Infinity Pharma And Bristol-Myers Squibb Expand Clinical Collaboration Evaluating IPI-549 In Combination With Opdivo (Nivolumab)

Published: Sep 25, 2017

- Collaboration Expands Ongoing Phase 1/1b Study to Include Patients with Triple Negative Breast Cancer Who Have Not Been Previously Exposed to Anti-PD-1 or Anti-PD-L1 Therapy -

CAMBRIDGE, Mass., Sept. 25, 2017 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced that it has expanded its existing clinical collaboration with Bristol-Myers Squibb evaluating IPI-549 in combination with Opdivo® to include patients with triple negative breast cancer (TNBC) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. IPI-549 is an oral, selective phosphoinositide-3-kinase gamma (PI3K-gamma) inhibitor which targets immune-suppressive tumor macrophages, and Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. IPI-549 is currently being evaluated in a Phase 1/1b clinical study in patients with advanced solid tumors and is believed to be the only selective PI3K-gamma inhibitor in clinical development.

Preclinical data have demonstrated that M2, or pro-tumor, macrophages are associated with resistance to checkpoint inhibitor monotherapy, and treatment with IPI-549 in combination with checkpoint inhibitors can overcome this resistance by reprogramming macrophages from the M2 phenotype to the M1, or anti-tumor, phenotype.1,2 A component of this ongoing Phase 1/1b study is designed to explore the potential of combining these two agents to overcome resistance in patients previously treated with checkpoint inhibition. The addition of a cohort of patients with TNBC who have not previously received anti-PD-1 or anti- PD-L1 therapy provides an important opportunity to explore the potential of the combination of IPI-549 and Opdivo to improve efficacy for patients with a type of cancer where there is limited benefit from monotherapy treatment with checkpoint inhibitors.

"The expansion of our ongoing clinical study of IPI-549 and our clinical collaboration with Bristol-Myers Squibb represents an important component of our strategy to bring better treatment options to patients," stated Adelene Perkins, chief executive officer at Infinity. "Particularly, expanding our study to include patients with triple negative breast cancer who have not been previously treated with a PD-1 or PD-L1 immune checkpoint inhibitor allows us to evaluate whether IPI-549 in combination with Opdivo can increase the number of patients who respond to checkpoint inhibition. To date, very few patients with triple negative breast cancer respond to checkpoint inhibitors alone, leaving these patients with very limited therapeutic options."

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin in the second half of 2017.

The combination expansion component includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion component will now also add a cohort of patients with TNBC who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

About IPI-549
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.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. 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 Pharmaceuticals, Inc.
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 1/1b study in patients with advanced solid tumors is ongoing.3 For more information on Infinity, please refer to Infinity's website at www.infi.com.

Infinity's 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. Such forward-looking statements include those regarding: the therapeutic potential of PI3K-gamma selective inhibition and IPI-549, alone and in combination with checkpoint inhibitors, including Opdivo; 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 Infinity's current expectations. For example, there can be no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases, or that development of any of Infinity's product candidates will continue. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Infinity's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities; the failure of Infinity or Bristol-Myers Squibb to perform under their clinical supply collaboration agreement; Infinity's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of agents by Infinity's competitors for diseases in which Infinity is currently developing or intends to develop IPI-549; and Infinity's ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management's expectations are described in greater detail under the caption "Risk Factors" included in Infinity's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, 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.

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

1 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3K is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437442.
2 De Henau, O., Rausch, M., Winkler, D., Campesato, L., et al. Overcoming resistance to checkpoint blockade therapy by targeting PI3K in myeloid cells. Nature, 2016 Nov;539:443-447.
3www.clinicaltrials.gov, NCT02637531.
4 American Cancer Society, Cancer Facts and Statistics 2017, http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/index and http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-key-statistics, Last Accessed September 22, 2017.
5 Conquer Cancer Foundation, Head and Neck Cancer Statistics, http://www.cancer.net/cancer-types/head-and-neck-cancer/statistics, Last Accessed September 22, 2017.

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SOURCE Infinity Pharmaceuticals, Inc.

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