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Infinity Provides Company Update And Reports First Quarter 2016 Financial Results

CAMBRIDGE, Mass., May 4, 2016 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. INFI, -3.55% today announced its first quarter 2016 financial results and ongoing progress with its pipeline, including duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an immuno-oncology development candidate that selectively inhibits PI3K-gamma.

Infinity expects to report topline data from DYNAMO™, a registration-focused Phase 2 monotherapy 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 registration-focused Phase 3 monotherapy study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), early 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.

"We believe the next few months will be fundamental to advancing Infinity's goal of bringing important new medicines to patients. If the duvelisib data that we anticipate in the coming months are favorable, these data could enable regulatory filings to be submitted in the U.S. and Europe in the fourth quarter of 2016. Achieving these milestones positions us to potentially bring duvelisib to patients next year," stated Adelene Perkins, president and chief executive officer. "Infinity is also advancing several clinical studies designed to evaluate the safety and activity of duvelisib in broader patient populations. Additionally, our collaborator, AbbVie, has initiated a Phase 1b/2 clinical study of duvelisib in combination with Venclexta," Ms. Perkins continued.

Recent developments:

  • Preliminary data from CONTEMPO to be presented in June: Infinity today announced that preliminary data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, has been accepted for presentation in a poster session at the 21 [st] Congress of European Hematology Association (EHA), which will take place June 9 - 12, 2016, in Copenhagen.
  • Phase 1b/2 study of duvelisib in combination with Venclexta™ initiated: AbbVie has initiated a Phase 1b/2 clinical study of duvelisib in combination with Venclexta, AbbVie's B-cell lymphoma-2 (BCL-2) selective inhibitor. This study is designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with relapsed or refractory iNHL, aggressive NHL, small lymphocytic lymphoma or CLL.
  • Preclinical data for IPI-549 presented at the 2016 American Association for Cancer Research (AACR) Annual Meeting: In April, Infinity researchers in collaboration with researchers at Memorial Sloan Kettering Cancer Center presented preclinical data for IPI-549 at the 2016 AACR Annual Meeting. Preclinical data in multiple solid tumor models demonstrated that IPI-549 targets immune cells and alters the immune-suppressive microenvironment, promoting an anti-tumor immune response that leads to tumor growth inhibition. Data also demonstrated that IPI-549 enhances the effects of checkpoint inhibitors, resulting in improved survival in murine models.

A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

  • Inducement Grant Under NASDAQ Listing Rule 5635(c)(4) : In connection with the appointment of Mr. Christopher Lindblom as vice president, finance and treasurer at Infinity, the Compensation Committee of Infinity's Board of Directors approved the grant of an option to Mr. Lindblom to purchase 40,000 shares of Infinity's common stock. The option was granted outside of the company's equity incentive plans and was made as an inducement material to Mr. Lindblom's acceptance of employment. The option has an exercise price of $5.87 per share, which is equal to the closing price of Infinity's common stock on May 2, 2016. One-fourth of the shares underlying Mr. Lindblom's option will vest on the one year anniversary of his date of hire and thereafter 1/48th of the shares underlying Mr. Lindblom's option will vest monthly, such that the shares underlying the option will be fully vested on the fourth anniversary of his date of hire, subject to his continued employment with Infinity on each such vesting date.

First Quarter 2016 Financial Results

  • At March 31, 2016, Infinity had total cash, cash equivalents and available-for-sale securities of $193.0 million, compared to $245.2...