Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Curis, a drug development company, has announced that its collaborator Genentech, a biotechnology company, treated the first patient in a pivotal Phase II clinical trial of GDC-0449, an orally administered small molecule hedgehog pathway inhibitor, as a single-agent therapy for patients with metastatic or locally advanced basal cell carcinoma.
Subscribe to our email newsletter
Under the companies’ collaboration agreement, Curis will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.
Genentech expects to evaluate GDC-0449 in approximately 100 patients with metastatic or locally advanced basal cell carcinoma (BCC) in a global single-arm, two-cohort clinical trial. One cohort includes all patients with histologically confirmed, RECIST measurable metastatic BCC. The second cohort includes histologically confirmed locally advanced BCC that is considered inoperable by the treating physician. All patients will receive a daily oral dose of GDC-0449.
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.