Novavax, Inc. (NASDAQ:NVAX) announced the Phase 3 trial of its RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization will continue. Novavax also provided an update on its nanoparticle influenza vaccine candidate with proprietary Matrix-M™ adjuvant (NanoFlu™).
RSV F Vaccine for Infants via Maternal Immunization
“Novavax has completed an informational analysis of our Phase 3 trial of the RSV F Vaccine for infants via maternal immunization using threshold criteria for a commercial product. As a result, we are accelerating our Phase 3 trial enrollment into 2018. Our maternal immunization program is supported by an $89 million grant from the Bill and Melinda Gates Foundation and has also been granted Fast Track designation by the U.S. Food and Drug Administration,” said Stanley C. Erck, President and CEO. “We have enrolled over 3,000 volunteers to date and anticipate that the current pace of enrollment would trigger an interim analysis in mid-2018, with an expected Phase 3 primary endpoint readout in early 2019. This timing would allow us to submit a biologics license application (BLA) by the end of 2019.”
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A number of key scientific developments regarding influenza vaccines for the current season have occurred and relate to our NanoFlu program, including:
- A November 29, 2017, editorial in the New England Journal of Medicine1 detailed public health concerns related to the poor efficacy of existing seasonal influenza vaccines that is due, in part, to genetic changes or drift in the hemagglutinin (HA) protein, leading to low vaccine efficacy
- Based on analyses from the Southern Hemisphere, the effectiveness of the seasonal influenza vaccine was as low as 10% for the A(H3N2) strain2
- A November 6, 2017, Proceedings of the National Academy of Sciences3 publication identified that the circulating influenza A(H3N2) virus contains an HA structure that has been lost in the corresponding vaccine strain during adaptation to be grown in eggs (“egg-adapted”) as part of the typical seasonal influenza vaccine manufacturing process, which, in turn, affects vaccine efficacy for egg-based vaccines
- Novavax’ NanoFlu vaccine candidate is designed specifically to address these challenges
- The wild-type viruses necessary to assess immunogenicity of the vaccines to circulating strains have been difficult to obtain, grow and maintain genetic stability
- Therefore, a complete Phase 1/2 data package expected in February 2018
“Recent information published presents both an opportunity and a challenge for our NanoFlu Vaccine program. First, we have the unique opportunity to determine whether our recombinant, adjuvanted NanoFlu vaccine can address egg-adapted virus mismatch. We can also observe whether our vaccine-induced antibodies can neutralize circulating viruses with antigenic drift in humans, as we demonstrated in our ferret study earlier this year,” said Greg Glenn, M.D., President, R&D. “Our team has been able to optimize our assays to address this challenge and we expect to present NanoFlu immunogenicity data that includes HA inhibition and microneutralization assays comparing wild-type virus and egg-based reagents.”
Shares of Novavax reacted to the news, falling nearly 19% to $1.21 in after-hours trading Tuesday. NVAX has a 1-year high of $1.78 and a 1-year low of $0.73. The stock’s 50-day moving average is $1.29 and its 200-day moving average is $1.15.
On the ratings front, Novavax stock has been the subject of a number of recent research reports. In a report issued on November 14, Cantor analyst William Tanner reiterated a Hold rating on NVAX, with a price target of $2.00, which represents a potential upside of 34% from where the stock is currently trading. On October 31, Citigroup’s Joel Beatty upgraded the stock to Buy and has a price target of $1.60.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, William Tanner and Joel Beatty have a yearly average return of 9.2% and a loss of -4.4% respectively. Tanner has a success rate of 51% and is ranked #779 out of 4719 analysts, while Beatty has a success rate of 38% and is ranked #4092.
Novavax operates as a clinical-stage biopharmaceutical company, which engages in the provision of development of recombinant nanoparticle vaccines and adjuvants. Its product pipeline targets infectious diseases with vaccine candidates in clinical development for respiratory syncytial virus, seasonal influenza, pandemic influenza, and Ebola virus.