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Curis Publishes Preclinical CUDC-101 Data in Cancer Research

- Paper Highlights Curis' Novel, First-in-Class Cancer Drug that Selectively and Simultaneously Targets HDAC, EGFR and Her2 -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 22, 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 a research paper describing the biological activity of its HDAC, EGFR and HER2 inhibitor, CUDC-101, was published online in the journal Cancer Research and also will be published in an upcoming print version of the journal.

“We believe that the results described in this publication demonstrate that CUDC-101 may have the potential to increase patient response rates in certain cancers and improve the treatment of drug-resistant tumors that cannot be effectively controlled with single-target EGFR or Her2 inhibitors,” stated Dan Passeri, Curis' President and Chief Executive Officer. “CUDC-101 represents the first example of an individual small molecule from our network-targeted cancer drug programs that simultaneously inhibits multiple distinct cancer targets chosen for their mechanistic synergy and ability to durably suppress cancer pathway networks. Our scientists plan to select another development candidate mid-year, which they have designed to simultaneously inhibit HDAC and PI3 kinase targets.”

Following Curis' first publication of related to this molecule in the Journal of Medicinal Chemistry earlier this year, the Cancer Research publication describes preclinical data that are supportive of CUDC-101's effective and selective inhibition of HDAC, EGFR and HER2, the direct molecular targets of CUDC-101. The paper also presents data demonstrating that CUDC-101 inhibits key regulators of the EGFR and HER2 signaling pathways, including Akt. Additionally, the drug appears to effectively attenuate HER3 and MET signaling, which are often activated as a compensatory mechanism in response to EGFR and HER2 inhibition and are believed to help cancer cells escape the effects of conventional EGFR and HER2 inhibitors. CUDC-101 suppresses the progression of and induces cell death of a broad range of tumor types at low doses in in vitro and in vivo preclinical cancer models, including certain cancer cells that are resistant to approved standard-of-care single-target agents.

The paper also indicates that CUDC-101 achieves a synergistic effect through simultaneous inhibition of HDAC, EGFR and HER2 targets. The authors tested the growth-inhibitory activity of CUDC-101 in a total of 54 human cancer cell lines, with results showing that the compound effectively inhibits growth of a broad range of cancer cell types, including lung, pancreas, liver, colon, breast, prostate and head and neck. Notably, CUDC-101 exhibited equal or greater potency in these assays than vorinostat (a marketed HDAC inhibitor), erlotinib (a marketed EGFR inhibitor), lapatinib (a marketed EGFR/HER2 inhibitor) and combinations of vorinostat and erlotinib and vorinostat and lapatinib. CUDC-101 also suppressed the growth of the lapatinib-insensitive, triple-negative (estrogen receptor-, progesterone receptor- and HER2-negative) breast cancer cell line MDA-MB-231 as effectively as it did the lapatinib-sensitive, HER2-overexpressed lines BT-474 and SkBr-3. Similarly, CUDC-101 inhibits the growth of lung cancer cell lines that are not sensitive to erlotinib treatment, including H1975, which harbor an EGFR-T790M mutation. These results suggest that CUDC-101, with its synergistic inhibitions of multiple pathways, has the potential to enhance the response rates and prolong the duration of response when compared to traditional kinase inhibitors.

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

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 the preclinical CUDC-101 data presented in this publication may translate into clinical improvements when compared to currently approved and marketed EGFR, EGFR/HER2 and HADC drugs, the Company's estimate of the time to complete the dose escalation portion of the ongoing CUDC-101 Phase I clinical trial and its estimate of the period in which it will select an additional development candidate. 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


Posted: April 2010