Company Update (NASDAQ:NVAX): Novavax, Inc. Gets Phase 1/2 Trial Enrollment Started in NanoFlu Vaccine in Older Adults


Novavax, Inc. (NASDAQ:NVAX) announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M adjuvant (NanoFlu) in older adults.

The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).

“The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD,” said Gregory Glenn, M.D., President of Research and Development. “We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.

“Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection.”

“The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic,” said Stanley C. Erck, President and CEO. “Seasonal influenza remains a significant threat to older adults, with nearly three million infections and over 250,000 hospitalizations annually1. Our goal is to deliver a differentiated flu vaccine to the greater than $3 billion global seasonal influenza commercial market2 and we look forward to delivering clinical data from this trial by the end of the year.” (Original Source)

Shares of Novavax are currently rising 0.09% to $1.12 in Tuesday trading. NVAX has a 1-year high of $2.47 and a 1-year low of $0.73. The stock’s 50-day moving average is $1.05 and its 200-day moving average is $1.09.

On the ratings front, Novavax has been the subject of a number of recent research reports. In a report issued on August 10, Cantor Fitzgerald analyst William Tanner reiterated a Hold rating on NVAX, with a price target of $2, which represents a potential upside of 79% from where the stock is currently trading. Separately, on August 9, Ladenburg Thalmann’s Kevin Degeeter upgraded the stock to Buy.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, William Tanner and Kevin Degeeter have a yearly average return of 18.8% and 9.3% respectively. Tanner has a success rate of 60% and is ranked #306 out of 4651 analysts, while Degeeter has a success rate of 51% and is ranked #1114.

Novavax, Inc. 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.