Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-CoV-2

Advertisement - Covance

Pfizer Inc. and BioNTech SE announced that preliminary, peer-reviewed data from their BNT162 mRNA-based vaccine development program, Project Lightspeed, against SARS-CoV-2, were published online in the journal Nature. These preliminary clinical data on BNT162b1, a nucleoside-modified messenger RNA (modRNA) candidate that encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, showed that BNT162b1 was 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 titers. These data were made available to the public on July 1, 2020 via an online preprint server, medRxiv. For additional details, please read the previously issued press release.

The posted preprint version of the manuscript reported that, by 7 days after the second dose, 30µg of BNT162b1 elicited a SARS-CoV-2 neutralizing geometric mean titer (GMT) 2.8-times the GMT of a SARS-CoV-2 convalescent human serum panel. Based on new data, the final, peer-reviewed paper reports that neutralizing titers continued to rise, and, by 14 days after the second dose of 30µg, the participants’ GMT was 4.6-times the convalescent serum panel GMT.

“The publication of peer-reviewed data from our mRNA-based vaccine development program against SARS-CoV-2 in a world-renowned publication like Nature provides further validation of our rapid progress toward developing a safe and effective potential vaccine to help address this current pandemic,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are encouraged by the overall advancement of the program and look forward to generating additional data from our ongoing studies.”

“Since our inception, we have been deeply grounded in science, which makes sharing our data in a peer-reviewed publication like Nature an even more important milestone. The scientific rigor of our approach is fundamental during the current pandemic. Supporting the growing body of knowledge is instrumental for finding answers to benefit global health,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We aim to continuously follow that scientific rigor in reporting additional data from our global trials, which are ongoing at more than 100 clinical sites worldwide. Our aim remains to bring a safe and efficacious vaccine to the global community.”

Pfizer and BioNTech recently selected BNT162b2 as the vaccine candidate to progress to a Phase 2/3 study, which is now enrolling. BNT162b2 was selected based on the totality of available data from preclinical and clinical studies, including select immune response and tolerability parameters compared to the BNT162b1 candidate. The companies are continuing to collect data from the Phase 1/2 trials and expect to submit data on BNT162b2 for peer-review and potential publication in the near future. In keeping with their commitment to transparency, the companies intend to also post the manuscript on a preprint server at that time.

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. For further information about this trial, visit www.ClinicalTrials.gov using the number NCT04368728.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. 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. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.