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Curis Announces Issuance of U.S. Patent Covering CUDC-101 Composition of Matter for Novel HDAC/EGFR/Her2 Inhibitor

Wednesday, June 17, 2009

Cambridge, MA -- Curis, Inc. (Nasdaq: CRIS), a drug development company focused on developing proprietary targeted medicines for cancer treatment, today announced the issuance of U.S. Patent Number 7,547,781, entitled "Quinazoline Based EGFR Inhibitors Containing a Zinc Binding Moiety." The patent covers a genus of compounds that includes CUDC-101, Curis’ HDAC/EGFR/Her2 inhibitor, which is currently in a Phase I clinical trial.

"We believe that the issuance of this U.S. patent recognizes the novelty and inventiveness of Curis’ HDAC/EGFR multi-target inhibitors, including CUDC-101," stated Dan Passeri, Curis’ President and Chief Executive Officer. "Curis is currently seeking to advance several other preclinical multi-targeted compounds that are designed to simultaneously inhibit HDAC and at least one other validated cancer target. We believe that the structural characteristics of the HDAC inhibitory moiety integrated in CUDC-101 will similarly provide novelty to other classes of compounds that we are developing under our broad and proprietary multi-targeted inhibitor programs. These programs are aimed at developing single agent small molecules that target multiple biological pathways, thus providing novel therapies for cancer network disruption. We are hopeful that future patents will issue for several additional classes of these compounds."

About Curis’ Proprietary Targeted Cancer Programs

Through its targeted cancer programs, Curis seeks 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 EGFR, Her2, PI3K, BCR-Abl/Src, and others, 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, which is currently in Phase I clinical testing. Curis also is 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.

In addition, Curis is designing single-targeted drug candidates that it believes demonstrate the potential to achieve best-in-class status among existing single target drugs. Curis’ first such single targeted inhibitor is CUDC-305, an orally available, 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 for cancer indications. 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

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 expectations about the potential benefits of its targeted cancer programs, its patent strategies, including its expectation that additional patents will issue on its proprietary multi-targeted cancer programs and its estimated timeframe for filing an IND for CUDC-305. 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, 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.
  • 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, including with respect to the timing of key regulatory filings such as its planned IND filing for CUDC-305.
  • 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 Quarterly Report on Form 10-Q 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.

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