Drug Development

Playing catch-up, Regeneron and Sanofi push ahead on pivotal PD-1 cancer studies

Regeneron $REGN is wasting no time in pushing ahead with what it hopes is their first pivotal study for the latest in what is becoming a long line of PD-1 checkpoint drugs. In its earnings release this morning the big biotech says that it is recruiting patients for a potential registration Phase II study on advanced cutaneous squamous cell carcinoma.

Mark Schoenebaum

ISI analyst Mark Schoenebaum added in a note this morning that he’s keeping a close eye on their Phase II for non-small cell lung cancer, which also launches this year.

Sanofi $SNY committed back in 2015 to pay half of the $650 million development tab on REGN2810, part of a $1.8 billion package for a slate of immuno-oncology drugs — including monoclonal antibodies as well as bispecifics — that the two are now partnered on. Sanofi’s own efforts in cancer R&D stumbled badly, forcing a reorganization of its R&D efforts in one of many signs that the pharma giant can’t seem to find its own path on drug development.

Analysts see little to distinguish this PD-1 from the rest of the checkpoint field. But the next step in I/O involves a slew of combination therapies that will look to change the landscape on frontline therapies. Merck and Bristol-Myers Squibb got out in the market first, followed by Roche’s PD-L1 drug atezolizumab. Now AstraZeneca is fervently praying for a pivotal success on durvalumab/tremelimumab — a crucial program for this pharma giant — while Pfizer and Merck KGaA close in on their own program.

Regeneron scored a key court victory yesterday when the US Court of Appeals ruled in its favor on Praluent, staying a decision in January that the PCSK9 cholesterol drug should be jerked from the market due to the patent violations seen with rival Repatha. Regeneron and Sanofi also say that they’re ready to refile sarilumab after Sanofi’s Le Trait facility gets a clean bill of health. And they’re looking for a potential megablockbuster advance with a decision looking on dupilumab. Other late-stage milestones include a Phase III for REGN2222 (an RSV-F Antibody) and a late-stage test for fasinumab, an NGF antibody for pain.



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