The Leukemia & Lymphoma Society (LLS) has pledged up to $4 million in funding to support continued development of Curis’ B-cell lymphoma and multiple myeloma candidate CUDC-907. The oral small molecule dual PI3K and HDAC inhibitor is currently in preclinical development, and clinical trials are projected to start in the second half of 2012.
If an initial Phase I dose-escalation study is successfully completed, LLS has in addition agreed to support a subsequent Phase Ib or Phase IIa study carried out by Curis in one or more indications, along with the company’s ongoing research to develop biomarkers for CUDC-907 in the B-cell lymphoma and multiple myeloma indications. The agreement is part of LLS’s Therapy Acceleration Program (TAP) initiative to speed the development of treatments for patients with blood cancers.
For its part, Curis is obliged to continue developing CUDC-907 as long as the study results are positive and a regulatory path is evident. The firm will be liable to pay LLS future milestones of up to 2.5 times the funding total it received for the organization, either if the firm licenses out or partners CUDC-907 in the B-cell lymphoma or multiple myeloma indication, or if it commercializes the drug itself.
Curis is exploiting expertise in signaling pathways to generate targeted small molecule drug candidates for cancer. Lead candidate vismodegib is a hedgehog pathway inhibitor, which is in development in partnership with Genentech for the treatment of advanced basal cell carcinoma and operable basal cell carcinoma. Genentech filed an NDA for the advanced basal cell carcinoma indication in September, and it has been granted priority review status by FDA. Phase II studies with vismodegib are under way in less severe forms of the disease.
Curis’ in-house pipeline includes the anticancer candidate CUDC-101, an HDAC, EGFR, and Her2 inhibitor currently in Phase I development. The firm’s Hsp90 inhibitor Debio 0932 (formerly known as CUDC-305) has been licensed to Debiopharm, and is currently undergoing Phase Ib clinical evaluation.