Mirati Therapeutics Inc. (NASDAQ:MRTX) And Bristol-Myers Squibb Co. (NYSE:BMY) have entered into a clinical alliance. The two have agreed to collaborate in the assessment of the combination of sitravatinib and nivolumab. The assessment is taking place in Mirati’s planned Phase 3 trial before it can move to Phase 3 pivotal trial.
Sitravatinib is an inhibitor with the potential to inhibit receptor tyrosine kinases (RTKs) such as TAM family receptors (TYRO3, Axl, Mer). It is also an immuno-oncology agent under evaluation in combination with nivolumab. Over and above, it is undergoing evaluation as a single agent in a Phase 1b expansion clinical trial. The trial highlights the importance of enrolling patients suffering from tumors harboring particular mutations in the CBL protein.
Expectations that the trial should result in a new drug application (NDA)
There is high anticipation that the trial, which will engage randomized patients will result in a new drug application (NDA). The President and CEO of Mirati, Charles Baum, supports the anticipation citing, “Our Phase 2 clinical trial of sitravatinib plus nivolumab in patients with checkpoint refractory NSCLC has shown promising activity and a well-tolerated safety profile.”
Sitravatinib is a treatment for tumors, which have progressed as a result of treatment with a platinum-containing regimen. There will be an interim analysis of the trial, and it will gauge the overall response rate (ORR). The analysis follows guidance from Mirati’s FDA.
Meanwhile, the collaboration is likely to endorse the potential of sitravatinib. The endorsement will be an added advantage to Mirati in its development and expansion plans of pre-clinical programmes. The terms of collaboration dictate that Mirati will provide the financial sponsorship of the trial while Bristol-Myers provides nivolumab but at no cost.
Mirati has added a new appointee to its leadership team
The oncology company has hired Maya Martinez-Davis who will join the Company’s Board of Directors. The incumbent reportedly has sound experience having developed emerging markets in over 14 countries. According to Baum, she a seasoned pharmaceutical executive and will play a key role in guiding the company’s continued business growth. Over and above, she heads BioPharma Latin America for Merck KGaA, in Germany.