Verastem has acquired exclusive worldwide rights to develop and commercialize Infinity Pharmaceuticals' Phase III oncology product candidate duvelisib, under a license agreement that could generate up to $28 million-plus for Infinity.
Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma under study in the Phase III DUO® trial assessing duvelisib as a monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Topline data from DUO is expected in the first half of 2017.
In addition to CLL, duvelisib is under development for other blood cancers that include indolent non-Hodgkin lymphoma (iNHL) and T-cell lymphomas.
“Duvelisib complements Verastem's oncology pipeline by augmenting our strategic focus of developing small-molecule agents that target malignant cells both directly and through modulation of the tumor microenvironment,” Verastem President and CEO Robert Forrester said in a statement. “This transaction represents a positive step toward our goal of bringing new treatment options to patients with cancer.”
Verastem agreed to pay Infinity up to $28 million tied to achieving milestones. Two potential milestone payments are planned: $6 million based on positive data from the DUO study, and $22 million based upon the first regulatory approval inside or outside of the U.S.
Verastem also agreed to pay Infinity tiered mid-to-high single-digit royalties on net sales and will be responsible for the single-digit-royalty on net sales of duvelisib owed by Infinity to Mundipharma International and Purdue Pharmaceutical Products.
“The license of duvelisib fulfills an important strategic goal for Infinity by preserving cash while enabling our shareholders to participate in the value of the duvelisib program through potential milestone payments and royalties to Infinity,” added Adelene Perkins, Infinity’s president and CEO.
In addition to duvelisib, Verastem also holds worldwide rights to the tumor microenvironment-targeting focal adhesion kinase (FAK) inhibitors defactinib (VS-6063) and VS-4718.
Defactinib, which is Verastem's lead FAK inhibitor, is now under study in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic, ovarian, non-small-cell lung cancer, and mesothelioma. These studies are combination clinical trials with Merck & Co.’s Keytruda® (pembrolizumab) or avelumab, which is being developed by Pfizer and Merck KGaA.
Verastem also owns rights to the FAK inhibitor VS-4718 and the dual PI3K and mTORC1/2 inhibitor VS-5584, both of which are the subject of Phase I studies.
