Facing Pandemic — from Mainz to the world BioNTech making a potential vaccine available worldwide as quickly as possible
BioNTech SE and Pfizer Inc. have released their preliminary, peer-reviewed data from their ongoing German Phase 1/2 Study of BNT162b1. BNT162b1 is a nucleoside-modified messenger RNA (modRNA) candidate that encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen. The data was published online in the journal Nature.
BNT162b1 is part of the companies’ mRNA-based vaccine development program Lightspeed against SARS-CoV-2. The preliminary clinical data from the German study of BNT162b1, supported and expanded the data from the Phase 1/2 US study. The initial German trial results demonstrated, for the first time for the BNT62b1 candidate, a concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. The data were initially made available to the public on July 20, 2020 via the online preprint server, medRxiv.
The companies are also continuing the peer-review process for other previously announced results from their BNT162b2 studies. BNT162b2 has been selected as the vaccine candidate to advance into a Phase 2/3 study based on the totality of available data from preclinical and clinical studies. As of 30 Sept, 2020, the trial had enrolled over 35,000 participants, and the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.
The Phase 2/3 study is an event-driven trial that is planned to enroll up to 44,000 participants between 16 and 85 years of age. The companies are enrolling a diverse population, including participants in areas where there is significant expected SARS-CoV-2 transmission.
Biopharmaceutical New Technologies (BioNTech) was founded in 2008 on the understanding that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. They have combined ground-breaking research with cutting-edge technologies to develop pioneering therapeutics for cancer and beyond. From their roots in Mainz, Germany, BioNTech is driven to become the leading global biotechnology company for individualized cancer medicine.They are aiming to address the global pandemic and their goal is clear: making a potential vaccine available worldwide as quickly as possible.
For more information, please visit www.BioNTech.de.
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