Oncology company, Mirati Therapeutics, Inc. has just signed an agreement with international biologics research and development AstraZeneca subsidiary, MedImmune to collaborate on a Phase I/II clinical trial to determine the safety and efficacy of the former’s pipeline spectrum-selective histone deacetylase (HDAC) inhibitor, mocetinostat, combined with MedImmune’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736).
The experimental combination treatment will initially be tested on patients with non-small cell lung cancer (NSCLC). The possibility of exploring other indications will depend on study results. Mirati’s mocetinostat works by inhibiting Class I HDAC enzymes, which leads to the potentiation of checkpoint inhibitors, such as durvalumab, on tumor immunity.
“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.”
The agreement stipulates that Mirati will be responsible for conducting and funding the first Phase I/II clinical trial, which the company expects to launch in 2016. MedImmune will fulfill the supply of durvalumab for the trial. The two companies have also created a Joint Steering Committee to manage the trial. In the event of arriving at favorable results, MedImmune will have the opportunity to negotiate commercial licensing for the resulting combination for NSCLC.
The EC approval is the first treatment advance within the European Union (EU) for NSCLC in more than a decade, allowing the marketing of Nivolumab BMS in all 28 EU Member States.
