June 28, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Massachusetts - Infinity Pharmaceuticals announced today that North Chicago-based AbbVie chose to terminate its collaboration deal to develop and commercialize duvelisib. Duvelisib is a dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, which are associated with malignant B-cells.
On June 14, Infinity announced the results of its Phase II DYNAMO trial to evaluate duvelisib in refractory indolent non-Hodgkin lymphoma (iNHL). The drug met its primary endpoint of overall response rate (ORR), showing an ORR of 46 percent among 129 patients. Most of the drug’s side effects were reversible and manageable.
“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, a difficult-to-treat disease,” said Adelene Perkins, Infinity’s president and chief executive officer, in a statement at the time. “We plan to seek feedback from the U.S. Food and Drug Administration to determine our next steps with respect to duvelisib in indolent non-Hodgkin lymphoma.”
In the same announcement, Infinity indicated its ongoing deal with AbbVie was going to pause its Phase Ib/II study of duvelisib in combination with venetoclax. At that time it was going to begin “a strategic restructuring that will close down its discovery research organization, impacting 46 members of the Infinity team, or 21 percent of the workforce.”
Today’s announcement more than doubles that number, indicating the company plans to cut its workforce by 58 percent, essentially laying off 100 people. In addition to the DYNAMO study, it will be shuttering BRAVURA, a Phase III trial of duvelisib in relapsed iNHL, and CONTEMPO, a Phase Ib/II trial of duvelisib in treatment-naïve patients with follicular lymphoma.
“We have incredibly talented and dedicated Citizen-Owners at Infinity, and I would like to personally express my gratitude and appreciation for all of their hard work and contributions,” said Perkins in a statement. “The decisions we have made are difficult but necessary to enable a path forward for duvelisib and IPI-549, our second development program. The team we have in place is deeply committed to exploring strategic opportunities for duvelisib, and ultimately IPI-549, to bring benefit to patients.”
IPI-549 is an oral immuno-oncology products that selectively inhibits PI3K-gamma. It has the potential to treat various solid tumors and, according to Infinity, “represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.”
Infinity regains all worldwide rights to duvelisib as part of the termination. “Our partnership with AbbVie and the significant, previously disclosed, funding was critical to our advancement of duvelisib through registration-focused clinical studies in indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia,” said Perkins in a statement. “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. We are now exploring strategic options for the program that could enable the submission of global regulatory applications and commercialization for duvelisib.”
Infinity also plans to continue to file a new drug application (NDA) for duvelisib with the FDA in the fourth quarter of this year. It will include data from DUO, a Phase III monotherapy trial in relapsed/refractory chronic lymphocytic leukemia (CLL), and the DYNAMO trial. It will also focus on SYNCHRONY, a combination study of duvelisib with obinutuzumab in CLL or small lyphocytic lymphoma patients previouisly treated with a Bruton’s tyrosine kinase (BTK) inhibitor, and FRESCO. FRESCO is a combination study in patients with relapsed/refractory follicular lyphoma.
The company also plans to report topline data from DUO in the third quarter of this year.
