Curis Publishes CUDC-101 Medicinal Chemistry Data

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 medicinal chemistry paper related to the discovery of CUDC-101, Curis’s HDAC, EGFR and Her2 inhibitor, was published online in the Journal of Medicinal Chemistry and also will be published in an upcoming print version of the journal. The paper describes the structure-based rational drug design, synthesis and structure-activity relationship (SAR) of a class of novel compounds that included CUDC-101 and the identification of CUDC-101 as a clinical candidate. Related in vitro and in vivo data associated with these compounds are also included.

“We look forward to providing data for the ongoing Phase I clinical development program and beginning the next stage of clinical testing for this molecule later this year.”

“This publication underscores both the quality of the research at Curis and the productivity of our research group. Remarkably, CUDC-101 was the subject of an IND filing only two years after the synthesis of the first set of compounds within this class of molecules, and since then, a U.S. patent covering CUDC-101 has been issued,” stated Dan Passeri, Curis’ President and Chief Executive Officer. “We look forward to providing data for the ongoing Phase I clinical development program and beginning the next stage of clinical testing for this molecule later this year.”

CUDC-101, a small organic molecule of the quinazoline class, inhibits several clinically and commercially validated cancer targets at the same time. The cancer targets were chosen for their potential of mechanistic synergy and include class I and II histone deacetylases, or HDACs, EGFR and Her2. The publication indicates that CUDC-101 is significantly more potent than first-in-class drugs targeting EGFR and HDAC or combinations thereof in a variety of in vitro studies. CUDC-101 promotes tumor regression or inhibition in vivo in various cancer xenograft models, including non-small cell lung, liver, breast, head and neck, colon and pancreatic cancers. The data presented suggest that a single compound that simultaneously inhibits HDAC, EGFR and HER2 may offer greater therapeutic benefits in cancer over single-acting agents and may address significant clinical needs in the treatment of patients who are unresponsive or resistant to EGFR-inhibitors.

CUDC-101 is currently in a dose escalation Phase I clinical trial, which is expected to conclude in the first half of 2010, with the establishment of a maximum tolerated dose and dose limiting toxicities.

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, including in the Hedgehog signaling pathway, 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 the Company’s statements regarding the expected timing of completion of the ongoing dose escalation Phase I clinical trial and that CUDC-101 may offer greater therapeutic benefits in cancer over single-acting agents and may address significant clinical needs in the treatment of EGFR-inhibitor unresponsive or resistant patients. 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 Debiopharm may experience adverse results, delays and/or failures in their strategic alliance transactions with Curis. For example, Genentech may not be able to replicate in later trials any favorable outcomes from earlier trials of GDC-0449 in BCC, colorectal cancer, ovarian cancer and medulloblastoma and Debiopharm may not be able to successfully advance CUDC-305 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, including with respect to the timing of key regulatory filings.
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, and may not received additional anticipated milestone 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 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 Debiopharm 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.