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IPI-549 Featured at 15th International Congress on Targeted Anticancer Therapies

PARIS, March 6, 2017 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that Phase 1 clinical data for IPI-549, an orally administered immuno-oncology development candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), were presented during a plenary session at the 15th International Congress on Targeted Anticancer Therapies (TAT 2017) taking place in Paris, France, March 6 – 8. A Phase 1 clinical study is ongoing to explore the safety and activity of IPI-549 both as a monotherapy and in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors. IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.

"The TAT congress has become a leading conference for Phase 1 clinical studies in oncology, so it is an honor to be invited to participate in a plenary session to discuss our progress with IPI-549 at this year's congress," commented Claudio Dansky Ullmann, M.D., senior vice president, clinical development at Infinity.

Today's presentation at TAT 2017 included updated Phase 1 data from 12 patients enrolled in the monotherapy dose-escalation phase of the ongoing study. The presentation, "A Phase 1/1b, First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor and Myeloid Targeting Agent, as Monotherapy and in Combination with Nivolumab in Patients with Advanced Solid Tumors," was given by Anthony Tolcher, M.D., FRCP(C), clinical director at South Texas Accelerated Research Therapeutics, an investigator for the Phase 1 study and the recipient of the TAT 2016 Honorary Award Invited Lecture.

"Based on the experience of patients in my clinic, I am encouraged about the potential of IPI-549, and the data to date suggest that the safety, pharmacokinetics and pharmacodynamics of monotherapy treatment appear favorable," stated Dr. Tolcher. "IPI-549 holds the promise of offering a unique approach for enhancing the body's anti-tumor immune response, and I look forward to continuing to participate in this Phase 1 clinical study."

Additionally, IPI-549 was discussed today during the TAT 2017 Honorary Award Invited Lecture, "Immunologic Checkpoint Blockade: Exploring Combinations and Mechanisms," which was given by Jedd Wolchok, M.D., Ph.D., Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK), as well as Associate Director of the Ludwig Center for Cancer Immunotherapy and Director of the Parker Institute for Cancer Immunotherapy, both at MSK. Dr. Wolchok serves as the lead investigator for the Phase 1 clinical study of IPI-549. He is also an author on the recently published Nature paper which described that the presence of suppressive myeloid cells is critical in tumor resistance to checkpoint inhibitors and targeting PI3K-gamma in these cells with IPI-549 is able to help overcome this resistance.1

"This is an exciting time in the field of immuno-oncology. New immunotherapies, such as checkpoint inhibitors, underscore the progress we have made in the treatment of various cancers. Even so, we are always exploring new avenues of investigation that we hope will benefit even more patients," stated Dr. Wolchok. "IPI-549 is one of the newer and potentially promising immunotherapies in clinical development. Our research suggests IPI-549 could offer a unique way to both enhance the activity of checkpoint inhibition in sensitive tumors, as well as to overcome tumor resistance to checkpoint inhibition."

IPI-549 Poster Presentation at Upcoming AACR Annual Meeting 2017
Last week, Infinity announced that updated Phase 1 data for IPI-549 will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 taking place in Washington, D.C. April 1 – 5. Details of the presentation are as follows:
Poster presentation time: Tuesday, April 4, 2017, 8:00 a.m. – 12:00 p.m. ET 
Title: IPI-549-01 - A Phase 1/1b, First-in-Human Study of IPI-549, a PI3K-Gamma Inhibitor, as Monotherapy and in Combination with Nivolumab in Patients with Advanced Solid Tumors
Abstract number: CT089
Lead author: Jedd Wolchok, M.D., Ph.D., Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center (MSK), as well as Associate Director of the Ludwig Center for Cancer Immunotherapy and Director of the Parker Institute for Cancer Immunotherapy, both at MSK
Location: Convention Center, Halls A-C, Poster Section 33 

Due to AACR embargo policies, the data presented today at TAT 2017 will be made available during the AACR Annual Meeting 2017.

About the IPI-549 and the Ongoing Phase 1 Study 
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 increases antitumor immunity by targeting tumor-associated myeloid cells and overcomes immune checkpoint blockade resistance in preclinical tumor models.1,2 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.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo® in patients with advanced solid tumors.3 The study includes monotherapy and combination dose-escalation phases, in addition to a monotherapy expansion cohort and combination expansion cohorts. Overall, the study is expected to enroll approximately 175 patients.

The expansion cohorts evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). There is a great need for additional treatment options for the growing number of patients living with these types of cancers, which account for more than 17 percent of all new cancer cases in the U.S.4,5 Additionally, patients enrolled in the combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study.  

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

About Infinity
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is developing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study in patients with advanced solid tumors is ongoing. For more information on Infinity, please refer to Infinity's website at www.infi.com.

Cautionary Note Regarding Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 including those regarding the company's expectations about the timing and type of data presentations, the therapeutic potential of PI3K-gamma inhibition and of IPI-549, alone or in combination with other agents, and clinical trial plans regarding IPI-549. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations, including, for example, that there is no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases, or gain regulatory approval, and other risks described in greater detail under the caption "Risk Factors" included in Infinity's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2016, and other filings filed by Infinity with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

OPDIVO® is a registered trademark of Bristol-Myers Squibb.

Contact:
Jaren Irene Madden, Senior Director, Investor Relations and Corporate Communications
617-453-1336 or Jaren.Madden@infi.com

1 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade therapy by targeting PI3Kγ in myeloid cells. Nature, 2016 Nov;539:443-447.

2 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3Kγ is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437–442.  

3 www.clinicaltrials.gov, NCT02637531.

4 American Cancer Society, Cancer Facts and Statistics 2016, http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index and http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics, Last Accessed March 2, 2017.

5 Conquer Cancer Foundation, Head and Neck Cancer Statistics, http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics, Last Accessed March 2, 2017.

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SOURCE Infinity Pharmaceuticals, Inc.