On January 11, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported 2016 anticipated milestones for duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and provided financial guidance for 2016 (Press release, Infinity Pharmaceuticals, JAN 11, 2016, View Source;p=RssLanding&cat=news&id=2128081 [SID:1234508752]). Infinity expects to report topline data from DYNAMO, a Phase 2 study of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), early in the third quarter of 2016. Infinity also anticipates completing an interim analysis of DUO, a Phase 3 study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), in the second half of 2016. The company expects marketing applications, if supported by these data, to be submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the fourth quarter of 2016. These updates were made in conjunction with the 34th Annual J.P. Morgan Healthcare Conference that begins today in San Francisco. Infinity’s chair, president and chief executive officer, Adelene Perkins, will discuss the company’s continued execution of its corporate strategy and 2016 priorities as part of a live presentation on Wednesday, January 13, at 2:00 p.m. PT (5:00 p.m. ET). The presentation will be webcast on Infinity’s website, www.infi.com.
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"In 2016, we are focused on three key strategic objectives designed to bring duvelisib to patients: submitting applications for regulatory approval based on anticipated positive duvelisib data; preparing for the launch of duvelisib together with our partner, AbbVie; and, advancing clinical studies designed to differentiate duvelisib, with the ultimate aspiration of offering a potential cure to patients with hematologic malignancies," said Ms. Perkins.
The Phase 1b/2 clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor, is expected to begin this month. This study is designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with relapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHL.
"The fourth strategic objective for Infinity is to advance our second development candidate, IPI-549, and we are pleased to announce the Phase 1 study is now under way," Ms. Perkins continued. "IPI-549 represents an important extension of our oncology portfolio to include development candidates directed at both hematologic malignancies and solid tumors."
2016 Duvelisib Goals
Infinity expects to achieve the following duvelisib milestones in 2016:
Report topline DYNAMO data in 3Q16
Report topline DUO data in 2H16*
Submit a New Drug Application (NDA) for iNHL and CLL in 4Q16*
AbbVie submission of Marketing Authorization Application (MAA) for follicular lymphoma and CLL in 4Q16*
Report initial data from CONTEMPO, a Phase1b/2 study in treatment-naïve patients with follicular lymphoma, in 2H16
Advance Phase 1b/2 study of duvelisib in combination with venetoclax
*CLL NDA filing and follicular lymphoma/CLL MAA filing predicated on DUO interim analysis.
2016 Financial Guidance
Infinity ended 2015 with approximately $245 million in cash and investments (unaudited) and plans to report its fourth quarter and full-year 2015 financial results in late February. The company is providing the following guidance today with respect to its 2016
financial outlook:
Revenue: Infinity expects revenue for 2016 to range from $225 million to $245 million, assuming the achievement of $200 million in anticipated regulatory milestones under the company’s collaboration with AbbVie: $125 million associated with the acceptance of the first NDA submission and $75 million associated with the acceptance of the first MAA submission, both expected in the fourth quarter of 2016.
Net Income: Infinity expects net income for 2016 to range from $15 million to $35 million.
Cash and Investments: Infinity expects to end 2016 with a year-end cash and investments balance ranging from $45 million to $65 million. The company expects to earn $200 million in regulatory milestones, as noted above, in the fourth quarter of 2016 with payment by AbbVie anticipated in the first quarter of 2017.
About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.[i] Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.[ii] Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.
Infinity and AbbVie are conducting a broad clinical development program evaluating duvelisib in patients with hematologic malignancies. In addition to DYNAMO and DUO, ongoing studies include BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. AbbVie is also conducting a clinical study in duvelisib in combination with venetoclax in patients with relapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHL, as well as a Phase 1 study of duvelisib in Japanese subjects with relapsed or refractory lymphoma. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.
Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.