Infinity Pharmaceuticals said today it will shut down its discovery research operation and eliminate 46 jobs—21% of its workforce—following underwhelming Phase II  results for its lead candidate duvelisib in refractory indolent non-Hodgkin lymphoma (iNHL).

The 46 jobs will be cut from “across the organization” under the planned restructuring, which is expected to be completed substantially by July 1 and completed fully by December 31, 2016, Infinity said in a regulatory filing.

The company said it expected to incur approximately $6 million to $8 million in total restructuring costs. Those include severance, benefits, and related costs of approximately $5 million, contract termination costs of up to approximately $2 million, and potential fixed-asset impairments of approximately $1 million.

Infinity plans to record most the restructuring charges as R&D expenses during the 3 months ending June 30. The company expects to pay out $4 million of the expected $5 million related to severance, benefits, and related costs this year and the remaining $1 million in 2017. 

“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,” Infinity President and CEO Adelene Perkins said in a statement.

Duvelisib met its primary endpoint of overall response rate in the Phase II DYNAMO™ study.
DYNAMO assessed the efficacy and safety of duvelisib (25 mg twice daily) as a monotherapy in 129 patients with follicular lymphoma (n = 83), small lymphocytic lymphoma (n = 28), or marginal zone lymphoma (n = 18) whose disease has progressed and who are refractory to rituximab and to either chemotherapy or radioimmunotherapy.

Among the study’s 129 patients, Duvelisib demonstrated an overall response rate (ORR) of 46%—all of which were partial responses, Infinity acknowledged.

The ORR was 68% among the 28 patients with small lymphocytic lymphoma, the company said, but 41% among the 83 patients with follicular lymphoma, and just 33% among the 18 patients with marginal zone lymphoma. Infinity said it expected to submit data from DYNAMO study for presentation “at an upcoming scientific conference.”

In addition, Infinity and AbbVie also agreed to “pause” the AbbVie-sponsored Phase Ib/II study evaluating duvelisib in combination with venetoclax and are in “ongoing, collaborative discussions” to explore next steps for the parties' up-to-$805 million collaboration, launched in 2014.

“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 stated.

She added that Infinity will meet with the “to determine our next steps with respect to duvelisib” in iNHL.

Infinity said it expects to provide revised 2016 guidance to investors, adding that the company’s earlier guidance “should no longer be relied upon.”

The company previously projected 2016 revenues ranging from $225 million to $245 million, assuming it would receive $200 million in milestone payments under its collaboration with AbbVie, net revenues ranging from $15 million to $35 million, and a year-end cash-and-investments balance of between $45 million and $65 million.

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