Novavax (NVAX) is now beginning human testing in its Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373. Preliminary immunogenicity and safety results from the Phase 1 part of the trial are expected in July 2020, the company says.
NVX‑CoV2373 is a stable, prefusion protein that uses Novavax’s Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies.
“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic,” said Stanley C. Erck, CEO of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”
The Phase 1/2 clinical trial will be held in two parts. Phase 1 is a randomized, observer-blinded, placebo-controlled trial to evaluate the vaccine’s immunogenicity and safety, both adjuvanted with Matrix‑M and unadjuvanted. The trial is enrolling 130 healthy participants 18 to 59 years old at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix‑M and without.
If Phase 1 is successful, the Phase 2 part will begin ‘promptly’ says NVAX. It will be held in multiple countries, including the US, and would assess immunity, safety and Covid‑19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX‑CoV2373 during the pandemic, says Novavax. The trial is being supported by $388M in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
According to the Wall Street Journal, Novavax is already ramping up manufacturing for NVX‑CoV2373 even though trials are only beginning now. “Time is the most important thing here,” Erck told the publisher, adding that normally NVAX would wait 6-9 months before taking this step.
Shares in Novavax have exploded by 1059% year-to-date, and analysts have a firmly bullish Strong Buy stock consensus. The average analyst price target currently stands at $48 (3% upside potential). (See Novavax stock analysis on TipRanks).
Ladenburg Thalmann analyst Michael Higgins has just boosted his price target from $38 to $50. “Our higher price target reflects our continued confidence in the successful completion of development and global approval of NVX-CoV2373, with an increased estimate for the procurement of this vaccine in 2021, from 100M to 300M doses, at $10/dose, for a ~3% share of global vaccine consumption, with our continued assumption for a $5 CGS/dose” he explains.
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