Pfizer Inc. and BioNTech SE disclosed “positive” data from an early trial of their BNT162b2 mRNA-based vaccine candidate against SARS-CoV2 and confirmed that they were on track to seek regulatory review as early as October.
The news drove BioNTech (BNTX) shares up 10% on Friday, while Pfizer rose less than 1% at the close of day.
Pfizer (PFE) and BioNTech shared additional Phase 1 safety and immunogenicity data from their ongoing US study of the BNT162 mRNA-based vaccine program against Covid-19.
The newly released data shows key safety and immunogenicity data from the US Phase 1 trial for the BNT162b2 vaccine candidate, which at 30μg recorded 7 days after the second dose induced SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients.
In older adults (65-85 years of age) the vaccine candidate showed a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults. Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.
“The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials,” said Kathrin U. Jansen, Pfizer’s Head of Vaccine Research & Development. “We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the US trial and we look forward to sharing T cell immune response data from the German trial in the near future.”
The data results prompted the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study that started in July 2020. As of now, the study has enrolled more than 11,000 participants. It is now actively enrolled in the US, Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa. The study is an event-driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age.
Pfizer and BioNTech added that assuming regulatory approval is obtained, they currently plan to supply up to 100 million vaccine doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. The vaccine development program is evaluating at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.
Shares in BioNTech have spiked 116% so far this year and analysts forecast another 10% upside potential setting the average price target at $80.36.
Commenting on the trial data, H.C. Wainwright analyst Robert Burns said BNT162b2 appears to have an improved safety profile but nonetheless he reiterated a Hold rating on the stock.
“Despite the encouraging data, we cannot predict with any certainty what the vaccine may be able to achieve in sales, given the complexity and continually evolving epidemiology of COVID-19 and the rapidly changing nature of the competitive landscape,” Burns wrote in a note to investors.
Overall, Wall Street analysts have a cautiously optimistic outlook on the stock with a Moderate Buy consensus. (See BioNTech stock analysis on TipRanks).
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