Pfizer (PFE) and BioNTech SE (BNTX) have announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.
Shares in Pfizer rose 2% in Monday’s after-hours trading, while BioNTech was up 6%.
After reviewing clinical data and consulting with the U.S. Food and Drug Administration (FDA) and other global regulators, the two companies have now chosen to continue their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen.
BNT162b2, which recently received FDA Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. said Ugur Sahin, CEO and Co-Founder of BioNTech.
“This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” he added.
In the preclinical studies, BNT162b1 and BNT162b2 candidates induced favorable viral antigen specific CD4+ and CD8+T cell responses, high levels of neutralizing antibody in various animal species, and beneficial protective effects in a primate SARS-CoV-2 challenge model.
Preliminary clinical Phase 1/2 data from nearly 120 patients demonstrated a favorable overall tolerability profile for BNT162b2, as compared to BNT162b1, with generally mild to moderate and transient (1-2 days) systemic events, such as fever, fatigue and chills and no serious adverse events.
The companies are continuing to collect data from the Phase 1/2 trials for all four vaccine candidates and expect to submit data on BNT162b2 for peer review and potential publication in the near future.
The Phase 2/3 study is an event driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age. The companies plan to enroll a diverse population, including participants in areas where there is significant expected SARS-CoV-2 transmission.
By the end of the trial, the Phase 2/3 study is expected to be active at approximately 120 clinical investigational sites around the world, including 39 states across the United States and countries including Argentina, Brazil, and Germany.
BNT162b2 remains under clinical study and is not currently approved for distribution. If the Phase 2/3 trial is successful, Pfizer and BioNTech expect to seek regulatory approval in October 2020- with an ultimate goal of supplying globally up to 1.3 billion doses by the end of 2021.
Shares in Pfizer are down 4% year-to-date, while BioNTech has exploded over 150%. Looking forward, analysts take a cautiously optimistic Moderate Buy consensus on both stocks. (See Pfizer stock analysis on TipRanks)