Pipeline
Curis is developing targeted small molecule drug candidates for cancer indications where there are substantial unmet therapeutic needs.
The Hedgehog pathway inhibitor program in collaboration with Genentech is our most advanced program. In September 2011, Genentech submitted a New Drug Application (NDA) to the FDA for vismodegib (GDC-0449, RG3616) in advanced basal cell carcinoma and is also conducting a Phase II clinical trial of the molecule in less severe forms of basal cell carcinoma. In addition, there are several additional Phase I and II clinical trials ongoing under a collaboration between Genentech and independent investigators and the National Cancer Institute.
Our second development candidate under collaboration is Debio 0932 (formerly CUDC-305), an Hsp90 inhibitor that we licensed to Debiopharm Group in August 2009 and that is currently in Phase Ib clinical testing.
Curis has focused most of its internal resources on developing additional small molecule targeted cancer drug candidates. Curis completed a Phase I clinical trial of CUDC-101, a first-in-class inhibitor of EGFR, Her2 and HDAC, in the first half of 2010. The Company also initiated in August 2010 a Phase Ib expansion trial of this molecule in patients with breast, gastric, head and neck, liver and non-small cell lung cancers and in August 2011 initiated a Phase I clinical trial in HPV- locally advanced head and neck cancer in combination with standard-of-care treatment (cisplatin and radiation).
In addition, Curis has several programs that are in various stages of preclinical drug development. Because of the early stages of development of these programs, its ability and that of the Company's collaborators and licensors to successfully complete preclinical and clinical studies of these product candidates, and the timing of completion of such programs, is highly uncertain.
