Pfizer, BioNTech 'quietly' usher a 5th COVID-19 jab into the clinic: analyst

BioNTech and partner Pfizer have been working on four vaccine candidates against COVID-19, snagging FDA fast-track tags for two of them and pushing one into a 30,000-patient phase 3 study. Now, the duo is adding a fifth shot on goal, slated to enter a phase 1/2 study this month.

“Company management confirmed to us this fifth BNT162 COVID-19 construct to enter the clinic uses modified mRNA (modRNA) like BNT 162b2, which is currently in Phase 2/3 registrantion enabling trial,” wrote SVB Leerink analyst Daina Graybosch, Ph.D., in an investor note Friday.

“They said this new candidate showed preclinical promise and could be a follow-on candidate,” Graybosch wrote, adding that Pfizer, meanwhile, has picked a different candidate, BNT162c2, as another potential follow-on.

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All five efforts fall under the partners’ BNT162 program, but they use different mRNA formats and target antigens. Like its latest addition, dubbed BNT162b3, the two fast-tracked candidates use a nucleoside-modified RNA, or modRNA, while another prospect uses a uridine-containing mRNA, or uRNA, and the fourth uses self-amplifying mRNA.

Pfizer and BioNTech started the phase 2/3 study of its most advanced candidate, BNT162b2, in late July, with the goal of testing the vaccine in up to 30,000 people aged 18 to 85. The trial is expected to involve about 120 sites around the world, with a focus on those with a high prevalence of COVID-19 still in the community.

The trial will assess whether the vaccine can prevent COVID-19 infection in people who have never been infected by SARS-CoV-2, as well as those who have. The partners expect to report interim data in October and, “assuming clinical success,” they are “on track” for a regulatory filing the same month, they said when they kicked off the study.

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If the jab snags approval or authorization, the plan is to supply up to 100 million doses by the end of 2020 and about 1.3 billion doses by the end of 2021.

The duo may have trailed Moderna, which was first to get an mRNA vaccine—or any vaccine—for COVID-19 into the clinic, but its multicandidate approach could put it in a better spot than its rival.

“We like BioNTech's drive to iterate in innovation and believe multiple shots-on-goal puts them in a good position for the long-term catch-up vaccination, re-vaccination, and/or pandemic stockpiling markets,” Graybosch wrote.