Curis Presents Preclinical Data on CU-906 at AACR 101st Annual Meeting 2010

- Poster presentation highlights data on drug candidate from first-in-class series of compounds targeting HDAC and PI3K/mTOR kinases -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 21, 2010 - Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that data provided in a presentation entitled, “Antitumor activity of single small molecule agent targeting PI3K/mTor and HDAC,” were presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010, which is being held in Washington, DC April 17-21. The poster highlights data on the Company's novel research compound CU-906, which is designed to inhibit HDAC and PI3K/mTOR targets simultaneously. This presentation was given during a poster session on April 20th by Rudi Bao, M.D., Ph.D., Curis' Senior Director of Oncology.

“It has been widely published that the activation of the PI3K-mTOR and related Akt signaling pathways play a crucial role in cancer development and progression, and inhibition of these pathways have recently been investigated extensively as a cancer therapy,” stated Dan Passeri, Curis President and Chief Executive Officer. “However, the efficacy of the PI3K pathway inhibition is limited by the release of negative feedback loops, resulting in the activation of alternate pathways such as the RAF-MEK-ERK pathway. In an effort to enhance anti-tumor activity and overcome these limitations, we have developed a series of small-molecule compounds that are able to simultaneously inhibit both PI3K/mTOR and HDAC, an epigenetic cancer target, based the synergistic effects of inhibition of these targets in cancer cells. We expect to select CU-906 or another molecule from this class of compounds as a development candidate in 2010.”

About CU-906

CU-906 is a multi-targeted molecule that is designed to inhibit HDAC and PI3K and mTOR kinases, the combination of which Curis scientists believe have synergistic interaction against cancer cells. In vitro mechanism of action studies demonstrated that CU-906 is able to inhibit Class I PI3K and mTOR kinases, suppress multiple nodes of other survival pathways including the RAF-MEK-ERK pathway, and upregulate P21, which is a cyclin-dependent kinase inhibitor that can promote cancer cell death when upregulated. The suppression of non-PI3K-AKT-mTOR survival pathways occurs via epigenetic modification as a result of the inhibition of HDAC, the non-kinase target of CU-906. By contrast, single-target PI3K inhibitors and PI3K/mTor dual inhibitors that only target the primary PI3K and/or mTOR kinase survival pathways, have only been shown to have limited effects on tumors with disregulation of other signaling pathways.

CU-906 exhibits anti-proliferation activity against a broad range of cancer cell types in in vitro studies, including cell lines that are insensitive to PI3K inhibitors. CU-906's anti-proliferation activity is up to 100 times more potent than that of two leading PI3K inhibitors in development. Efficacy studies in various K-RAS mutant tumor xenograft models indicate that this compound has more potent antitumor activity than a leading PI3K inhibitor that is currently in clinical development, at doses causing no obvious side effects to the tumor-bearing animals.

Importantly, CU-906 displays high exposure and long half-life in tumor tissue after IV administration and is orally bioavailable in preclinical models. CU-906 has a half-life of more than 10 hours in xenograft tumors, induces apoptosis and inhibits cell proliferation up to 48 hours following a single dose of the compound to tumor-bearing animals.

About Curis, Inc.

Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. In expanding its drug development efforts in the field of cancer through its proprietary targeted cancer programs, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.

Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation the Company's belief that CU-906 will provide benefit that is superior to current PI3K and PI3K/mTOR drug candidates as well as its estimate of the period in which it will select an additional development candidate from this class of compounds. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause the actual results to be materially different from those indicated by such forward-looking statements including, among other things:

 

  • Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its Phase I clinical trial of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
  • Genentech and Roche and Debiopharm may experience adverse results, delays and/or failures in their respective development programs under collaboration with Curis. For example, Genentech may not be able to replicate in later trials any favorable outcomes from earlier trials of GDC-0449, and Debiopharm may not be able to successfully advance Debio 0932 into clinical trials as planned.
  • Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
  • Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
  • Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
  • Curis may experience unplanned cash requirements, and may not receive additional anticipated payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis' estimated operating expenses for 2010 and beyond.
  • Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech and Debiopharm, and the risk that any such collaborators will not perform adequately.
  • Curis also faces other risk factors identified in its Annual Report on Form 10-K for the year ended December 31, 2009 and other filings that it periodically makes with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.

Contact: Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial and Chief Operating Officer
mgray@curis.com

 

Posted: April 2010

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