Curis, Inc.

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Press Release $CRIS Curis, Inc.

0 COMMENTs 20 Jun
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Curis Announces U.S. Patent Issuance Strengthening Intellectual Property Position of PI3K-HDAC Inhibitor CUDC-907

LEXINGTON, Mass., June 20, 2013 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of various cancers, today announced the issuance of U.S. Patent No. 8,461,157, which claims methods of treating human diseases or disorders mediated by one or more of phosphoinositide 3-kinase (PI3K), mammalian target of rapamycin (mTOR) and histone deacetylase (HDAC) proteins, using compounds from a genus of small molecules with dual inhibitory properties, including but not limited to CUDC-907, a proprietary clinical stage dual inhibitor of PI3K and HDAC enzymes. This patent, along with another related patent issued in February 2013 (U.S. Patent No. 8,367,663), significantly enhances the intellectual property portfolio for Curis' proprietary chemical entities that target PI3K and HDAC, and in some instances mTOR, within a single molecule for the treatment of certain human diseases.

"We believe that this patent issuance significantly bolsters the intellectual property protection for Curis' proprietary dual targeted inhibitory molecules, including CUDC-907, a molecule that was invented by Curis scientists and is currently in Phase I clinical testing in patients with relapsed or refractory lymphomas or multiple myeloma," stated Dan Passeri, Curis' Chief Executive Officer. "As we continue to advance this current Phase I study, we are also planning to initiate additional studies with CUDC-907 in solid tumors later this year."

About CUDC-907

CUDC-907 is a dual inhibitor of the Class I PI3K, as well as Class I and II HDAC subtypes. Specifically, CUDC-907 is designed to inhibit PI3K-alpha, delta and beta isoforms and HDACs 1, 2, 3, 6 and 10, the combined inhibition of which Curis believes has synergistic effects against cancer cells and their microenvironment. In preclinical studies, CUDC-907 has demonstrated the ability to suppress multiple nodes of cellular survival and proliferation signaling pathways. In addition, preclinical data have shown that CUDC-907 inhibits compensatory pathways that are often utilized in cancer cells during the emergence of resistance to standard-of-care agents.

CUDC-907 exhibits potent 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 also inhibits tumor growth in preclinical xenograft models of blood cancers as well as solid tumors with K-RAS mutations that exhibit reduced sensitivity to single-target PI3K inhibitors. The development of CUDC-907 is in part funded by The Leukemia & Lymphoma Society (LLS) under an agreement established in 2011 between Curis and LLSs' Therapy Acceleration Program.

About the LLS Agreement

Under the agreement between Curis and LLS, LLS is expected to fund approximately 50% of the direct costs associated with the development of CUDC-907 through milestone payments that are contingent upon the achievement by Curis of specified clinical objectives, up to a maximum of $4 million. To date, Curis has earned $1.65 million in milestone payments from LLS.  In January 2013, Curis initiated a Phase I dose escalation clinical trial of CUDC-907 in patients with relapsed/refractory lymphomas or multiple myeloma.  If the Phase I study is successful, the agreement also provides for LLS to support CUDC-907's subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis' ongoing investigation of biomarkers for CUDC-907 in these diseases, subject to the $4 million maximum funding amount.  Under certain conditions associated with the successful partnering or commercialization of CUDC-907, Curis may be obligated to make payments to LLS up to a maximum of $10 million.

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services. Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org.  Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.

About Curis, Inc.

Curis is an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers. Erivedge® is the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma and is being commercialized and developed by Roche and Genentech, a member of the Roche Group, under a collaboration agreement between Curis and Genentech. Curis is also seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor. 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 Curis' expectations regarding: the strengthening of its intellectual property position for CUDC-907 due to the issuance of Patents No. 8,461,157 and 8,367,663; its plans and timing for conducting clinical studies with CUDC-907 in various indications; the potential benefits of CUDC-907; and its expectations regarding further funding of the CUDC-907 development program by LLS. 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, Curis and its collaborators may experience adverse results, delays and/or failures in their drug development programs. Curis' drug candidates may cause unexpected toxicities and/or fail to demonstrate sufficient safety and efficacy in clinical trials and may never achieve the requisite regulatory approval needed for commercialization. Curis will require substantial additional capital to fund the research and development of its drug development programs. The proceeds of Curis' royalty-secured loan may not be sufficient to fund its near-term capital requirements for advancing programs. Curis may not obtain or maintain necessary patent protection for its programs and could become involved in expensive and time consuming patent litigation and interference proceedings. Curis faces substantial competition from other companies developing cancer therapeutics. Unstable market and economic conditions may adversely affect Curis' financial conditions and its ability to access capital to fund the growth of its business. Curis also faces other important risks relating to its business, operations, financial condition and future prospects that are discussed in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 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: Mani Mohindru, Ph.D.
         Vice President, Corporate Strategy and Investor Relations
         617-503-6605
         mmohindru@curis.com

         Michael P. Gray
         Chief Business and Chief Financial Officer
         Curis, Inc.
         617-503-6632
         mgray@curis.com

Source: Curis, Inc.
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