Curis Presents Preclinical Data for CU-903 at Keystone Symposia Event “PI3 Kinase Signaling in Disease”

- Novel small molecule inhibitor of histone deacetylase (HDAC) and phosphatidylinositol-3-kinase (PI3K) demonstrates potent anti-cancer activity in pre-clinical cancer models -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 27, 2009 - Curis, Inc. (NASDAQ: CRIS), a drug development company focused on developing proprietary targeted medicines for cancer treatment, today announced that an oral presentation entitled, "A Single Small Molecule That Inhibits Histone Deacetylase and Phosphatidylinositol-3-Kinase," was presented at the “PI-3 Kinase Signaling in Disease” Keystone Symposia event, which is being held in Olympic Valley, California, April 22-27.

“CU-903 is potentially a first-in-class multi-targeted inhibitor of key oncogenic pathways and we believe this compound represents a unique and rational approach to attack the tumor cell signaling network,” stated Dan Passeri, President and Chief Executive Officer. “We believe that CU-903 is an example of the potential depth of our targeted cancer pipeline and we are encouraged by the initial results of our preclinical studies on this compound. We look forward to continuing our efforts to progress CU-903 and anticipate providing updates for this molecule in the coming months.”

Aberrant activation of the PI3K pathway is often seen in human cancers. Therefore, PI3K has become an attractive target for cancer therapy. However, as seen in clinical use of other molecularly targeted agents, the effectiveness of a single-target agent is often hindered by poor response rates and acquired drug resistance. In an effort to overcome these limitations, Curis scientists have combined PI3K and HDAC inhibitory activities into a single small molecule, CU-903. To support the rationale behind this synthetic design, preclinical data was generated demonstrating that the combination of HDAC and PI3K inhibition is synergistic. The presentation also suggests that CU-903's integrated HDAC/PI3K inhibitory activities provide the molecule with the potential to overcome the limitations in the treatment of heterogeneous and drug-resistant tumors with conventional single-target PI3K inhibitors.

The presentation highlighted data wherein CU-903 inhibited HDAC to induce the levels of tumor suppressors, as well as to simultaneously suppress the PI3K activity. CU-903 consistently displayed strong anti-proliferation effects in breast, colon, melanoma and non-small cell lung cancer cell lines. In addition, CU-903 is distinguished by its ability to suppress the protein levels of receptor tyrosine kinases and key regulators of MAP kinase signaling, which often contribute to cancer cell growth and are unaffected when treated with single-target PI3K inhibitors in Curis' preclinical studies. The Company plans to continue pre-clinical evaluation of CU-903 in further studies.

About Curis' Proprietary Targeted Cancer Programs

Curis' targeted cancer programs seek to rationally design and develop novel, proprietary small molecules that target one or more targets or pathways known to play key roles in the development or maintenance of cancer. Curis has generated single agent, multi-target small molecules that are being designed to combine HDAC inhibition with suppression of targets including among others EGFR, Her2, PI3K and BCR-Abl/Src, with a goal of potentially providing enhanced efficacy over existing drugs. The first development candidate selected from this multi-target program is CUDC-101, a first-in-class small molecule designed to inhibit HDAC, EGFR and Her2, that is currently in Phase I clinical testing. Curis is also conducting preclinical studies on several other classes of multi-targeted inhibitors including among others CU-903, an HDAC/PI3K inhibitor and CU-201, an HDAC/BCR-Abl/Src inhibitor.

Curis is also designing single-targeted drug candidates that it believes have the potential to achieve best-in-class status among existing single target drugs. The first such single targeted inhibitor is CUDC-305, an orally available, wholly-synthetic small molecule inhibitor of heat shock protein 90 (Hsp90). Curis expects to file an IND for CUDC-305 in mid-2009.

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 medicines, primarily for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer drug development platform, 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.

Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation: statements regarding management's expectation that it will continue to advance CU-903 in further preclinical studies. 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 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.  
  • Curis' collaborator, Genentech, may experience adverse results, delays and/or failures in the Hedgehog pathway inhibitor program currently under clinical development.  
  • Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaboration with Genentech.  
  • 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 additional funding required to conduct research and development of its drug candidates.  
  • Curis may experience unplanned cash requirements and expenditures which, among other things, 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 2009 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 the risk that any such collaborators will not perform adequately.  
  • Curis also faces other risk factors identified in its most recent Annual Report on Form 10-K 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

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Posted: April 2009

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