Curis Presents Preclinical Data on CUDC-427 at AACR Annual Meeting

LEXINGTON, Mass., April 22, 2015 (GLOBE NEWSWIRE) -- Curis, Inc. (Nasdaq: CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, announced today data presented from in vitro and in vivo studies for CUDC-427, an antagonist of inhibitor of apoptosis (IAP) proteins, at the American Association for Cancer Research (AACR) 2015 Annual Meeting. CUDC-427 is being studied in a Phase 1 trial in patients with advanced solid tumors or lymphoma. Curis' collaborator, Aurigene Discovery Technologies Limited, also reported preclinical data on its interleukin-1 receptor association kinase-4 (IRAK-4) inhibitor program at AACR.

CUDC-427 presentations:

Curis scientists presented two CUDC-427 posters at AACR. The first poster, "Predictive biomarker signatures for IAP inhibitor CUDC-427," discussed data from in vitro and in vivo studies that were conducted to identify predictive gene signatures that may be associated with drug response in ovarian and breast cancers. The drug response and genomic/expression profiles of 29 breast and ovarian patient-derived xenografts (PDX) were used to generate a set of gene signatures that will be further validated in additional PDX models and patient samples derived from ongoing clinical testing of CUDC-427.

The second poster, "IAP inhibitor CUDC-427 induces tumor regression or stasis in preclinical models of B-cell lymphoma," reported data from in vitro and in vivo studies showing CUDC-427 anti-tumor activity in multiple hematologic cancer models, including diffuse large B-cell lymphoma (DLBCL). Data from a panel of human hematologic cell lines showed that the DLBCL cell lines were most sensitive to CUDC-427 treatment in growth inhibition assays. The anti-tumor effect of CUDC-427 was further confirmed in in vivo studies where daily dosing of CUDC-427 induced tumor regression or stasis in certain DLBCL xenograft and B-cell lymphoma syngeneic mouse models.

IRAK-4 program presentation:

Curis' collaborator Aurigene presented a poster entitled "Novel IRAK-4 inhibitors exhibit highly potent anti-proliferative activity in DLBCL cell lines with activating MYD88 L265P mutation" that included data from multiple chemically distinct series of potent oral IRAK-4 inhibitors. These compounds were shown to potently inhibit IRAK-4 kinase activity in biochemical assays as well as proliferation of MYD88 mutant DLBCL cell lines. Anti-tumor activity in DLBCL was further confirmed in a MYD88 mutant xenograft model. Some of these compounds also significantly reduced disease burden in a rat collagen-induced arthritis model, an in vivo model for inflammation.

"We are pleased with the promising preclinical activity of the IRAK-4 targeting compounds in both cell-based and animal models, especially in MYD88 mutant DLBCL tumor models," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "It has been shown that activating mutations in the MYD88 gene lead to dysregulation of its downstream target IRAK-4 in a number of hematologic malignancies, including Waldenström's Macroglobulinemia and a subset of DLBCLs, making IRAK-4 an attractive target for the treatment of these cancers. We expect to select a development candidate and to exercise the option to exclusively license molecules within this program shortly thereafter under the terms of our collaboration agreement. We continue to anticipate IND filing for this program later this year."

About CUDC-427

CUDC-427 is an oral, small molecule Smac mimetic drug candidate that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. IAP proteins are a family of functionally and structurally related proteins that promote cancer cell survival by inhibiting programmed cell death, also known as apoptosis, which is a normal process inherent in every cell. Using IAP proteins and other anti-apoptotic factors, cancer cells evade apoptosis in response to a variety of signals, including those provided by anti-cancer agents such as chemotherapy, or naturally occurring inflammatory and immune signals transmitted through members of the tumor necrosis factor (TNF) family. IAP inhibitors such as CUDC-427 are designed to counteract the effects of IAP proteins, thus shifting the balance away from cancer cell survival and allowing apoptosis to proceed.

About IRAK-4

Interleukin-1 receptor-associated kinase 4 (IRAK-4) is a signaling kinase that becomes inappropriately activated in certain cancers including activated B-cell-diffuse large B-cell lymphoma (ABC-DLBCL), an aggressive form of lymphoma with poor prognosis. There appears to be a mechanistic link with IRAK-4 in ABC-DLBCL where these tumors from approximately 35% of patients harbor oncogenic mutations in the MYD88 gene, which encodes an adaptor protein that interacts directly with IRAK-4. MYD88 mutations appear to constitutively activate the IRAK-4 kinase complex, driving pro-survival pathways in ABC-DLBCL disease. Oncogenic MYD88 mutations have also been identified in other cancers, including in over 90% of patients with Waldenström's Macroglobulinemia as well as in a subset of patients with chronic lymphocytic leukemia (CLL).

About Curis, Inc.

Curis is a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers. Curis' pipeline of drug candidates includes CUDC-907, a dual HDAC and PI3K inhibitor, CUDC-427, a small molecule antagonist of IAP proteins, and CUDC-305, an oral HSP90 inhibitor. Curis is also engaged in a broad collaboration with Aurigene in the areas of immuno-oncology and precision oncology. Curis is also party to a collaboration agreement 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. For more information, visit Curis' website at www.curis.com.

About Aurigene

Aurigene is a specialized, discovery stage biotechnology company, developing novel and best-in-class therapies to treat cancer and inflammatory diseases. Aurigene's Programmed Death pathway program is the first of several immune checkpoint programs that are at different stages of discovery and preclinical development. Aurigene has partnered with several large- and mid-pharma companies in the United States and Europe and has delivered multiple clinical compounds through these partnerships. With over 500 scientists, Aurigene has collaborated with 6 of the top 10 pharma companies. Aurigene is an independent, wholly owned subsidiary of Dr. Reddy's Laboratories Ltd. (NYSE: RDY). For more information, please visit Aurigene's website at http://aurigene.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 Curis' expectations about the potential therapeutic benefits of IRAK-4; Curis' plans to select a development candidate and to exercise the option to exclusively license molecules under the IRAK-4 program with Aurigene; its anticipated timing for an IND filing for the program; and any other statements about Curis' business, plans, prospects and strategies . 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. There can be no guarantee that Curis' collaboration agreement with Aurigene will continue for its full term, that Curis or Aurigene will 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. Genentech and Roche may experience delays or failures in the manufacture and commercialization of Erivedge, regulatory authorities may determine to delay or restrict Genentech's and/or Roche's ability to continue to develop or commercialize Erivedge, and competing drugs may be developed that are superior to Erivedge, any of which could adversely affect the amount of royalty revenue that Curis receives from sales of Erivedge. Curis also faces risks relating to its wholly-owned subsidiary's Erivedge royalty-collateralized loan transaction, including the risk that it may not receive sufficient levels of royalty revenue from sales of Erivedge to satisfy the debt obligation or may otherwise lose its rights to royalties and royalty-related payments as a result of a foreclosure of the loan. 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. Curis will require substantial additional capital to fund its business and such capital may not be available on reasonable terms, or at all. 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-K for the year ended December 31, 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: For More Information:
         Mani Mohindru, Ph.D.
         Vice President, Corporate Strategy and Investor Relations
         Curis, Inc.
         617-503-6605
         [email protected]

         Media Contact
         David Schull
         Russo Partners
         (212) 845-4271
         [email protected]

Source: Curis, Inc.

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