Curis, Inc., a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, has entered into an agreement with the Leukemia & Lymphoma Society (LLS), the world's largest voluntary health agency dedicated to blood cancer.
Under the terms of the agreement, the 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 programme, along with their extensive knowledge of haematological 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 per cent 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.
The Leukemia & Lymphoma Society (R) (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukaemia, 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.