Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the Company has entered into an agreement under which The Leukemia & Lymphoma Society (LLS) will support Curis’s ongoing development of its oral small molecule dual Pi3K and HDAC inhibitor CUDC-907, for patients with B-cell lymphoma and multiple myeloma. “We are delighted to collaborate with LLS to further develop CUDC-907. Our preclinical evidence suggests that its dual synergistic inhibition of PI3K and HDAC acts by disrupting cancer pathway networks that are important to the emergence and growth of B-cell lymphoma and multiple myeloma,” said Dan Passeri, Curis’s President and Chief Executive Officer. “LLS’s capital commitment to this program, along with their extensive knowledge of hematological malignancies, will be important resources as we seek to advance this promising first-in-class molecule.” This agreement was entered into as part of LLS’s Therapy Acceleration Program (TAP), a strategic initiative to speed the development of therapies that have the potential to change the standard of care for patients with blood cancers, especially in areas of high unmet medical need. “We look forward to working closely with Curis to accelerate the development of CUDC-907 for patients with B-cell lymphoma and multiple myeloma, who are often in critical need of new treatment options” said Richard Winneker, LLS’s senior vice president of research. Under the agreement, LLS will fund approximately 50% of the direct costs of the development of CUDC-907, up to $4 million. Curis is currently conducting preclinical studies of CUDC-907 required to file an investigational new drug application (IND) seeking to advance the molecule into a Phase Ia dose escalation clinical trial in B-cell lymphoma and multiple myeloma. Curis expects to file the IND and start patient enrollment in the second half of 2012. If this study is successful, LLS has also agreed to support Curis’s subsequent Phase Ib or Phase IIa study in one or more specific indications as well as Curis’ ongoing investigation of biomarkers for CUDC-907 in these diseases.
Curis will be obligated to continue development of CUDC-907 following the term of this agreement, provided that study results are positive and that there is a regulatory path forward and would be required to make a payment to LLS if it did not continue development in this success scenario. In the event that future studies of CUDC-907 are unsuccessful, the funding received from LLS would be treated as a non-refundable grant to Curis. Assuming that Curis licenses or partners CUDC-907 in B-cell lymphoma or multiple myeloma, or, in the event that Curis commercializes the drug candidate itself in these indications, Curis would be obligated to pay LLS future milestones of up to 2.5 times the funding amounts received from LLS under the agreement, primarily upon meeting defined regulatory submission, approval and commercialization objectives.About The Leukemia & Lymphoma Society The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services. Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET. www.lls.org. About Curis, Inc. Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at www.curis.com. Curis Cautionary Statement : 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 benefits of CUDC-907 in B-cell lymphoma and multiple myeloma, the anticipated development plans and timelines for this molecule, and the anticipated payments to be received by Curis under the arrangement. 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, including without limitation: the Company may experience adverse results, delays and/or failure in its efforts to continue to successfully advance the preclinical and clinical development of CUDC-907; the Company may be unable to maintain its agreement with LLS on the terms outlined herein, or at all; the Company may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of CUDC-907, the Company may not be able to obtain the substantial additional funding required to conduct its research and development programs; and other risk factors described by the Company in its Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 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.