Press Releases

Curis Presents Data on PI3K and HDAC Inhibitor CUDC-907 at AACR Annual Meeting 2012

LEXINGTON, Mass., April 4, 2012 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), a drug development company seeking to develop proprietary targeted medicines for cancer treatment, today announced the presentation of data in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2012 in Chicago, Illinois. The poster presentation, titled "Antitumor Activity of CUDC-907, a Dual PI3K and HDAC Inhibitor in Hematological Cancer Models", was presented by Rudi Bao, M.D., Ph.D., Curis' Senior Director of Oncology on April 3rd.

"We are encouraged by the CUDC-907 data presented at AACR, which are largely focused on preclinical models of the hematological malignancies that we are planning to target in our planned Phase I clinical trial," stated Dan Passeri, Curis President and Chief Executive Officer.  "We are very pleased to collaborate with The Leukemia & Lymphoma Society (LLS) on the early clinical development of CUDC-907, and under our agreement, LLS will provide support of the ongoing development of CUDC-907 for patients with B-cell lymphoma and multiple myeloma as part of its Therapy Acceleration Program, a strategic initiative to speed the development of therapies with the potential to change the standard of care for patients with blood cancers, especially in areas of high unmet medical need. We anticipate that we will file an Investigational New Drug application (IND) for this molecule in the third quarter of this year."

The poster presentation focused on CUDC-907's biologic activity in cell culture and animal models of various hematological cancers, with a particular focus on multiple myeloma and B-cell lymphoma.  In in vitro and in vivo testing, CUDC-907 outperformed a first-in-class HDAC inhibitor as well as an investigational pan-PI3K (Class I) inhibitor given as a single agent or in a combination of both agents. CUDC-907 also demonstrated enhanced antitumor activity in animal models of B-cell lymphoma and multiple myeloma when co-administered with standard of care agents used in the treatment of patients with these malignancies.

Furthermore, this poster showed that many commonly used in vivo models of B-cell lymphoma and multiple myeloma expressed various PI3K Class I isoforms, suggesting that a pan-PI3K inhibitor such as CUDC-907 may be of greater benefit in many cases than a PI3K inhibitor that is focused narrowly on one PI3K isoform. Accordingly, CUDC-907 showed greater biologic activity than a delta-specific investigational inhibitor in a number of hematological cancer cells in vitro, and showed greater growth-inhibitory activity in an animal model of non-Hodgkin's Lymphoma.

Curis' discovery and development efforts are focused on building a portfolio of small molecule network-targeted inhibitors against a wide range of cancer types. The leading compounds within Curis' research and development programs are designed to inhibit one or more cancer targets, including EGFR, Her2 and PI3K, as well as the inhibition of histone deacetylase, or HDAC, a validated non-kinase cancer target. Each target combination is chosen for its potential of mechanistic synergy, offering a differentiated, potential breakthrough approach to cancer therapy, intended to disrupt cancer resistance networks.     

About CUDC-907

CUDC-907 is a potent inhibitor of the Class I PI3K and Class I and II HDAC subtypes, the combination of which Curis scientists believe has synergistic interaction against cancer cells.  CUDC-907 has demonstrated the ability to suppress multiple nodes of survival, proliferation and cell death pathways. In addition, preclinical data have shown that CUDC-907 also inhibits compensatory pathways often utilized in cancer cells during the emergence of resistance to standard of care agents and induces apoptosis in treated cancer cells.

CUDC-907 exhibits anti-proliferation activity against a broad range of cancer cell types in in vitro studies, including cell lines that exhibit reduced sensitivity to single-target PI3K inhibitors. CUDC-907's anti-proliferation activity has been demonstrated to be up to 100 times more potent than that of two leading PI3K inhibitors in development.  The molecule outperforms both the combination of the commercially available HDAC inhibitor vorinostat plus the investigational pan-PI3K inhibitor GDC-0941, and the investigational delta isoform-specific inhibitor CAL-101 in all cell lines tested.

CUDC-907 also inhibits tumor growth in preclinical xenograft models of hematology cancers and solid tumors with K-RAS mutations that exhibit reduced sensitivity to known PI3K inhibitors, indicating that this compound may have broader activity than other leading PI3K inhibitors currently in clinical development. Based on its synergistic mechanism of cancer signaling network disruption, efficacy in a number of preclinical xenograft models and favorable preclinical safety profile, Curis has selected CUDC-907 as its next candidate for clinical development.

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. Curis is building upon its previous experiences in targeting signaling pathways, including the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at www.curis.com.

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Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding our estimated timeline for our filing an IND application for CUDC-907. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may," "could" 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 actual results to be materially different from those indicated by such forward-looking statements. For example, we may not successfully complete the preclinical studies and drug product manufacturing that are required to file an IND in the third quarter of this year, or at all. Curis also faces other important risks relating to its business, operations, financial condition and future prospects generally, that are discussed in its Annual Report on Form 10-K for the year ended December 31, 2011 and other filings that it periodically makes with the Securities and Exchange Commission.

In addition, any forward-looking statements represent the views of Curis 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: Michael P. Gray

         Chief Financial and Chief Operating Officer

         Curis, Inc.

         617-503-6632

         mgray@curis.com