BioNTech and Pfizer move into Phase II/III study with COVID-19 vaccine candidate BNT162b2

Germany’s BioNTech (Nasdaq: BNTX) saw its shares close up 2.9% yesterday and rise a further 3.1% to $89.20 pre-market this morning, and partner US pharma giant Pfizer (NYSE: PFE) was up more than 3% post-market after, they revealed the start of a global (except for China) Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program, against SARS-CoV-2.

After extensive review of pre-clinical and clinical data from Phase I/II clinical trials, and in consultation with the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulators, Pfizer and BioNTech have chosen to advance BNT162b2 into the Phase II/III study, at a 30µg dose level in a 2 dose regimen. BNT162b2, which recently received FDA Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.

“Today, we are starting our late-stage global study which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase II/III trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” said Dr Ugur Sahin, chief executive and co-founder of BioNTech.