The Phase 1/2 study will evaluate the safety and efficacy of Mirati's investigational spectrum-selective histone deacetylase (HDAC) inhibitor, mocetinostat, in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). This novel combination will initially be evaluated in patients with non-small cell lung cancer (NSCLC), with the potential to explore additional indications in the future.
Mocetinostat selectively inhibits Class I HDAC enzymes, which has the potential to enhance the positive effect of checkpoint inhibitors, such as durvalumab, on tumor immunity, while durvalumab is designed to counter the tumor's immune-evading tactics by blocking a signal that helps tumors avoid detection.
"There is a growing body of evidence that mocetinostat may enhance the efficacy of immune checkpoint inhibitors such as PD-L1 antibodies," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "Mocetinostat selectively targets specific HDACs that may increase the efficacy of durvalumab in patients with non-small cell lung cancer, as well as other tumor types. We look forward to working with MedImmune on this novel combination to potentially improve outcomes for patients."
"The collaboration with Mirati is yet another example of our combination-focused immuno-oncology strategy and our comprehensive approach in lung cancer as a key disease area," said David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune. "We continue to follow the scientific evidence to explore novel combination treatments to meet unmet patient need, with durvalumab as the cornerstone."
Under the terms of the agreement, Mirati will conduct and fund the initial Phase I/II clinical trial, which is expected to start in 2016, and MedImmune will supply durvalumab for the trial. The parties have established a Joint Steering Committee to oversee the trial. In the event that the initial clinical trial demonstrates positive results, MedImmune will have an exclusive period of time in which to negotiate a commercial license for the combination in this indication.