Press Releases

Curis Collaborator Aurigene Presents Preclinical Data From Oral Small Molecule PD-L1/VISTA and IRAK4 Programs at AACR-NCI-EORTC International Conference

LEXINGTON, Mass., Nov. 8, 2015 (GLOBE NEWSWIRE) -- Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, announced today that its collaborator Aurigene presented preclinical data from two programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics including: (1) CA-170 (previously AUPM-170), a first-in-class oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA), and (2) the interleukin-1 receptor associated kinase 4 (IRAK4) inhibitor program. Curis recently exercised options to license both these programs under a collaboration agreement with Aurigene established earlier this year.

CA-170 (PD-L1/VISTA antagonist) presentation:

Aurigene presented a poster entitled "First-in-class orally available immune checkpoint antagonists for cancer therapy" on Friday, Nov. 6. The presentation included data from in vitro functional studies, which showed that CA-170 can rescue effector functions of T cells (such as cytokine secretion) that are inhibited specifically by interactions of PD-L1/L2 and VISTA checkpoint proteins but does not impact T cells functions that are modulated as a result of interactions of other checkpoint regulators such as TIM-3, CTLA4, LAG-3 and BTLA with their respective counterparts. Additionally, studies conducted with isolated human T cells demonstrate that short exposures to CA-170 (in the order of a few hours) are adequate to rescue and sustain activation of T cells functions. Daily oral administration of CA-170 resulted in anti-tumor activity in multiple syngeneic tumor models including melanoma and colon cancer but no activity was observed in immune deficient SCID-Beige mice, suggesting that the anti-cancer effects of CA-170 are mediated via activation of immune responses to these cancers.

"The collective in vitro and animal model data are very compelling and strongly support testing of CA-170 in human clinical trials in multiple cancers," said Ali Fattaey, Ph.D., Curis' President and CEO. "We are working with Aurigene to complete the IND enabling studies for CA-170 and initiate clinical studies in the first half of 2016."

IRAK4 inhibitor presentation:

Aurigene poster entitled "Efficacy of novel IRAK4 inhibitors in ABC-DLBCL and AML models" was presented on Sunday, Nov. 8. This presentation included data from chemically distinct series of small molecule compounds with potent IRAK4 inhibitory activity in biochemical assays. Anti-tumor activity of lead compounds was confirmed in a MYD88 mutant DLBCL xenograft tumor model. Lead compounds also inhibited inflammatory responses in an in vivo model, suggesting that IRAK4 inhibitors have the potential for use in the treatment of inflammatory diseases. Preliminary in vivo safety studies demonstrate a favorable therapeutic index for further development of lead compounds for potential human testing.

About Curis, Inc.

Curis is a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of cancers, including its lead development candidate, CUDC-907, an oral dual HDAC and PI3K inhibitor that is being investigated in two clinical studies in patients with lymphomas and solid tumors. Curis is also engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of the PD-1 pathway/ VISTA, including PD-L1/VISTA antagonist CA-170, as well as to molecules designed to inhibit IRAK4. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are developing and commercializing Erivedge® for the treatment of advanced basal cell carcinoma. 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 statements about Curis' expectations regarding its plans to complete IND enabling studies and initiate clinical studies of CA-170 in first half of 2016; Curis' ability to advance molecules from the collaboration into clinical development; and any other statements regarding the Company's plans, strategies and prospects. Forward-looking statements used in this press release may also 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, there can be no guarantee that the collaboration agreement with Aurigene will continue for its full term, that Curis or Aurigene will each maintain the financial resources necessary to continue financing its portion of research, development and commercialization costs or that the parties will successfully discover, develop or commercialize drug candidates under the collaboration. Curis' expectations could also be affected by risks and uncertainties relating to a failure of Curis or Aurigene to fully perform under the collaboration agreement and/or any early termination of the collaboration agreement, adverse results of clinical trials and preclinical studies that are the subject of the collaboration, including subsequent analysis of existing data and new data received from ongoing and future studies, the content and timing of decisions made by the U.S. Food & Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies, and Curis' ability to enroll patients in clinical trials that may be initiated under the collaboration. Furthermore, Curis or Aurigene may not obtain or maintain necessary patent protection for the programs that are the subject of the collaboration 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 and developments relating to Curis's business 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2015 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 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: For More Information:

         Mani Mohindru, Ph.D.

         Senior Vice President,

         Corporate Strategy and Investor Relations

         Curis, Inc.



         Media Contact

         David Schull

         Russo Partners

         (212) 845-4271