Curis, a Lexington, Mass.-based drug development company focused on targeted small molecule drug candidates for cancer treatment, has licensed from San Francisco-based Genentech, a member of the Roche Group, exclusive worldwide rights for the development and commercialization of GDC-0917, a small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins.
Curis will have the sole right and responsibility for all research, development, manufacturing and commercialization activities related to CUDC-427. Curis will pay Genentech $9.5 million for an up-front license payment and technology transfer costs. In addition, Genentech is entitled to receive milestone payments upon the first commercial sale of CUDC-427 in certain territories and royalties on net sales of CUDC-427.
"We are very pleased to have entered into this agreement for GDC-0917, which adds depth to our current pipeline of proprietary targeted anti-cancer agents and further solidifies our relationship with our partner Genentech," said Dan Passeri, president and CEO, Curis. "Importantly, we anticipate that the $30 million non-dilutive royalty financing transaction that we also announced this morning will provide us with sufficient capital to progress GDC-0917 and our other programs to important development milestones."
Genentech recently completed a phase I clinical trial of GDC-0917, in which 42 people received daily oral doses of GDC-0917 for two weeks, followed by a one week rest period. This 21-day cycle is repeated until disease progression or study discontinuation for any other reason. The primary endpoints of the study include evaluating the safety and tolerability and the pharmacokinetics of GDC-0917 in people with solid tumors or lymphoma and determining the maximum-tolerated dose and a potential recommended dose for further clinical studies. Secondary endpoints include a preliminary assessment of anti-tumor activity of GDC-0917 and evaluating pharmacodynamic markers.
"The results of the phase I study with GDC-0917 have been encouraging," said principal investigator Anthony Tolcher, M.D., director of clinical research at South Texas Accelerated Research Therapeutics (START) in San Antonio, Texas. "We believe that IAP inhibition could prove to be an important approach in cancer therapy and we look forward to working with Curis in upcoming clinical studies of this exciting molecule.”
Curis has designated GDC-0917 as CUDC-427 and plans to continue the further clinical development of CUDC-427, both as a single agent as well as in a phase I clinical trial in combination therapy, which if successful would enable Curis to advance to phase II combination clinical studies.