- Pfizer is quickly advancing its COVID-19 drug research toward human studies, disclosing Thursday plans to start clinical testing by this fall of an antiviral compound it's been developing, three or more months ahead of schedule.
- By then, Pfizer and partner BioNTech could be several months into initial trials of an experimental vaccine for the new coronavirus, which the companies said they would begin in April when they announced their collaboration three weeks ago.
- If achieved, an April study start would put the two companies only weeks behind early leaders Moderna, CanSino Biologics and Inovio Pharmaceuticals in the race to speed vaccine prototypes into Phase 1 trials of healthy volunteers.
Pfizer's pursuing several coronavirus therapies in parallel, betting that multiple types of treatment will be needed to curb a pandemic that's sickened more than 1.5 million people globally through April 9.
Like many companies, Pfizer said in early March it was screening antiviral compounds for activity against SARS-CoV-2, the scientific name for the new coronavirus. Then, the pharma set a goal of beginning clinical studies by the end of 2020, a timeline that's been now been accelerated by several months.
Pfizer said it has selected a lead compound, a type of drug known as a protease inhibitor, that initial preclinical testing has shown to be active against SARS-CoV-2. Protease inhibitors, several of which are approved to treat HIV and hepatitis C infections, work by blocking enzymes critical to the process by which viruses replicate themselves.
Further confirmatory studies will be conducted before Pfizer moves the drug into human studies by the third quarter of this year.
Pfizer's work with BioNTech, meanwhile is moving even faster. The companies had first announced an agreement-in-principle to allow for work on the German biotech's mRNA vaccine to begin immediately.
Under terms also announced Thursday, Pfizer will pay BioNtech $72 million in cash and invest another $113 million in the company as part of the partnership deal. In addition, the pharma will split the costs of development with BioNTech, which could receive up to $563 million in further milestone-based payments.
It's a sizable sum, and reflects the increased investment larger drugmakers are making in COVID-19 drug development. This week, for example, GlaxoSmithKline said it would invest $250 million in Vir Biotechnology and its work on neutralizing antibodies against SARS-CoV-2.
Larger partners like Pfizer and GSK are particularly critical if early work shows a treatment to be promising. Many smaller biotechs lack the manufacturing capacity to produce a drug at the kind of scale necessary for beating back a pandemic.
While BioNTech will provide supplies of its mRNA vaccine from facilities it owns in Europe, Pfizer said it will begin working with the biotech to scale up production.
The companies said they could supply millions of vaccines doses by the end of 2020 and hundreds of millions of doses by next year, if testing proves successful.
mRNA vaccines, like the one Pfizer and BioNTech are developing together, are a new technology. And while they're easier to design and produce than typical protein-based vaccines, none are approved for use in treating any disease. The urgency of the coronavirus pandemic has also forced drugmakers to move quickly, condensing usual timelines for preclinical and animal testing that can provide valuable information on how an experimental vaccine could be expected to work in humans.
Initial Phase 1 tests are designed to gauge safety and immune responses, and are the first step in a clinical process that usually stretches over years. Drug company executives, as well as U.S. government officials, hope a vaccine for SARS-CoV-2 could be ready within 12 to 18 months, an unusually fast timeline.