairs. The paper represents the first peer-reviewed publication of positive immunogenicity data for an A(H7N9) vaccine candidate. The paper is available at www.sciencedirect.com/science/article/pii/S0264410X13009870.

About VLPs and Novavax' Vaccine Program

VLPs are self-assembling protein structures that resemble the external structure of viruses, elicit broad and strong antibody and cellular immune responses but lack the live genetic material that causes viral replication and infection. VLPs contain three of the major structural virus proteins that are important for fighting influenza: hemagglutinin and neuraminidase, both of which stimulate the body to produce antibodies that neutralize the influenza virus and prevent its spread through the cells in the respiratory tract, and matrix 1, which stimulates cytotoxic T lymphocytes to kill cells that may already be infected. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable recombinant cell-culture technology. Novavax' VLP-based vaccine candidates are produced more rapidly than egg-based vaccines because of our cell-culture technology platform combined with single-use bioprocessing technology employed strategically throughout the manufacturing process.

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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5 Surprise Stocks the Pros Love Right Now

08/01/13 - 01:28 PM EDT


5 Stocks Under $10 Set to Soar
08/01/13 - 01:30 PM EDT

Stock quotes in this article: IDRA, NVAX, TTPH, AVL, SYNC, CBMX

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Trend Analysis <[e-mail]>

NOVAVAX (NASDAQ:NVAX) Strong Uptrend Up Arrow Smart Scan Chart Analysis confirms that a strong uptrend is in place and that the market remains positive longer term. Strong Uptrend with money management stops. A triangle indicates the presence of a very strong trend that is being driven by strong forces and insiders.
Based on a pre-defined weighted trend formula for chart analysis, NVAX scored +100 on a scale from -100 (strong downtrend) to +100 (strong uptrend):


+10 Last Hour Close Above 5 Hour Moving Average
+15 New 3 Day High on Monday
+20 Last Price Above 20 Day Moving Average
+25 New 3 Week High, July 1st
+30 New 3 Month High on July 31

+100 Total Score 

 
 
 
 
 

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5 Stocks Under $10 Set to Soar

BY Roberto Pedone | 08/01/13 - 01:30 PM EDT

Stock quotes in this article: IDRA, NVAX, TTPH, AVL, SYNC, CBMX

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Upcoming Events

Novavax Second Quarter 2013 Financial Results
Rockville, Maryland
August 8, 2013, 8:30 am ET
Replay dial-in: 1-855-859-2056 (domestic) or 1-404-537-3406 (international),
Conference ID: 26944315
Webcast: click here

CEO - Stanley C. Erck
www.novavax.com/go.cfm?do=Page.View&pid=149

CLINICAL PIPELINE
www.novavax.com/go.cfm?do=Page.View&pid=13

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BARDA Surge Capacity Estimation
Part of the BARDA contract is surge capacity requirement below:

- 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.

So Novavax has no problems with producing a finished vaccine within 12 weeks, as they have demonstrated that making they can make a vaccine in a few weeks in H7N9 recently.

The second part of making 50 million doses within 6 months, now that is something that NVAX had not the capability to do. That is why they needed to upscale to 1000L tanks. By my calculations, they need two 1000L tanks, and get peak cell density in 5 -6 days. I estimated that good yield would mean 1 million doses per 1000L tank run. So if they need to reach 50 million doses per the BARDA contract, and if it takes them 6 days in the bioreactor and another 2 days to finish the vaccine...then it will be 8 days per 1 million doses. If you have 2 reactors, then basically you can 2 million doses per 8 days or 1 million dose per 4 days. 6 months is about 180 days, and 180/4=45 million doses. So it is in the right ball park, and their optimization effort will hopefully get it just under 8 minutes and we'll be meeting the numbers.

This is what it is all about. Optimization to shift the time required to hit peak cell growth down as much as possible on the 1000L tanks. Hit that number, and collect the milestone paycheck. Lock down the process, and go on with the clinical trials. And definitely make some lemonade. Yippee!

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It was just announced yesterday that the US government will begin tweaking H7N9 to make it more dangerous in order to be prepared for possible pandemic mutations.

- NVAX has recently had 100% success rate in vaccinating animals against H7N9.
- The head of BARDA, Robin Robinson was formerly with NVAX and helped pioneer NVAX VLP tech.
- H7N9 person to person in the news.
- The CDC has noted NVAX and their H7N9 vaccine.
- NVAX is meeting with BARDA Today...

Draw your own conclusions.

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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

by Timothy J. Hahn, PhD, Denise Courbron, Mervyn Hamer, Malek Masoud, James Wong, Konnie Taylor, Jody Hatch, Mike Sowers, Erica Shane, PhD, Margret Nathan, Hua Jiang, PhD, Ziping Wei, PhD, John Higgins, Kwan-Ho Roh, John Burd, Diana Chinchilla-Olszar, PhD, Monique Malou-Williams, Daniel P. Baskind, and Gale E. Smith, PhD
Volume 12, Issue 2 (Summer 2013)

Novavax reported that, in 28 days following public release of the avian influenza A/Anhui/1/2013 (H7N9) virus gene sequences, its recombinant DNA and baculovirus-Spodoptera frugiperda cell culture-based technology was used to produce a virus-like particle vaccine to avian influenza A(H7N9) virus, and murine animal challenge studies were initiated. This report describes Novavax’s manufacturing process and the coordinated timing of critical activities necessary to produce and release a clinical batch of avian influenza A(H7N9) virus virus-like particle vaccine, under current good manufacturing practices, within three months from the time that the virus genomic sequences for this potential pandemic influenza virus were reported...

Citation:
Hahn TJ 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. BioProcess J, 2013; 12(2): 4-17. dx.doi.org/10.12665/J122.Hahn.

Posted online July 29, 2013.
www.bioprocessingjournal.com/index.php/article-downloads/527-j122-rapid-manufacture-and-release-of-a-gmp-batch-of-avian-influenza-ah7n9-virus-like-particle-vaccine-made-using-recombinant-baculovirus-sf9-insect-cell-culture-technology

    

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NOVAVAX ... COOL CHART ....

www.tradingview.com/x/gcLuYLlk/

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The Explosive Biotech Calendar Catalyst Play: Novavax's 1st Analyst Day

Aug 13 2013, 18:42 by: Michael Webb  |  about: NVAX (Novavax, Inc.)

Disclosure: I am long NVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

When Stanley Erck, President and Chief Executive Officer of Novavax Inc., summed up the accomplishments of his team in the second quarter of this year on August 8th, he threw an unturned card on the table in addition to his losing pair of deuces.

Novavax (NVAX) will have its first Analyst's Meeting since the rebirth of the company as a vaccine maker in the year 2005 on September 24th of this year. No one knows what that wild card might be. The mystery makes it the single biggest catalyst in the history of this stock and perhaps the biggest biotech run-up event in the waning months of summer. in Erck's own words...

And so finally, and mark your calendars, September 24 Analyst Meeting will be held. We expect to cover some important activities, including clinical development plans for our RSV maternal program, clinical development plans for RSV elderly and the possibilities for a combination respiratory vaccine, we'll talk about the timing of our RSV pediatric program, our seasonal flu program and our pandemic flu program under BARDA. Hopefully, we'll have some additional insights into the timing of the rabies Phase I trial and finally, we'll update you on any new emerging virus product development activities.

All quotations contained in this article, including those that follow, can be found here in the Q2 2013 Earnings Call Transcript.

The president wasted no time and missed not a single opportunity to hammer home the significance of this date. Here he is wrapping up the presentation before Q&A.

Thanks, Buck. Thanks, everyone, for your participation. My last pitch for our September 24 Analyst Call, put it on your calendars, and we'll provide more details about the event over the next few weeks. We hope you'll be able to join us then as well.

Later, during the Q&A session, he referred to it as an "annual event" to be held each year in New York city. Why the sudden need for such a high profile meeting with the chosen few in Wall Street's lair?

Possibility #1: Erck Needed a Diversion From a Lousy Pair of Twos

It's entirely possible that the whole event is nothing more than a formality concocted as a ruse to divert attention away from a troubling financial report that divulged a pair of gnarly statistics. Losses doubled to $12.6M and revenues declined by half to $3.5M.

Perhaps the worst news of all to blur with a clever dose of fanfare was the redo of the pandemic phase 1 trial with the new Matrix-M adjuvant acquired in the all-stock acquisition of Isconova now complete.

Pity there isn't a potent enough vaccine available for depressed shareholders who began the trading day up 5% pre-market and ended the day down 9% post-Erck. Consequently, Novavax stock has been taking on water and is now listing ever so slightly to the down side.

Possibility #2: Erck Has Good News Regarding Material Changes To The Company But Wanted Them To Be Heard

Telling your girlfriend about your terrific vision for a future together ought not to take place on the day you get demoted from your job and are now earning half of last years salary. She'll probably fixate on the loss and won't really hear anything else you say.

So a separate venue on a different day makes sense. I'm sure that falling from his lips these material facts will be more impactful than they are streaming from my keyboard but here they are anyway.

Novavax now has the most powerful adjuvant in the world to marry with the most powerful antigens.
Novavax is now a hybrid developmental and commercial stage biotechnology company selling animal vaccines and vaccine adjuvant for both human and animal formulations.

Novavax is now a European company which will allow it to sell vaccines without incurring onerous import duties and restrictions in that area of the world.

Stanley C Erck is now Isconova Chairman of the Board where he is joined by fellow Novavax Executive James F Young.
Novavax set the speed record for vaccine production in H7N9 from sequence construct to human vaccination in only 91 days.

static.cdn-seekingalpha.com/uploads/2013/8/13/4021161-1376379657675721-Michael-Webb_origin.png 

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SEEKING ALPHA ARTICLE Continued...

Possibility #3: The Biggest News Event In Company History Needs The Biggest Stage To Equal Its Magnitude

When this meeting is called to order on September 24th it will have the biggest audience as well. While there were five analysts present at the Q2 conference call there will be many more on Analyst Day and likely the best that each represented firm has to offer.

Consequently, this is my favorite motivational scenario. And though there may be more than a single storyline that could lift the stock higher, there's only one that could raise it above its 52-week peak in a single trading day.

Fast Track Status For RSV

Whether I'm right or wrong about this there's no disputing that September 24th places Novavax on a transaxial plane within its own history as a company. Whatever is discussed requires a separate stage to distinguish it from the routine of quarterly reports.

It was clear that the five analysts on hand to cover the Q2 presentation were told in advance what they could and could not talk about in lieu of this date. One of the topics notably off the table of discussion was fast track status for Novavax RSV-F vaccine.

Here is William Tanner of Lazard Capital Markets carefully beating his way around the proverbial bush:


I had one on RSV, Stan, and I don't know -- I don't want to ask you to jump the gun for your September Analyst Meeting but...


Good call William! You're the artful dodger. William's question had to do with the sustainability of immunogenicity in infants after the passing of such from the mother to the child through the placenta. This had already been asked and answered on previous conference calls.

There were in fact numerous RSV related questions all of them carefully, if not painfully worded. As a result, one was left to wonder why the most important inquiry was left unmade.

The market potential of Novavax's RSV-F vaccine was discussed in my last article, Is Novavax On The Fast Track To Profits? With nearly 300 thousand hospitalizations of infant and elderly persons costing over $2.5B annually and no prophylaxis currently available, RSV-F is a market winner in three important ways.

It qualifies for fast track status according the definition provided by the FDA.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.


2. It will have the market all to itself as there are no competing products presently approved or even on the horizon.

3. The best commercial comparison, Pfizer's Prevnar 13 which is marketed to the same infant and elderly populations pulled in $3.7B in 2012 annual revenues.

Though RSV-F profits wouldn't begin accruing until 2016 at the earliest, today's market cap of $354M would be a woeful memory to sideline dwellers. A fair market-cap in anticipation of that eventuality would likely be twice that number or more.

An announcement of this magnitude in New York city on September 24th would almost certainly propel the stock to market day double digit gains. No investor or trader would want to miss out on that kind of action.

Analyst Day Has Made Novavax A Very Interesting Catalyst Play

September 24th now functions in a very similar manner to a trial completion date on the FDA calendar. Novavax has always been a fairly predictable trading vehicle and this date lends a little more predictability to the equation.

For instance, it was to be expected that the stock would retreat 10 or more percentage points after the disappointing earnings call. What's been mildly surprising is the sooner than expected leveling from the decline. Furthermore, while I might expect more erosion under normal circumstances, we don't have normality now.

To the contrary, we have word from the president that more details regarding the Analyst Call will be forthcoming over the next several weeks. Should any of those relate to or hint at RSV fast track, all bets for a gradual rise in the price are off.

A Lesser Possibility Worthy of Muted Celebration

When Edward Tenthoff of Piper Jaffray scored the investigational point of the night by eliciting a confession from Erck that inclusion of the Matrix-M in Novavax' H5N1 candidate would require a redo of phase 1 you could feel the disappointment.

Erck's response, however, included a notable quirk that caught my attention. See if you can pick it up.


And so what we have to do is incorporate it (Matrix-M) into our plans for our vaccine trials. The first one will be with our pandemic flu program and it will require that we do a new equivalent of the Phase I study with Matrix-M to demonstrate that it does what we think it's going to do. Does it hold up anything? It means that the -- it holds it up in the respect that we won't be going directly into a Phase II program on pandemic but because of the marriage of the pandemic and seasonal clinical development plans and the timeline for getting the approval for all of our flu programs, I don't think it will have any impact on the final licensure of our seasonal and pandemic flu program.


The fact is, pandemic and seasonal influenza programs have never been married to the same time line. The latter has always been one step ahead of the former as indicated in the graphic below.

CONTINUED:

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SEEKING ALPHA ARTICLE Continued...

seekingalpha.com/article/1633202-the-explosive-biotech-calendar-catalyst-play-novavaxs-1st-analyst-day 

Now take a look at Isconova's pipeline of vaccine candidates and note that Matrix-M has already passed phase one in avian and seasonal programs.

With four clinical phase 1 trials already on the books it's entirely possible that the FDA through Barda has given sanction to advancement directly into phase III for both flu programs upon successful completion of a single phase I reboot of the pandemic influenza trial. That would be good news indeed.

In Conclusion

I've had a hand on the pulse of this company for the past eight months or so. In the aftermath of my first article former CFO Fred Driscoll invited me to meet with Stan and tour the Novavax facilities. Though honored, I had to decline.

The point is, I've learned a bit about Stanley Erck through listening to him present on six separate occasions. He's a simple and decent man who has a hard time concealing his enthusiasm. If I've read him wrong which is entirely possible, then his pair of deuces wins this hand on a wild card bluff.

If on the other hand I've read him right, then I'll back that pair of deuces and profit a few thousand more.

Source: The Explosive Biotech Calendar Catalyst Play: Novavax's 1st Analyst Day
Additional disclosure: The purpose of my article is to provide information the accuracy of which is as good as the public sources it was derived from. If providing my opinions on matters related to any investment has entertained you then I have accomplished my only goal. Do not act on anything I have written. Rather, do your own due diligence and consult an investment professional before making any investment decision. Acting on what any one writer, including me has imparted to you is foolish at best. I have no better access to resources or gift of opinion formulation than you do. Do not act on anything I have written without doing your own research. There are a myriad of things which can happen in lieu of any forward looking statement I have made. Any stock featured in an article I compose is subject to all manner of influences which can change its value in dramatic fashion upwards or downwards. Invest at your own risk and attain the reward your efforts have wrought.

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SEC
Filing Detail

Form S-8 - Securities to be offered to employees in employee benefit plans 

Filing Date

2013-08-13

Accepted

2013-08-13 17:02:00

Documents

8

www.sec.gov/Archives/edgar/data/1000694/000114420413045258/0001144204-13-045258-index.htm 

[dothedd]

FACTS: from Mike Webb's SA article...

Novavax now has the most powerful adjuvant in the world to marry with the most powerful antigens.

Novavax is now a hybrid developmental and commercial stage biotechnology company selling animal vaccines and vaccine adjuvant for both human and animal formulations.

Novavax is now a European company which will allow it to sell vaccines without incurring onerous import duties and restrictions in that area of the world.

Stanley C Erck is now Isconova Chairman of the Board where he is joined by fellow Novavax Executive James F Young.

Novavax set the speed record for vaccine production in H7N9 from sequence construct to human vaccination in only 91 days.

He also mentioned possible RSV Fast Track, and double digit share price on that news alone.

Sept. 24... Tick Tick Tick...

[dothedd]

Prev Close: $2.51
Open: N/A
Bid: 2.93 x 500
Ask: 2.98 x 600
1y Target Est: $4.42
8/15/13

Aug. 15 at 8:34 AM
NVAX Finally the analysts are waking up!











Sept. 24... Tick Tick Tick...

[dothedd]

Wedbush 2013 Life Sciences Conference
New York, NY, Le Parker Meridien
August 14, 2013, 10:55 am ET
Presenter: Stanley C. Erck
Webcast: click here
wsw.com/webcast/wedbush25/nvax/

wsw.com/webcast/wedbush25/nvax/3__Slide1.jpg  
 
wsw.com/webcast/wedbush25/nvax/3__Slide6.jpg

wsw.com/webcast/wedbush25/nvax/3__Slide10.jpg
 

[dothedd]

Novavax: Big Pharma Wants RSV Bad
Aug 18 2013, 07:40
In my last article on Novavax Inc. (NVAX), I pointed readers toward a coming catalyst in the stock that didn't present itself on the FDA calendar but rather on Novavax's own schedule: the 1st Annual Analyst Day to be held September 24, 2013.

While I had hoped this might be a presentation fast tracking Novavax's RSV-F vaccine, their Wedbush presentation on August 14 ruled out that possibility - at least in two of the three population groups - RSV in the elderly remains a fast-track possibility. Then came Lazard.

On August 15th, Lazard Capital Markets through analyst William Tanner who was quoted in my article reiterated their buy position and raised the target price to $11 from $4.

Question: What caused their reappraisal of Novavax's worth? Answer: Their reassessment of the value of Novavax RSV-F vaccine.

In Lazard's own words through the aforementioned William Tanner:

Novavax RSV-F vaccine is potentially one of the most under appreciated assets in the industry.

While that may be true for industry leaders and the larger investing public outside of Seeking Alpha, it hasn't been true for readers here who have been apprised of the enormous potential value of this asset in several stories including my last two iterations providing RSV insights.

Big pharma has been trying for years to perfect an RSV vaccine but with no success. You can see some of the big names who have thrown up their hands in frustration including Novartis and Merck from the graphic below provided by Novavax' partner, PATH.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766531509687326-Michael-Webb_origin.png

Suffice it to say that RSV-F enters a field of preventative care all to itself with a comparator in Pfizer's Prevnar 13 that rakes in a cool $3.7B a year. Though RSV-F is several years away from commercialization its Phase 1 & 2 trial results thus far have been outstanding.

Some other items you may or may not be aware of with respect to Novavax' RSV-F are as follows.

RSV-F vaccine creates Palivizumab equivalent antibodies in host individuals. Palivizumab is the active antigen in Medimmune's Synagis a $1B per year RSV drug used predominantly in premature infants whose exposure to RSV is extremely life threatening.
Novavax staff is increasingly composed of former Medimmune personnel including its former president of 20 years - James Young.
Here is President and CEO Stanley Erck speaking at the Wedbush Conference this past Wednesday.

"I think we have really benefited from what Medimmune did in measuring the amount of antibody that's required."

"So I'm the CEO. I brought on as chairman Jim Young who's the founder of Medimmune, was president of Medimmune for twenty years, R& for twenty years - and we have probably a third of our company is ex-Medimmune people. So, we have a lot of depth in the company in terms of RSV knowledge."

The Phase 2a trial now completed in women of childbearing age revealed Palivizumab equivalent antibodies that were 10x what Medimmune determined to be immunogenic at both dose levels, with or without adjuvant.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766489024976258-Michael-Webb_origin.png 

The following is a calendar of upcoming RSV-F events drawn from a slide presented at the Wedbush conference referenced above.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766501009229486-Michael-Webb_origin.png

As you can see, RSV-F development will contribute to a host of events that will catalyze the stock over the coming several months. That said, we don't necessarily see the explosive event I referred to in my last article.

So, am I willing to throw in the towel on rapid appreciation in advance of September 24th? Hardly! Since my article was published after market close on August 13th, we've already seen the stock climb 13.9%. Lazard's endorsement alone raised in 7.57% in a single day.

As I established in that article, September 24th is a unique event in the history of the company since its reformulation as a vaccine maker in 2005. The day could be a mere formality but the stage suggests it isn't. The inaugural incidence of an annual occurrence rarely is - think weddings and the like. It was William Tanner himself of Lazard Capital Markets that didn't want to "jump the gun" on just what was to be revealed on this special day.

As a result, I'm led to believe there's a surprise coming on September 24th and it will contribute to the value of this company and growth of this stock. In the interim, we'll be left to speculate on just what that might be.

Be aware that fast track status for RSV in the elderly remains a distinct possibility, albeit not a strong one. Novavax' Quadrivalent seasonal flu vaccine has passed Phase II with efficacy in all four strains. It was noticeably absent from the discussion of being modified with the new Matrix-M adjuvant acquired from Isconova that will be applied to the pandemic mixture.

This is important because Novavax established in its Phase 1 trial in RSV in the elderly that its RSV-F vaccine had no deleterious effect on the performance of an established flu vaccine and has since indicated it will market both together in one formulation.

Therefore, fast track status for RSV-F in the elderly population cannot be ruled out as a possible announcement on September 24th. I also want to establish here and now that fast track status for RSV in the remaining two populations - infants and women of childbearing age - remains an open possibility down the line just not within the time frame specified here.

Other possibilities include enhancement of the government's contribution to the pandemic program. BARDA has already committed to seeing both influenza programs through to licensure in terms of reimbursement of all trial costs. Perhaps they'll offer to do more in light of the phenomenal speed and efficacy demonstrated by Novavax in their H7N9 development that occurred in a record 91 days.
static.cdn-seekingalpha.com/uploads/2013/8/16/4021161-13766462440713856-Michael-Webb.png

Bill and Melinda Gates, through PATH, have generously supported RSV-F in women of childbearing age. Perhaps they've offered additional support as the program advances toward completion.

And then in addition to tamping out the fire of fast track status for RSV in the infant and women of childbearing age populations at Wedbush, Stanley Erck stirred the brewing pot of investor interest speaking for the first time in my memory of partnership discussions that included marketing territories for its entire pipeline of drug candidates.

The possibilities are as numerous and varied as Novavax's growing list of institutional supporters that include...

Institution # of Shares Market Value
Vanguard 4.15M $9.47M
Ayer Capital Mgmt 2.77M $5.24M
State Street Corp 1.99M $4.54M
Abingworth 1.50M $1.91M
Ironwood Investment 1.49M $1.87M

There were 21 more on that list including such brick and mortar staples as Charles Schwab, RA Capital Management and Goldman Sachs.

Oh, and try not to forget the Stifel Nicolaus Healthcare Conference on September 11th and 12th where President Erck will once again take the podium and move our imagination.

In conclusion, this article and the previous two pointed to a bright future for Novavax and indicated that the company was extremely undervalued. This past week, William Tanner of Lazard Capital Markets agreed with that position.

It's always satisfying to have one's work validated by so-called "experts" but investment in this sector carries considerable risk regardless.

Please, consult a financial advisor before making any investment decision and always be well.

Source: Novavax: Big Pharma Wants RSV Bad
Additional disclosure: The purpose of my article is to provide information the accuracy of which is as good as the public sources it was derived from. If providing my opinions on matters related to any investment has entertained you then I have accomplished my only goal. Do not act on anything I have written. Rather, do your own due diligence and consult an investment professional before making any investment decision. Acting on what any one writer, including me has imparted to you is foolish at best. I have no better access to resources or gift of opinion formulation than you do. There are a myriad of things which can happen in lieu of any forward looking statement I have made. Any stock featured in an article I compose is subject to all manner of influences which can change its value in dramatic fashion upwards or downwards. Invest at your own risk and attain the reward your efforts have wrought.

[dothedd]

Hot Stock: Novavax, Shares Gain 5.7% (NVAX)  


Aug 19, 2013 (SmarTrend(R) Spotlight via COMTEX) -- Novavax (NASDAQ:NVAX) is one of today's best performing low-priced stocks, up 5.7% to $2.80 on 1.3x average daily volume. Thus far today, Novavax has traded 2.8 million shares, vs. average volume of 2.1 million shares per day. The stock has outperformed the Dow (5.7% to the Dow's -0.1%) and outperformed the S&P 500 (5.7% to the S&P's -0.1%) during today's trading.

Novavax, Inc. is a clinical stage biotechnology company. The Company creates novel vaccines to address a broad range of infectious diseases worldwide using proprietary virus-like particle (VLP) technology.

In the past 52 weeks, shares of Novavax have traded between a low of $1.52 and a high of $2.93 and are now at $2.80, which is 84% above that low price. Over the last five market days, the 200-day moving average (MA) has gone up 0.4% while the 50-day MA has advanced 2.7%.

There is potential upside of 67.9% for shares of Novavax based on a current price of $2.80 and an average consensus analyst price target of $4.70. Novavax shares have support at the 50-day moving average (MA) of $2.34 and additional support at the 200-day MA of $2.09.

SmarTrend recommended that subscribers consider buying shares of Novavax on July 2nd, 2013 as our proprietary SmarTrend analytics indicated a new Uptrend was in progress when shares hit $2.20. Since that recommendation, shares of Novavax have risen 20.7%. We continue to monitor NVAX for any potential shift so investors can protect gains and will alert SmarTrend subscribers immediately.

[dothedd]

Genocea Biosciences Selected To Present Late-Breaking Oral Presentation At ICAAC 2013

August 28, 2013 8:00 AM ET

—Abstract describes positive data from an interim analysis of Genocea's Phase 1/2a clinical study of GEN-003, a therapeutic vaccine for herpes simplex virus type 2—

CAMBRIDGE, Mass., Aug. 28, 2013 /PRNewswire/ -- Genocea Biosciences Inc., a clinical-stage company developing T cell vaccines to prevent and treat infectious diseases, announced today that its abstract describing an interim analysis of data from a Phase 1/2a clinical study of its lead candidate, GEN-003, has been selected as a late-breaking oral presentation at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013). GEN-003 is a first-in-class, investigational protein subunit vaccine for patients with moderate-to-severe herpes simplex virus type 2 (HSV-2) infection.

The abstract is entitled "Novel Therapeutic Vaccine for Genital Herpes Reduces Genital HSV-2 Shedding." Dr. Anna Wald, the Principal Investigator on the study, will present the detailed interim data during a session on Vaccine Development and Efficacy on September 12 in Denver, Colorado.

"We are pleased that ICAAC has chosen to accept our abstract given the limited number of late-breaking submissions that are selected, and believe that this acceptance reflects the quality of the study to be presented and the need for new therapeutic approaches to the HSV-2 epidemic," said Chip Clark, President and Chief Executive Officer of Genocea.

The following abstract will be presented:
Presentation number G-1458a, "Novel Therapeutic Vaccine for Genital Herpes Reduces Genital HSV-2 Shedding," 3:00 – 5:30 p.m. MDT, September 12, 2013, Meeting Room 503.

About GEN-003
GEN-003 is a first-in-class T cell vaccine intended to reduce the viral shedding and frequency and severity of outbreaks and transmission of herpes simplex virus type 2 (HSV-2). GEN-003 is designed to induce a balanced and durable B cell (antibody) and T cell immune response.

GEN-003 includes fragments of ICP4 and gD2 antigens, as well as the proprietary adjuvant, Matrix-M™, licensed from Isconova AB. The adjuvant is a novel saponin-derived product that has demonstrated a balanced B and T cell immunostimulatory profile in previous clinical studies.

There is currently no vaccine approved to prevent or treat HSV-2. For more information about clinical studies for GEN-003 please visit www.clinicaltrials.gov. For more information about GEN-003, please visit www.genocea.com/pipeline/hsv-2-faq.html.

About HSV-2
Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide, and one out of six people aged 14 to 49. In the U.S., an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores and, due to the stigma associated with this disease, can impact patients' ability to form and maintain relationships, resulting in considerable psychological distress in patients. No vaccine is currently approved to prevent or treat the disease.

About Genocea Biosciences
Genocea Biosciences is harnessing the power of T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify protective T cell antigens in humans exposed to a pathogen using ATLAS™, its proprietary technology platform that mimics the human immune response in the laboratory, potentially improving the effectiveness of vaccine candidates and drastically reducing the time needed to create them. Genocea's pipeline of novel T cell vaccines includes GEN-003 for HSV-2 therapy, GEN-004, a protein vaccine directed at pneumococcus that is expected to enter the clinic in the fourth quarter of 2013, and earlier-stage programs in chlamydia, HSV-2 prophylaxis and malaria.

For more information, please visit the company's website at www.genocea.com.

About Isconova
Isconova AB is a leading international vaccine adjuvant company headquartered in Uppsala, Sweden. With deep knowledge of vaccine systems, Isconova is developing vaccines independently and with partners in both the human and veterinary markets. Isconova is a subsidiary of Novavax, Inc. (NASDAQ "NVAX"). For more information on Isconova: www.isconova.com.

[dothedd]

Genocea's recent abstract on the vaccine in guinea pigs: NVAX's MM-2 clearly boosted the effects

J Virol. 2013 Apr;87(7):3930-42. doi: 10.1128/JVI.02745-12. Epub 2013 Jan 30.

An adjuvanted herpes simplex virus 2 subunit vaccine elicits a T cell response in mice and is an effective therapeutic vaccine in Guinea pigs.

Skoberne M, Cardin R, Lee A, Kazimirova A, Zielinski V, Garvie D, Lundberg A, Larson S, Bravo FJ, Bernstein DI, Flechtner JB, Long D.

Source

Genocea Biosciences, Inc., Cambridge, Massachusetts, USA.

Abstract

Immunotherapeutic herpes simplex virus 2 (HSV-2) vaccine efficacy depends upon the promotion of antigen-specific immune responses that inhibit reactivation or reactivated virus, thus controlling both recurrent lesions and viral shedding. In the present study, a candidate subunit vaccine, GEN-003/MM-2, was evaluated for its ability to induce a broad-spectrum immune response in mice and therapeutic efficacy in HSV-2-infected guinea pigs. GEN-003 is comprised of HSV-2 glycoprotein D2 (gD2ΔTMR340-363) and a truncated form of infected cell polypeptide 4 (ICP4383-766), formulated with Matrix M-2 (MM-2) adjuvant (GEN-003/MM-2). In addition to eliciting humoral immune responses, CD4(+) and CD8(+) T cells characterized by the secretion of multiple cytokines and cytolytic antigen-specific T cell responses that were able to be recalled at least 44 days after the last immunization were induced in immunized mice. Furthermore, vaccination with either GEN-003 or GEN-003/MM-2 led to significant reductions in both the prevalence and severity of lesions in HSV-2-infected guinea pigs compared to those of phosphate-buffered saline (PBS) control-vaccinated animals. While vaccination with MM-2 adjuvant alone decreased recurrent disease symptoms compared to the PBS control group, the difference was not statistically significant. Importantly, the frequency of recurrent viral shedding was considerably reduced in GEN-003/MM-2-vaccinated animals but not in GEN-003- or MM-2-vaccinated animals. These findings suggest a possible role for immunotherapeutic GEN-003/MM-2 vaccination as a viable alternative to chronic antiviral drugs in the treatment and control of genital herpes disease.

You would not, of course, have expected an adjuvant to act on its own, so that was no problem.

Reduction of viral shedding is very important in this disease because it reduces infectivity. Clearly the use of Novavax's MM-2 as important to the results.

They would not have applied for a late breaker unless they results were good and it would not have been granted if the results were not clearly significant. So it looks like this event (the ICAAC on 12 Sept) should provide a significant boost for Novavax and nicely timed just ahead of their 24 Sept presentation.

[dothedd]

At Least 320,000 Viruses Lurk in Mammals, Study Finds

September 03, 2013 Live Science

From West Nile and Ebola to SARS and HIV, most of the emerging infectious diseases that plague humans today originated in other animals. According to a new estimate, there are at least 320,000 viruses in mammals alone, the vast majority of them awaiting discovery.

Scientists say that collecting data on pathogens that may lurk in wildlife before they jump to humans could help officials detect and stem future outbreaks.

"What we currently know about viruses is very much biased towards those that have already spilled over into humans or animals and emerged as diseases," study author Simon Anthony, of the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health, said in a statement.

Drudge Report just announced a plan to begin, real-time, Global 24/7 Surveillance of such viruses. Using this data, combined with advanced computer programs that can evaluate DNA sequencing and predict reassortment, they expect to be able to use this data to predict the next Pandemic. (You'll be reading about this soon).

What does this have to do with NVAX? Everything... Safe vaccines produced in record time.

[dothedd]

Sept 4, 2013 9:03:11 GMT -5 @lonewolf said:

VERY GREAT NEWS:

Novavax Appoints Barclay “Buck” Phillips as Senior Vice President and Chief Financial Officer

I feel like a hypocrite, as even though I disapprove of vaccines, I am seriously thinking of buying into Noravax.

 

Well, what can I say!  It will be the safest vaccine on the market. 

[dothedd]

Press Release $NVAX Novavax, Inc.

 11 Sep



ICAAC Presentations Highlight Potential Protective Effects of Novavax' RSV Vaccine Candidate

ROCKVILLE, Md., Sept. 11, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.

In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: "RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders"), Novavax' RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching 184µg/ml. Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.

In a separate preclinical study (Poster B-501a: "Passive Immunization with RSV F Vaccine-Induced Polyclonal Antibodies Protect Cotton Rats From RSV A Challenge"), investigators evaluated whether palivizumab-competing antibodies induced by the RSV F vaccine could provide passive protection in a relevant model. Palivizumab (Synagis®), a monoclonal antibody currently used to prevent RSV disease, was previously studied in the cotton rat model, which provided guidance for later licensing studies.

"These presentations reflect our progress in defining the importance of the palivizumab-like antibody and confirm that the RSV F vaccine induces promising immune responses in the elderly population," said Gregory Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax. "These two studies are important because they demonstrate the potential of our vaccine candidate to prevent a major public health problem in the elderly and also provide protection to infants through passive maternal immunization. These are critical unmet needs which we plan to address in later-stage efficacy studies."

Both posters are available under the "Publications and Presentations" section of the Novavax website at www.novavax.com.

About RSV

RSV is a major respiratory pathogen in all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and causing approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. Currently, there is no approved RSV prophylactic vaccine available.

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, as well as new and efficient manufacturing approaches, 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.

Forward-Looking Statements

Statements herein relating to the future of Novavax and its ongoing development of its recombinant nanoparticle vaccine products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012, and Form 10-Q for the period ended June 30, 2013, both filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place considerable reliance on forward-looking statements contained in this press release and encouraged to read the Company's filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and Novavax undertakes no obligation to update or revise any of the statements. Novavax' business is subject to substantial risks and uncertainties, including those referenced above and investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000


Source: Novavax, Inc.

[dothedd]

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[dothedd]

NEW NVAX RSV - data from Poster, Denver - today. New 52 week high pending.

ROCKVILLE, Md., Sept. 11, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX) a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported positive findings from recent clinical and preclinical studies of its respiratory syncytial virus F-protein (RSV F) nanoparticle vaccine candidate in poster sessions at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.

In a Phase 1 clinical study of 220 healthy elderly adults 60 years of age and older (Poster B-501d: "RSV F Protein Vaccine Is Well-Tolerated and Immunogenic in Elders"), Novavax' RSV F vaccine candidate was found to be compatible with co-administration of an influenza vaccine, well-tolerated and elicited increases in antibodies with potentially protective effects. In the study, subjects were randomized to receive one dose of 60 or 90 micrograms of RSV F protein with or without an aluminum adjuvant, or placebo. All subjects received trivalent inactivated influenza vaccine to mimic anticipated co-administration of both vaccines. The RSV F vaccine elicited up to a 5 fold increase in serum anti-F IgG with titers of palivizumab-competing antibodies reaching 184ug/ml. Changes in all measures of RSV antibodies, including microneutralization assays, were positively correlated. The RSV F vaccine did not interfere with responses to the influenza vaccine. Top-line results from this study were reported previously by Novavax in July.

[dothedd]

ALL ABOUT NOVAVAX

Company Overview: (from the recent Wedbush conference).

• Next Generation Vaccine Technology:
‒ Recombinant Nanoparticle Vaccines: Virus-Like Particles (VLPs), Micelles
‒ Proprietary saponin-base adjuvant (Matrix-M).

• Late-Stage Development Programs:
‒ RSV - Recent positive data from 2 separate Phase 2 trials, PATH Funding support
‒ Seasonal Flu – novel recombinant vaccine funded under BARDA contract
‒ Pandemic influenza - Breakthrough immunogenicity and dose sparing

• Demonstrated ability to address emergent disease threats:
‒ H7N9 flu vaccine developed; testing in human subjects in only three months
‒ H5N1 flu vaccine funded under BARDA contract
‒ Middle East Respiratory Syndrome (MERS) vaccine in development
‒ Flexible manufacturing capacity

• Strong balance sheet, new experienced management team

[dothedd]

"Interesting, the price-climb just bounced off of that $3.25 level which happens to be the 50% retracement level when setting up a Fibonacci retracement for the last 5 years. Will be interesting to see what happens from here...."

I'm topped-out in the $2.00's, but did anyone here get in at $3.14/3.15?

Just asking!    I BET THAT IS GRAPE JUICE!