Date: 2016-06-08
Type of information: Termination of the agreement
Compound: duvelisib (IPI-145)
Company: Abbvie (USA - IL) Infinity Pharmaceuticals (USA - MA)
Therapeutic area: Cancer - Oncology
Type agreement: development commercialisation
Action mechanism: phosphoinositide 3-kinase (PI3K) inhibitor. Duvelisib is an oral inhibitor of Class I PI3K-delta,gamma. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity. The PI3K-delta,gamma isoforms are preferentially expressed in leukocytes (white blood cells), where they have distinct and mostly non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of hematologic malignancies.
Disease:
Details: * On June 28, 2016, Infinity Pharmaceuticals announced that AbbVie has exercised its right to end its collaboration with Infinity to develop and commercialize duvelisib. The companies had been in discussions regarding a potential restructuring of the partnership but were unable to find a mutually attractive financial structure for continuation of the collaboration. With the termination of this agreement, Infinity has regained worldwide rights to duvelisib and neither Infinity nor AbbVie have future financial obligations to the other party. In parallel with exploring strategic options for the duvelisib program, Infinity is continuing to focus on filing a new drug application (NDA) for duvelisib with the FDA in the fourth quarter of 2016. The company's filing strategy includes the incorporation of data from both DUO, a randomized, Phase 3 monotherapy study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL). Earlier this month, Infinity reported that the DYNAMO study met its primary endpoint of overall response rate and that duvelisib demonstrated a manageable safety profile in the enrolled patient population. Infinity plans to seek feedback on the DYNAMO data from the FDA. Infinity also expects to report topline data from DUO, predicated on the results of an interim analysis, in the third quarter of 2016. At this time, Infinity is continuing to focus resources on the DYNAMO and DUO studies, as well as SYNCHRONY, a combination study of duvelisib plus obinutuzumab in CLL or small lymphocytic lymphoma patients who were previously treated with a Bruton's tyrosine kinase (BTK) 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. Infinity will also reduce its workforce by 58 percent, impacting 100 of Infinity's team members in order to align corporate resources with the company's strategic decisions which include closing BRAVURA, a Phase 3 study of duvelisib in patients with relapsed iNHL, and CONTEMPO, a Phase 1b/2 study of duvelisib in treatment-naïve patients with follicular lymphoma. Infinity will not proceed with the Phase 1b/2 study of duvelisib in combination with venetoclax.
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