Clinical-stage biotechnology company BioNTech SE (BNTX:NASDAQ) and pharmaceutical giant Pfizer Inc. (PFE:NYSE) today announced that "two of the companies' four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA)." The companies stated that BNT162b1 and BNT162b2 are presently being evaluated in ongoing Phase 1/2 clinical trials in the U.S. and Germany and are the two most advanced vaccine candidates in the collaborative BNT162 program.
The firms explained that the FDA's Fast Track program is designed to expedite the development and review of new drugs and vaccines and that the Fast Track designation was granted based upon preliminary data from ongoing Phase 1/2 trials in Germany and the U.S. and also from additional animal immunogenicity studies.
The company pointed out that "the BNT162 program is evaluating at least four experimental vaccines, each of which represent a unique combination of messenger RNA (mRNA) format and target antigen."
Pfizer's SVP of Global Regulatory Affairs Peter Honig commented, "The FDA's decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2...We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates."
BioNTech's Chief Medical Officer Özlem Türeci remarked, "We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward."
The company noted that "the Project Lightspeed vaccine development program is based on BioNTech's proprietary mRNA-based technology platforms and supported by Pfizer's global vaccine development capabilities." Subject to regulatory approval, the companies hope to enroll up to 30,000 patients in a Phase 2b/3 trial possibly as early as later this month. If the Phase 2b/3 study produces successful results and the vaccine candidate is granted regulatory approval, the companies stated that they plan to manufacture up to 100 million doses of the vaccine by December 2020 and as many as 1.2 billion doses by the end of 2021.
BioNTech is based in Mainz, Germany, and is focused on providing next generation immunotherapies for cancer and other serious diseases. The firm stated that "its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules."
Pfizer is a research-based global biopharmaceutical company headquartered in New York, that is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio is composed of many household name brand prescription medications including Prevnar 13, Xeljanz, Eliquis, Lipitor, Celebrex, Pristiq and Viagra. The firm's shares trade on the NYSE and it has a market cap of approximately $188 billion.
BioNTech began the day week with a market capitalization of around $16.1 billion with approximately 228.6 million shares outstanding. BNTX shares opened 11.5% higher today at $78.47 (+$8.11, +11.53%) over Friday's $70.36 closing price. The U.S. ADR stock has traded today between $75.75 and $84.89 per share and is currently trading at $81.19 (+$10.83, +15.39%).
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