Pharmaceutical Business review

Curis licenses GDC-0917 from Genentech

Curis president and chief executive officer Dan Passeri said the GDC-0917 agreement adds depth to current pipeline of proprietary targeted anti-cancer agents and further solidifies the company’s relationship with Genentech Partnering.

"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," Passeri added.

Genentech has also completed GDC-0917 phase I clinical trial with 42 people receiving daily oral doses of GDC-0917 for two weeks, followed by a one week rest period.

Genentech Partnering vice president James Sabry said, ”We have been impressed with the results of our recently completed Phase I clinical trial and look forward to Curis’ further development of GDC-0917."

Curis, which has designated GDC-0917 as CUDC-427, intends further clinical development of CUDC-427, both as a single agent as well as in a Phase I clinical trial in combination therapy, which upon successful result would advance to phase II combination clinical studies.

As part of the license agreement, Curis will have exclusive responsibility to research, develop, manufacture and commercialize CUDC-427 and will also pay Genentech $9.5m up-front license payment and technology transfer costs.

The agreement also facilitates Genentech for milestone payments upon the first commercial sale in certain territories and royalties on net sales of CUDC-427.

In addition to the agreement, Curis has also stated that, upon certain closing conditions, it will enter into a $30m debt transaction secured with certain future Erivedge royalties, which will be used to develop Curis’ proprietary programs, including CUDC-427.

CUDC-427 is an orally bioavailable small molecule that activates tumor cell apoptosis by selectively antagonizing IAP proteins while IAP proteins are a family of functionally and structurally related proteins which include X-linked IAP, cellular IAPs (cIAP1 and cIAP2) and melanoma IAP.

Curis has also updated on clinical status regarding CUDC-101, CUDC-907 and Debio 0932, which is being developed by its licensee Debiopharm.