Curis and Aurigene Extend Exclusivity Period of Im

LEXINGTON, Mass., Jan. 09, 2017 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq: CRIS ), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of cancer, today announced that it has exercised its option to extend the exclusivity period with Aurigene under the collaboration, license and option agreement established in January, 2015.  As previously reported, the extension of exclusivity is associated with a payment of $7.5 million to Aurigene, payable in two equal installments in the first and third quarters of 2017.

The collaboration between Curis and Aurigene is focused on the discovery, development and commercialization of small molecule drug candidates in the fields of immuno-oncology and selected precision oncology targets.  Licensed programs within the collaboration include CA-170, a first-in-class oral, small molecule antagonist targeting programmed death ligand-1 (PD-L1) and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints that is currently being studied in a Phase 1 trial in patients with solid tumors and lymphomas; and CA-327, an oral, small molecule immune checkpoint antagonist targeting PD-L1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3) and CA-4948, an oral small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4), both of which are currently completing IND-enabling studies.

The exclusivity extension comes two months after initial data from the CA-170 Ph. 1 Clinical Trial were presented at a scientific meeting – and four months after the companies closed a $24.5M investment in Curis by Aurigene.

“The Curis-Aurigene partnership has been very productive in designing and developing oral, small molecule inhibitors of immune checkpoints for cancer therapy,” said Dr. Ali Fattaey, Curis's CEO, “With the CA-170 Phase 1 Clinical Trial now well under way, we look forward to working with our partner, Aurigene, to initiate the first clinical trial of CA-327 planned for later this year, and the expected selection of additional collaboration programs in the years to come.”

“We are delighted that our collaboration has advanced three small molecule programs in the last two years,” said CSN Murthy, Aurigene’s CEO. “We continue to work closely with Curis to focus our collective resources, creating and developing innovative drug candidates for cancer patients, including multiple first-in-class oral small molecule checkpoint antagonists within immuno-oncology.”

About Curis, Inc. Curis is a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, including its lead development candidate, CUDC-907 that is being investigated in 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 and VISTA pathways, including PD-L1/VISTA antagonist CA-170, and oral small molecule antagonists of the PD-1 and TIM-3 pathways, including PD-L1/TIM-3 antagonist CA-327, as well as to molecules designed to inhibit the IRAK4 kinase, including CA-4948.  CA-170 is currently undergoing testing in a Phase 1 trial in patients with advanced solid tumors and lymphomas. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma, and are further developing Erivedge in other diseases including idiopathic pulmonary fibrosis and myelofibrosis. For more information, visit Curis's 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 potential advantages and benefits of small molecule checkpoint inhibitors and Curis’s plans and expectations for the collaboration with Aurigene, including its plans to  discover and develop multiple first-in-class oral, small molecule checkpoint inhibitors for the treatment of patients with cancer . Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "seeks," "estimates," "assumes," "will," "may," “look forward,” "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 may experience adverse results, delays and/or failures in its drug development programs and may not be able to successfully advance the development of its drug candidates in the time frames it projects, if at all. Curis's drug candidates may cause unexpected toxicities, fail to demonstrate sufficient safety and efficacy in clinical studies and/or may never achieve the requisite regulatory approvals needed for commercialization. Favorable results seen in preclinical studies and early clinical trials of Curis’s drug candidates may not be replicated in later trials.  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 and other resources necessary to continue financing its portion of the research, development and commercialization costs, that the parties will successfully discover, develop or commercialize drug candidates under the collaboration, or that Curis receive full or partial benefit of payments waived by Aurigene . Curis Royalty may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy its royalty-collateralized debt obligation or may otherwise lose its rights to Erivedge royalties and royalty-related payments as a result of a foreclosure of the loan. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. Curis also faces risks relating to: potential adverse decisions made by the FDA and other regulatory authorities, investigational review boards, and publication review bodies; competition; its ability to obtain or maintain necessary patent protection; unstable market and economic conditions;  unplanned expenses; and  other important risks relating to its business, operations, financial condition and future prospects that are discussed in its most recent Form 10-K and Form 10-Q 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's 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.

Company Contact: James E. Dentzer Chief Financial Officer & Chief Administrative Officer 617-503-6500 jdentzer@curis.com Media Contact: David Schull Russo Partners 212-845-4271 david.schull@russopartnersllc.com