Infinity Pharmaceuticals, Inc., an innovative biopharmaceutical company dedicated to discovering, developing and delivering best-in-class medicines to people with difficult-to-treat diseases, and AbbVie Inc., a global, research-based biopharmaceutical company, have entered into a global collaboration to develop and commercialize duvelisib (IPI-145), Infinity's oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of patients with cancer.
Duvelisib has shown clinical activity across a broad range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukaemia (CLL). Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMO, a phase 2 study in patients with iNHL, and DUO, a phase 3 study in patients with CLL.
Under the terms of the agreement, Infinity will receive an upfront payment of $275 million and is eligible to receive up to $530 million in additional payments for the achievement of development, regulatory and commercial milestones, including up to $405 million for the achievement of milestones through the first commercial sale of duvelisib. In the US, the companies will jointly commercialize duvelisib and will share equally in any potential profits. Outside the US, AbbVie will be responsible for the conduct and funding of commercialization of duvelisib, and Infinity is eligible to receive tiered double-digit royalties on net product sales.
"We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers," said Michael Severino, AbbVie executive vice president and chief scientific officer. "The addition of duvelisib will complement AbbVie's emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients. We look forward to working with Infinity to bring duvelisib to patients worldwide."
"This collaboration is an important step toward fulfilling Infinity's objective of bringing better treatments to patients and further advances our goal of building a sustainable, fully integrated biotechnology company," stated Adelene Q. Perkins, chair, president and chief executive officer at Infinity. "AbbVie will be a wonderful partner for Infinity, bringing all of the expertise and scale of a successful, well established company, together with the energy, drive, innovation, and nimbleness of a young organization. We look forward to advancing duvelisib through monotherapy studies designed to enable registration and in furthering our shared longer-term vision of combining duvelisib with both current standards of care and novel, targeted therapies.
Development and commercialization activities under the collaboration will be managed through a shared governance structure. In the US, Infinity and AbbVie will jointly commercialize duvelisib, assuming regulatory approval, with Infinity booking sales, and will share equally in any potential profits or losses. Outside the US, AbbVie will be responsible for conducting and funding of any commercialization of duvelisib, and Infinity is eligible to receive tiered royalties on net product sales, with percentages ranging from 23.5 per cent to 30.5 per cent.
For sales of duvelisib in the US, AbbVie and Infinity will share equally the existing royalty obligations to Mundipharma International Corporation Limited/Purdue Pharmaceutical Products L.P., and Infinity will be responsible for these royalty obligations outside of the US. Infinity will also be responsible for the existing royalty obligations to Millennium: The Takeda Oncology Company for sales of duvelisib worldwide.
As part of the strategic collaboration, the companies will share responsibility for the conduct of specific trials specified within an agreed-upon global development plan, with each company leading the development of certain trials within the plan. For the initial global development plan agreed to by the companies, Infinity will fund the trials it conducts and the companies will share equally the funding of trials conducted by AbbVie. The agreement includes plans to launch multiple phase 2 and phase 3 studies of duvelisib in hematologic malignancies over the next several years.
Infinity and AbbVie are developing duvelisib, 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.
In 2013, Infinity launched the DUETTS (Duvelisib Trials in Hematologic Malignancies) programme, a worldwide investigation of duvelisib in blood cancers. As part of the DUETTS programme, patient enrollment is ongoing in DYNAMO, a phase 2 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL) (ClinicalTrials.gov Identifier NCT01882803), and DUO, a phase 3 monotherapy study designed to evaluate the safety and efficacy of duvelisib in patients with relapsed/refractory chronic lymphocytic leukaemia (CLL) (NCT02004522). DYNAMO+R, a phase 3 study of duvelisib in combination with rituximab in patients with previously treated follicular lymphoma (NCT02204982), is expected to start in 2014.
Additionally, a Phase 1 study of duvelisib in patients with advanced blood cancers is ongoing (NCT01476657).