We feel a duty to exploit our full technology and immunotherapy expertise to help address the COVID-19 pandemic emergency. Our aim is clear: Making a potential vaccine available to the public as quickly as possible – worldwide.
Prof. Ugur Sahin, M.D., Chief Executive Officer
We are developing a potential vaccine based on our proprietary mRNA technology to induce immunity and prevent COVID-19 infections in response to the growing global health threat. In order to accelerate the rapid development of our product candidate BNT162 we initiated the global development program Lightspeed. The program leverages
BioNTech was able to bring its first vaccine candidates from concept into clinical development in less than three months. Safety, speed and flexibility are of the utmost importance in reacting to the current pandemic. Efforts to manufacture the leading candidates, at our risk, are gearing up. In case the safety and efficacy study is successful, BioNTech and Pfizer plan to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021.
SARS-CoV-2 is a member of a large family of coronaviruses consisting of spherically-shaped viral particles covered with spike proteins protruding from their surface, which give the virus its crown-like appearance. These spikes bind onto human cells, allowing the virus to infect them. Our vaccine consists of a short segment of genetic material, called messenger RNA, that provides instructions for a human cell to make a harmless version of a target protein, or immunogen, which activates the body’s immune response against the SARS-CoV-2 virus. We expect that our vaccination approach will stimulate the immune system to generate protective antibodies. This means the immune systems learns how to recognize the SARS-CoV-2 virus upon exposure and prevent subsequent infection. Unlike other vaccines, mRNA vaccines do not contain the virus itself and therefore pose no risk of infection.
mRNA vaccines consist of genetic material, called messenger RNA, that provides instructions for a human cell to make a target protein, or immunogen, which activates the body’s immune response against the respective virus. The goal of a vaccine is to stimulate the immune system to generate protective, long-lasting antibody and T cell responses against SARS-CoV-2 and prevent subsequent infection upon exposure to the virus. mRNA vaccines are a potent new developmental class of vaccines with potential for high versatility and favourable safety properties.
BioNTech was one of the first European company to enter clinical testing, having started a clinical trial in Germany in April and a further clinical trial in the United States at the beginning of May. BioNTech’s development programme for BNT162 is one of the broadest development programmes globally, with four vaccine candidates being tested in parallel. 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.
In July, BioNTech and Pfizer announced their lead candidate: BNT162b2. The nucleoside-modified messenger RNA (modRNA) candidate BNT162b2 from their BNT162 mRNA-based vaccine program against SARS-CoV-2 will be tested at a 30 µg dose level in a two dose regimen into a global Phase 2/3 Study. 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.
The candidate and dose level selection was informed by an extensive review of preclinical and clinical data obtained in Phase 1/2 studies conducted in the U.S. and Germany, and in consultation with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER). BNT162b2, one of the two BNT162 candidates to recently have received Fast Track designation by the U.S. Food and Drug Administration (FDA), encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of neutralizing antibodies that are believed to inactivate the virus.
During preclinical and clinical studies of four BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. Pfizer and BioNTech selected BNT162b2 as the candidate to progress to a Phase 2/3 study based on the totality of available data from our preclinical and clinical studies, including selected immune response and tolerability parameters.
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 U.S. data from the most advanced of the four investigational vaccine candidates from our BNT162 mRNA-based vaccine program were announced on 1 July 2020. Overall, the preliminary data it was demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.
On July 20, 2020, BioNTech and Pfizer announced preliminary data from our ongoing German Phase 1/2 trial of BNT162b1. The initial part of this open-label, non-randomized, non-placebo-controlled study is evaluating the safety, tolerability and immunogenicity of escalating dose levels of BNT162b1, one of four vaccine candidate variants in development as part of our BNT162 program. In 34 of the 36 subjects who received two vaccinations at 10µg, 30µg, or 50µg dose levels of BNT162b1, RBD-specific CD4+ T cell responses were observed. All subjects but the two exceptions at the lowest dose level had cytokine profiling of the RBD-specific CD4+ T cells that demonstrated a TH1-dominant profile for these cells.
Fast Track is a process designed to facilitate the development, and expedite the review, of new drugs and vaccines that are intended to treat or prevent serious conditions that have the potential to address an unmet medical need. This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany as well as animal immunogenicity studies.
The collaboration with Pfizer builds on the 2018 agreement to jointly develop an mRNA-based influenza vaccine. It aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network. During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. BioNTech and Pfizer will also work jointly to commercialize the vaccine worldwide (excluding China which is already covered by BioNTech’s collaboration with Fosun Pharma) upon regulatory approval.
As part of their strategic collaboration announced in March 2020, BioNTech and Fosun Pharma will jointly conduct clinical trials of BNT162 in China, leveraging BioNTech’s proprietary mRNA vaccine technology and Fosun Pharma’s clinical development and commercialization capabilities in China. Fosun Pharma will commercialize the vaccine in China upon regulatory approval.