Press Releases

Curis Announces U.S. Patent Issuance Covering CUDC-907 Composition-of-Matter
Dual HDAC and PI3K Inhibitor in Ongoing Phase 1 Study in Patients With Relapsed/ Refractory Lymphoma and Multiple Myeloma

LEXINGTON, Mass., April 30, 2014 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused company developing novel, targeted drug candidates for the treatment of human cancers, today announced the issuance of U.S. Patent No. 8,710,219 entitled "Phosphoinositide 3-kinase inhibitor with a zinc binding moiety" that covers composition-of-matter for CUDC-907, Curis' dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor. This patent, along with related patents issued in June 2013 (U.S. Patent no. 8,461,157) and February 2013 (U.S. Patent No. 8,367,663), covers a broad range of proprietary chemical entities that target HDAC and PI3K enzymes, and in some instances mammalian target of rapamycin (mTOR), within a single molecule for the treatment of certain human diseases. CUDC-907 is being investigated in a Phase 1 study in patients with relapsed/ refractory lymphoma or multiple myeloma.

"This patent issuance adds to Curis' strong intellectual property portfolio and is expected to further protect our investment in our promising drug candidate, CUDC-907. It highlights the innovation behind combining two distinct inhibitory moieties that target HDAC and PI3K enzymes in a single chemical structure," stated Ali Fattaey, Ph.D., Curis' President and Chief Operating Officer. "We are encouraged by the progress being made in CUDC-907's ongoing Phase 1 dose escalation study and expect to initiate the expansion phase of the trial in select hematologic indications later this year."

About CUDC-907

CUDC-907 is a dual inhibitor of Class I and II HDAC, as well as Class I PI3K enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms, 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 affect 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. The development of CUDC-907 is in part funded by The Leukemia & Lymphoma Society (LLS) under an agreement established in 2011 between Curis and LLS's Therapy Acceleration Program.

About Curis, Inc.
Curis is an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers. Curis is seeking to further the development of its pipeline of proprietary targeted cancer drug candidates, including CUDC-907, a dual HDAC and PI3K inhibitor, and CUDC-427, a small molecule antagonist of IAP proteins. Curis is also engaged in a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are developing and commercializing Erivedge®, the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Curis-discovered HSP90 inhibitor, Debio 0932 is being studied in patients with advanced lung and kidney cancers by partner Debiopharm. For more information, visit Curis' website at www.curis.com.

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 the expected protective benefits of the Company's patent portfolio covering CUDC-907; expressed or implied statements about the efficacy, safety and potential benefits of CUDC-907; and Curis' plans and timelines  for development of CUDC-907, including its plans to initiate the expansion phase of the CUDC-907 Phase 1 trial in select hematologic indications later this year. 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, CUDC-907's ongoing clinical trial could be subject to  delays and setbacks, such as slower than expected enrollment rates, unanticipated regulatory actions, and adverse clinical outcomes which could make more costly or otherwise adversely impact Curis' future development plans for CUDC-907. Curis' drug candidates, including CUDC-907, are unproven and 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, and such capital may be difficult to obtain. 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 condition 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 Annual Report on Form 10-K for the year ended 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: For More Information:

         Mani Mohindru, Ph.D.

         Vice President, Corporate Strategy and Investor Relations

         Curis, Inc.

         617-503-6605

         mmohindru@curis.com

         

         Michael P. Gray

         Chief Financial and Chief Business Officer

         Curis, Inc.

         617-503-6632

         mgray@curis.com