Curis Expands Oncology Pipeline with an Oral Small Molecule PD-L1/TIM-3 Immune Checkpoint Antagonist

CA-327, a PD-L1/TIM3 dual antagonist designed and optimized by Aurigene, licensed as the 2nd oral small molecule immuno-oncology development candidate under the Curis Aurigene collaboration

LEXINGTON, Mass., Oct. 11, 2016 (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 the expansion of its pipeline with CA-327, an oral, small molecule immune checkpoint antagonist targeting programmed death ligand-1 (PD-L1) and T-cell immunoglobulin and mucin domain containing protein-3 (TIM-3).

Curis licensed the PD-1/ TIM-3 antagonist program, and designated CA-327 as the development candidate, by exercising its option under the collaboration, license and option agreement established with Aurigene in January 2015. The collaboration is focused on the discovery, development and commercialization of small molecule drug candidates in the fields of immuno-oncology and selected precision oncology targets.  The previous licensed programs within the collaboration include CA-170, a first-in-class oral, small molecule antagonist targeting 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-4948, an oral small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) that is completing IND-enabling studies.

In addition to targeting PD-L1, a negative regulator of immune activation, CA-327 also targets TIM-3, an inhibitory checkpoint molecule that plays an important role in immune suppression and is co-expressed with programmed cell death-1 (PD-1) receptors on exhausted cytotoxic T cells in tumor tissues as well as expressed on certain regulatory T cells.

The in-license of CA-327 comes three months after the collaboration’s first oral immuno-oncology program entered the clinic and less than a month after a $24.5M investment in Curis by Aurigene.

“We are pleased with the progress of our collaboration,” said Dr. Ali Fattaey, Curis's CEO, “and look forward to working with our partner, Aurigene, to complete IND-enabling studies for CA-327 in the coming months and expect to file an IND in 2017.”

“We are delighted that our collaboration is advancing its third small molecule program in less than 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 in the field of oncology, 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. The company's clinical drug candidates include CUDC-907, which is being investigated in a Phase 2 trial in patients with Diffuse Large B Cell Lymphoma, or DLBCL, and in a separate Phase 1 trial in patients with solid tumors. As part of a broad collaboration with Aurigene, Curis has an exclusive license to CA-170, an oral small molecule PD-L1/VISTA antagonist that is currently being investigated in a Phase 1 trial in patients with solid tumors or lymphoma. Curis also has an exclusive license to molecules designed to inhibit IRAK4, including CA-4948, currently in the pre-IND stage of development. 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

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," "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

Media Contact:
David Schull
Russo Partners

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