Infinity Pharmaceuticals said today it will eliminate 58% of its workforce—100 employees—and shut down several clinical trials in a restructuring touched off by the end of a nearly 2-year-old collaboration with AbbVie to co-develop the cancer compound duvelisib.
The 100 positions will be eliminated “across the organization” and are expected to be substantially completed by July 15, and fully completed by year’s end, Infinity said in a regulatory filing.
Infinity said it expects to incur severance, benefits, and related costs of approximately $8 million related to the workforce reduction, with future cash outlays of $5 million expected to be paid this year, and up to approximately $3 million expected to be paid during 2017.
The layoffs are the second wave announced by Infinity since reporting underwhelming Phase II results for its lead candidate duvelisib in refractory indolent non-Hodgkin lymphoma. On June 14, Inifinity said it would eliminate 21% of its workforce (46 jobs) by year’s end.
In this latest restructuring, Infinity will shut down its Phase III BRAVURA study of duvelisib in patients with relapsed indolent non-Hodgkin lymphoma, and CONTEMPO, a Phase Ib/II study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will also not proceed with another Phase Ib/II study assessing duvelisib in combination with venetoclax.
The company said it expects clinical trial and related development close down costs to range from $5 million to $7 million, with related cash outlays to be paid this year.
The collaboration ended after the companies could not find a mutually attractive financial structure for continuation of the collaboration following talks about a possible restructuring of the partnership. After those talks concluded on June 24, AbbVie sent notice to Infinity that it was ending the collaboration, effective September 23, Infinity said.
As a result, Infinity has regained worldwide rights to duvelisib, an oral inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma being developed for indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia.
Infinity said it still plans to file an NDA for duvelisib with the FDA in the fourth quarter, using data from both DUO, a randomized, Phase III monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia, and DYNAMO, a single-arm, Phase III monotherapy study in patients with indolent non-Hodgkin lymphoma.
The company said it expects to report topline data from DUO, predicated on the results of an interim analysis, in the third quarter.
Earlier this month, Infinity reported that Duvelisib met its primary endpoint of overall response rate in the DYNAMO™ study, which 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. However, 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.
“Data reported to date have demonstrated that duvelisib is clinically active with a manageable safety profile, and we believe that it could play an important role in the future treatment of patients with hematologic malignancies, particularly for relapsing and/or refractory patients,” Infinity President and CEO Adelene Perkins said in a statement. “We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib.”
Infinity also stated that it is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in chronic lymphocytic leukemia or small lymphocytic lymphoma patients who were previously treated with a Bruton's tyrosine kinase inhibitor, and FRESCO, a combination study in patients with relapsed/refractory follicular lymphoma designed to evaluate the potential of duvelisib to replace chemotherapy.
Infinity plans to discuss with the FDA the potential for FRESCO to serve as a confirmatory study for full approval in follicular lymphoma should duvelisib receive an accelerated approval based on the DYNAMO study, the company said.
Infinity and AbbVie launched their up-to-$805 million collaboration in September 2014, after Infinity positioned itself to buy global rights to the drug about a month earlier from Takeda Pharmaceutical’s Millennium subsidiary.
AbbVie paid Infinity a nonrefundable $275 million upfront payment in 2014 and a $130 million milestone payment in November 2015 associated with the completion of enrollment of DYNAMO, Infinity said in the regulatory filing.