Mirati is gearing up to move a hotly anticipated KRAS inhibitor to regulatory filings, and now the biotech will have a new industry veteran at the helm to complete the work.
The biotech has named David Meek as CEO, an industry veteran who formerly led rare disease-focused Ipsen and gene therapy company FerGene. Meek will take over as CEO immediately, Mirati said Monday. Founder Charles Baum, M.D., Ph.D. will transition to the role of president and head of R&D. Meek will also gain a seat on the board of directors.
Meek enters the Mirati office as the small biotech works quickly to build a strong clinical trial record for the KRAS inhibitor adagrasib. The company is trailing Big Pharma Amgen, which gained a coveted FDA nod for the competing drug Lumakras back in May.
With two clinical trial readouts on adagrasib presented this week at the European Society for Medical Oncology Congress 2021, the San Diego biotech is getting closer to the finish line.
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FerGene ran into some snags trying to move a gene therapy to approval in bladder cancer during Meek's tenure. The biotech had asked for more time to resubmit an application in March, and Meek's time as CEO ended the next month, according to his LinkedIn profile. He served for about a year and a half.
Prior to that, Meek jumped ship from Ipsen just weeks after the French biotech ran into its own challenges with the FDA. The regulatory agency placed two trials for a rare disease drug on partial clinical hold and Meek quickly headed toward the exit to lead FerGene after about three and a half years.
Now, the 30-year biopharma veteran takes hold of the reins at Mirati, which is prepping adagrasib for a filing in the fourth quarter. Data from a phase 2 study evaluating the drug in patients with advanced non-small-cell lung cancer could be "potentially registration-enabling," the biotech said in a separate release Monday.
The KRAS drug also showed a higher overall response rate than Lumakras in patients with colorectal cancer, according to a Sunday ESMO presentation. Lumakras was approved in lung cancer in May but has not shown the same level of promise in colorectal cancer, so Mirati could carve out a niche in that indication.