Press Releases

Curis Announces Allowance of U.S. Patent Covering Compounds Targeting HDAC and PI3K Activities in a Single Molecule

LEXINGTON, Mass., Oct. 28, 2014 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq:CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced the receipt of a Notice of Allowance of a U.S. patent that covers a broad genus of compounds that target histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) activities in a single chemical structure including CUDC-907, Curis' oral, dual HDAC and PI3K small molecule inhibitor that is currently being studied in Phase 1 clinical trials. This patent, along with prior patents issued to Curis, further strengthens the Company's intellectual property portfolio of compounds including CUDC-907 that inhibit HDAC and PI3K enzymes in a single small molecule for the treatment of certain human diseases.

Collectively, these patents generically cover composition-of-matter and methods of use of CUDC-907 as well as 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.

"The allowance of the most recent patent application further enhances Curis' strong intellectual property portfolio and protection around our promising drug candidate, CUDC-907. Additionally, it also emphasizes the novelty and importance of combining two distinct inhibitory moieties that target HDAC and PI3K enzymes in a single molecule," stated Michael Gray, Curis' Chief Financial and Business Officer. "We are encouraged by the progress being made in CUDC-907's program and look forward to data from the expansion phase of the trial to understand the role of this molecule in the treatment of patients with diffuse large B cell lymphoma and multiple myeloma."

CUDC-907 is being investigated in a first-in-human Phase 1 study in patients with relapsed/ refractory lymphoma or multiple myeloma. As part of the Phase 1 study, Curis has also opened expansion cohorts to enroll patients with diffuse large B cell lymphoma and multiple myeloma. In addition, Curis also expects to initiate an additional study under a second open IND that will enroll patients with advanced solid tumors, including patients with hormone receptor positive breast cancer, among others.

About CUDC-907:

CUDC-907 is an oral, 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. It is currently undergoing investigation in a first-in-human trial to assess its safety, pharmacokinetics and preliminary anti-cancer activity in patients with relapsed/ refractory lymphomas and multiple myeloma. 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 biotechnology company developing novel drug candidates for the treatment of human cancers. Curis' pipeline of drug candidates includes 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 partner Debiopharm is studying HSP90 inhibitor, Debio 0932 in patients with advanced lung cancer. For more information, visit Curis' website at

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 Curis' expectations regarding: its plans and timing for conducting ongoing and planned 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 June 30, 2014 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, except as may be required by law.

CONTACT: Mani Mohindru, Ph.D.

         Vice President, Corporate Strategy and Investor Relations

         Curis, Inc.



         Michael P. Gray

         Chief Financial and Chief Business Officer

         Curis, Inc.