Curis, a drug development company, has announced that its collaborator Genentech and the National Cancer Institute’s division of cancer treatment and diagnosis are planning to enter into a cooperative R&D agreement which will allow the NCI to explore GDC-0449, an orally-administered small molecule Hedgehog pathway Inhibitor, in a number of cancer indications.
A division of cancer treatment and diagnosis-sponsored Phase I clinical trial is expected to be initiated to evaluate dose and safety of GDC-0449 in pediatric patients with medulloblastoma.
In addition to this Phase I medulloblastoma clinical trial, the National Cancer Institute (NCI) plans to sponsor additional clinical trials under this cooperative R&D agreement (CRADA), including clinical trials in patients with small cell lung and pancreatic cancers, among others.
Under Curis’s ongoing collaboration agreement with Genentech, Curis provided broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. Through this collaboration, GDC-0449 was discovered by Genentech and was jointly validated by the parties through a series of preclinical studies. Genentech and Roche collaborate on the clinical development and commercialization of GDC-0449.
Curis is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449. Curis is not entitled to receive additional cash payments on the initiation of clinical trials conducted under this collaboration with NCI.
Dan Passeri, president and CEO of Curis, said: We are very pleased that Genentech is planning to enter into this CRADA with NCI to advance the development efforts of GDC-0449. Genentech has a broad GDC-0449 Phase II clinical program, including trials in colorectal cancer, advanced ovarian cancer and advanced basal cell carcinoma, and we believe that this agreement with the NCI may allow for GDC-0449 to be tested in many additional cancer indications.