June 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – After disappointing results from a mid-stage trial for a blood cancer drug, Infinity Pharmaceuticals said it was forced to slash 46 positions, about 21 percent of its workforce.
On Monday, Infinity said duvelisib, its investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, did not have as big of an effect on patients as the company hoped. In its Phase II study, duvelisib demonstrated an overall response rate of 46 percent, but they were all partial responses, the company said in a statement. Adelene Perkins, president and chief executive officer at Infinity, said the company had hopes treatment with duvelisib as a monotherapy would have provided a larger clinical benefit for patients with advanced indolent non-Hodgkin lymphoma. Perkins said the company plans to meet with the U.S. Food and Drug Administration to determine the next steps regarding duvelisib as a treatment for indolent non-Hodgkin lymphoma. of Infinity Pharmaceuticals fell more than 67 percent in premarket trading to $1.44 per share. The stock closed at $4.41 per share Monday afternoon.
Infinity’s Dynamo study evaluated 129 lymphoma patients whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy and found that 46 percent showed some response to the treatment. The overall response rate was 41 percent among patients with follicular lymphoma, 68 percent among patients with small lymphocytic lymphoma and 33 percent among patients with marginal zone lymphoma. Any reported side effects from the treatment were reversible and clinically manageable, the company said in a statement.
The layoffs are part of a restructuring that will close down the company’s discovery research organization. Perkins said the layoffs and closing of the research group is “a necessary step to preserve financial resources as we explore options for duvelisib and the advancement of IPI-549, our second clinical program.” Perkins said it was a difficult decision to shut down the group and terminate the employees and thanked them for their service.
After the less-than-satisfactory results of the Phase II Dynamo Study, Infinity said the company will conduct “ongoing and collaborative discussions” with AbbVie to explore the next steps in the combination study of duvelisib with venetoclax, a drug co-developed by AbbVie and Genentech. Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being investigated for the treatment of CLL and other blood disorders. As it stands, Infinity and AbbVie have agreed to temporarily halt the Phase Ib/II combination study currently underway. The study was designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with non-Hodgkin’s lymphoma or chronic lymphocytic leukemia.
Infinity said it plans to provide updated 2016 financial guidance following the resolution of its strategic activities that include the layoffs and the AbbVie collaboration. The previous financial guidance for 2016 should no longer be relied upon, the company said in a statement. In May Infinity reported revenue of $9.3 million for the first quarter, which the company said included funds from the collaboration with AbbVie.
