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|Infinity Provides Key 2013 Goals and Financial Guidance|
– Additional Data from Phase 1 Trial of IPI-145 in Hematologic Malignancies Anticipated in 2013 –
– Expands PI3K Franchise with New Product Candidate –
– Strong Financial Position with Cash Runway into 2015 –
– Company to Present at JPMorgan Annual Healthcare Conference at
“Our pipeline, experienced leadership team and financial position
provide the foundation from which we are poised to execute our product
development and business strategy as we continue to build a fully
integrated biopharmaceutical company,” stated
Pipeline Expanded with IPI-443, a Potent PI3K-Delta,Gamma Inhibitor
Infinity today also announced its second potent, oral PI3K-delta,gamma inhibitor, IPI-443. Nonclinical studies of IPI-443 are now under way, which are designed to enable the initiation of Phase 1 clinical development.
“PI3K inhibition has therapeutic potential across both hematologic
malignancies and inflammatory diseases,” stated
2013 Program Goals
Infinity is developing a portfolio of PI3K inhibitors which includes IPI-145 and IPI-443, potent, oral inhibitors of PI3K-delta and PI3K-gamma, as well as retaspimycin hydrochloride (HCl), a potent and selective Hsp90 inhibitor. Infinity anticipates achieving the following development milestones in 2013:
IPI-145 in Hematologic Malignancies
IPI-145 in Inflammation
PI3K Pipeline Expansion
Retaspimycin HCl in NSCLC
2013 Financial Guidance
Infinity entered 2013 with approximately
Infinity to Present at
Infinity will present at the
About Infinity’s PI3K Program
IPI-145 and IPI-443 are potent, oral inhibitors of Class I phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity believes IPI-145 is the most advanced PI3K-delta,gamma inhibitor in clinical development. The PI3Ks are a family of enzymes involved in multiple cellular functions, including cell proliferation and survival, cell differentiation, cell migration and immunity.i The PI3K-delta and PI3K-gamma isoforms are preferentially expressed in leukocytes, where they have distinct and non-overlapping roles in immune cell development and function. Targeting PI3K-delta and PI3K-gamma may provide multiple opportunities to develop differentiated therapies for the treatment of inflammatory diseases as well as hematologic malignancies.
IPI-145 is currently progressing in a Phase 1 trial in patients with advanced hematologic malignancies. Preliminary data from this trial showed that IPI-145 was well tolerated to date and clinically active in patients with both B-cell and T-cell malignancies, including chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma, mantle cell lymphoma, Hodgkin’s lymphoma and T-cell lymphoma.ii Infinity is also conducting a Phase 2a trial in patients with mild, allergic asthma and is planning to begin a Phase 2 trial of IPI-145 in patients with rheumatoid arthritis in the first half of 2013.
About Infinity’s Hsp90 Program
Retaspimycin HCl is an intravenously administered, potent and selective heat shock protein 90 (Hsp90) inhibitor. The Hsp90 chaperone plays a key role in regulating the stability of its client proteins.iii Cancer cells express elevated levels of Hsp90 relative to normal cells and depend on Hsp90 to support certain oncoproteins and to buffer cellular stresses induced by malignant transformation.iii,iv Thus, Hsp90 is a fundamental hub in protein interaction networks, maintaining the functional state of many proteins critical for cancer growth, proliferation and survival.iii,v Inhibition of Hsp90 has the potential to shut down multiple oncogenic signaling pathways simultaneously.iv
Infinity has completed patient enrollment in a double-blind, randomized, placebo-controlled Phase 2 trial designed to evaluate the anti-tumor activity, tolerability and safety of retaspimycin HCl in combination with docetaxel compared to docetaxel alone in patients with second- or third-line non-small cell lung cancer (NSCLC) who are naïve to docetaxel treatment and have a smoking history. This study is supported by data from a Phase 1b trial in which retaspimycin HCl in combination with docetaxel was well tolerated and clinically active in heavily pretreated patients with NSCLC.vi A Phase 1b/2 trial of retaspimycin HCl in combination with everolimus in NSCLC patients with a KRAS mutation is also ongoing.
Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs focused on the inhibition of phosphoinositide-3-kinase and heat shock protein 90 are evidence of its innovative approach to drug discovery and development.
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 Company’s
expectations about: the timing of data from clinical trials of its PI3K
and Hsp90 programs; its ability to execute on its strategic plans; its
current cash position; the therapeutic potential of its PI3K inhibitors
and retaspimycin HCl; its 2013 research and development goals, including
without limitation clinical development plans, for its PI3K program and
its Hsp90 program; and its financial guidance for 2013 with respect to
operating expenses, net loss and cash and investments. 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 Infinity will report data in the time frames it has estimated, that
any product candidate Infinity is developing will successfully complete
necessary preclinical and clinical development phases or that
development of any of Infinity’s product candidates will continue.
Further, there can be no guarantee that any positive developments in
Infinity’s product portfolio 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 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.
i Weinberg RA (2007) Cytoplasmic signaling circuitry programs
many of the traits of cancer. In Jeffcock E, Zayatz E, and Mickey RK
(Eds.) The biology of cancer (pp. 179-183).
ii Flinn, I.W., Horwitz, S.M., Patel, M., Younes, A., Porter,
J., Sweeney, J., Allen, K., Kelly, P., Kahl, B. Clinical Safety and
Activity in a Phase 1 Trial of IPI-145, a Potent Inhibitor of
Phosphoinositide-3-Kinase-(δ,γ) in Patients with Advanced Hematologic
Malignancies. Poster presented at the 54th Annual Meeting of the
iii Whitesell L and Lindquist SL. Hsp90 and the chaperoning of cancer. Nat Rev Cancer 2005, 5(10):761-772.
iv Workman P, Burrows F, Neckers L, Rosen N. Drugging the cancer chaperone Hsp90: Combinatorial therapeutic exploitation of oncogene addiction and tumor stress. Ann NY Acad Sci 2007, 1113:202-216.
v Taipale M, Jarosz DF, Lindquist S. Hsp90 at hub of protein homeostasis: Emerging mechanistic insights. Nat Rev Mol Cell Bio 2010, 11:515-528.
vi Riely GJ, Gettinger SN, Stoller RG, Gabrail NY, Weiss GJ,
Tunkey C, et al. Safety and activity of IPI-504 (restaspimycin HCl) and
docetaxel in pretreated patients with metastatic non-small cell lung
cancer (NSCLC). Poster presented at the 47th Annual Meeting of the