Thursday, Curis, Inc. (CRIS), a cancer drug developer, said that its collaborator Genentech, Inc. (DNA) has 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, or BCC. Curis and Genentech had previously disclosed the expected trial initiation in separate January announcements. Under the collaboration agreement, Curis will receive a $6 million cash payment from Genentech following initiation of this pivotal trial.
As part of the trial, Genentech expects to evaluate GDC-0449 in about 100 patients with metastatic or locally advanced 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' existing collaboration agreement with Genentech, Curis provided broad intellectual property rights relating to the Hedgehog pathway, including several classes of proprietary small molecule inhibitors. GDC-0449 was discovered by Genentech through this collaboration, and was jointly validated by the parties through a series of preclinical studies. Genentech is also collaborating with Roche on the clinical development and commercialization of GDC-0449.
Curis said it is eligible to receive cash payments upon successful achievement of certain clinical development and regulatory approval milestones and royalties upon commercialization of GDC-0449.
CRIS is currently trading at $1.26, up $0.04 or 3.28% on the Nasdaq and DNA at $83.95, up $0.95 or 1.14% on the NYSE.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.