CAMBRIDGE, Mass., June 14, 2017 /PRNewswire/ -- Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing IPI-549, a potentially first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), today announced that management will be participating in the following three upcoming conferences:
About 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 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.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® (nivolumab), a PD-1 immune checkpoint inhibitor, 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. 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). Patients enrolled in these 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. Overall, the study is expected to enroll approximately 175 patients.
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 advancing 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. 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; clinical trial plans regarding IPI-549; plans to participate in conferences; and the company's ability to execute on its strategic plans. 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. For example, there can be no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity's product portfolio or other strategic options Infinity may pursue will result in stock price appreciation. 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 those 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 May 9, 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.
OPDIVO® is a registered trademark of Bristol-Myers Squibb.
1 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3K? is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437–442. 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. 3 www.clinicaltrials.gov, NCT02637531.
Contact: Jaren Madden, 617-453-1336
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- JMP Securities Annual Life Sciences Conference: Infinity will participate in the JMP Securities Annual Life Sciences Conference taking place June 20-21, 2017, in New York City. Management will host one-on-one meetings on Tuesday, June 20. Additionally, Adelene Perkins, Infinity's chief executive officer, will join other biotechnology executives in a company panel presentation entitled "Immuno-Oncology: Novel Approaches" taking place Wednesday, June 21, from 10:00 a.m. – 11:00 a.m. ET. Topics of discussion are expected to include next-generation immuno-oncology therapeutics and the future of combination therapy.
- 2017 Biotechnology Innovation Organization (BIO) International Convention: Infinity will also participate in the 2017 BIO International Convention taking place June 19-22, 2017, in San Diego, CA. Infinity's president, Larry Bloch, M.D., J.D., will join other industry leaders in an educational supersession entitled "The Scientific American WorldView Super Session: Wrapping Up and Looking Forward," taking place on Thursday, June 22, from 1:00 p.m. – 2:15 p.m. PT. The panel will discuss the topics explored during the convention and provide their views on future trends in the industry.
- Precision Lung Cancer: Jeffery Kutok, M.D., Ph.D., chief scientific officer at Infinity, will discuss the preclinical rationale for targeting PI3K-gamma previously reported in two publications in Nature1,2 and summarize previously reported clinical data from the Phase 1 study of IPI-549 in patients with advanced solid tumors during the 2017 Precision: Lung Cancer Conference being held July 25-26, 2017, in Boston, MA. Dr. Kutok's talk, entitled "Reprogramming Tumor-Associated Macrophages by Targeting PI3K-Gamma with IPI-549" will take place on Tuesday, July 25, from 10:00 a.m. – 10:30 a.m. ET. IPI-549 has demonstrated activity in preclinical models of lung cancer, and the expansion phase of the ongoing Phase 1 study of IPI-549 will include an evaluation of IPI-549 in combination with Opdivo® (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with non-small cell lung cancer. IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.
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About 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 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.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® (nivolumab), a PD-1 immune checkpoint inhibitor, 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. 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). Patients enrolled in these 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. Overall, the study is expected to enroll approximately 175 patients.
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 advancing 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. 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; clinical trial plans regarding IPI-549; plans to participate in conferences; and the company's ability to execute on its strategic plans. 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. For example, there can be no guarantee that IPI-549 will successfully complete necessary preclinical and clinical development phases. Further, there can be no guarantee that any positive developments in Infinity's product portfolio or other strategic options Infinity may pursue will result in stock price appreciation. 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 those 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 May 9, 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.
OPDIVO® is a registered trademark of Bristol-Myers Squibb.
1 Kaneda, M., Messer, K., Ralainirina, N., Li, H., et al. PI3K? is a molecular switch that controls immune suppression. Nature, 2016 Nov;539:437–442. 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. 3 www.clinicaltrials.gov, NCT02637531.
Contact: Jaren Madden, 617-453-1336
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SOURCE Infinity Pharmaceuticals, Inc.
