- Infinity Pharmaceuticals on Tuesday said it would shut down its discovery research division and lay off 46 employees after a Phase 2 study of its lymphoma drug duvelisib showed a smaller-than-expected clinical benefit.
- Although duvelisib met its primary endpoint among patients with refractory indolent non-Hodgkin lymphoma, Infinity had hoped for a higher overall response rate than the 46% seen in the trial.
- Infinity also said it had reached an agreement with AbbVie to pause a Phase 1b/2 study evaluating the drug in combination with venetoclax, pending discussions on next steps following the results.
Development of duvelisib, a P13K inhibitor, represents the bulk of Infinity's R&D, with only one other asset currently in clinical stage. And with Infinity shutting down its discovery research division, the lackluster results appear to be a significant blow for the Cambridge, MA based biotech.
In a related filing with the Securities and Exchange Commission, Infinity said the layoffs would be "substantially complete" by July 1 and "fully completed" by year's end. Severance costs are estimated to be about $5 million, with another $3 million in expected contract termination and fixed asset impairment costs.
"This restructuring is a necessary step to preserve financial resources as we explore options for duvelisib and the advancement of IPI-549, our second clinical program," said Adelene Perkins, CEO of Infinity.
Infinity had entered into a co-development partnership with AbbVie to develop duveselib in September 2014, receiving a upfront payment of $275 million plus milestone payments. But those potential payments now look to be in doubt with further partnered development on hold.
In the Phase 2 study, duvelisib was tested in 129 patients with indolent non-Hodgkin lymphoma and demonstrated a 46% overall response rate, all of which were partial responses. Most of the side effects were reversible and clinically manageable, according to the company.
But other drugs already on the market, such as Gilead's Zydelig, have demonstrated higher benefit.
"While the Dynamo study met its primary endpoint, we hoped that treatment with duvelisib as a monotherapy would have provided a larger clinical benefit for patients with advanced indolent non-Hodgkin lymphoma," Perkins said.
Infinity has not scrapped duveselib altogether, and has plans to seek feedback from the FDA for its clinical program in non-Hodgkin lymphoma. But markets reacted sharply, with Infinity stock dropping nearly 72% in Tuesday trading. The stock now trades a little above $1 per share.
Duvelisib is being tested for other blood cancers, including a phase 3 study in relapsed indolent non-Hodgkin lymphoma (iNHL). Infinity's only other drug, IPI-549, is being evaluated in a phase 1 study for solid tumors, according to the company's website.