Fresh off FerGene's meltdown, David Meek takes over at Mirati with lead KRAS drug racing to an approval
In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.
Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.
Meek, whose future was unclear after FerGene melted down in spectacular fashion earlier this year and ousted its leadership team, will take over a Mirati outfit with a lead KRAS inhibitor prepping for an FDA filing in Q4. The company rolled out Phase II data for adagrasib in non-small cell lung cancer earlier Monday morning that it says will serve as the basis for that filing, as well as winning mid-stage colon cancer data at this weekend’s #ESMO21.
Meek wasn’t made available for comment, but in a statement he touted Baum’s work as founding CEO in leading Mirati for the past nine years:
I am honored to lead Mirati and work alongside the incredibly talented people of this great company to build on what has been accomplished. Chuck has effectively led Mirati with an unrivaled passion for the science, people and most importantly, the patients. With his new appointment, we ensure the continuation of the scientific leadership and patient-centric culture that have made the company successful thus far. Mirati has an unprecedented opportunity as we transition from developing targeted treatments that transform the way cancer is treated, to also delivering them to meaningfully impact the lives of patients living with cancer.
Prior to FerGene, Meek was CEO at Ipsen and previously was an executive VP and president of oncology at Baxalta, which was acquired by Shire in 2016. Meek also held roles at Endocyte, Novartis and J&J over the course of his 30-year career.
Meek joined FerGene in December 2019, checking out from the Ipsen job during another moment of crisis. The company had just days before received a partial clinical hold on a rare bone disease program tied to a $1.3 billion acquisition of Clementia in early 2019. Meek championed that acquisition, arguing the lead drug was “largely derisked,” but the partial hold and a failed futility analysis that closely followed put that claim into question.
But FerGene would prove Meek’s biggest professional challenge after the gene therapy player received a CRL from the FDA for its lead candidate and slowly crumbled. The story of the biotech’s downfall was told in a SEC filing in April from a competitor, Sesen Bio, and is the stuff of nightmares for life sciences startups.
Back in May 2020, FerGene received a CRL for lead therapy Adstiladrin, a gene therapy for bladder cancer, based on CMC issues, Sesen said. The company in February of this year announced it would cut 40% of its staff and a month later asked the FDA for an extension on its BLA re-filing. At some point during that fallout, the entire leadership team at FerGene was ousted, two sources familiar with the matter told Endpoints News, leaving Meek and his lengthy track record in the wind.
FerGene had once been a star with investors, with winning Phase III data for Adstiladrin in hand and a potential approval looking very possible. Meek was imported directly from Ipsen to get the therapy over the finish line with parent company Ferring ponying up $170 million for the effort and Nick Galakatos’ Blackstone Life Sciences chipping in another $400 million.
With all that in the past, Meek is looking for a fresh start and Mirati will certainly afford him another shot at the big leagues. Adagrasib is the closest competitor to Amgen’s own KRAS inhibitor, Lumakras, which broke ground earlier this year as the first drug of its kind approved by the FDA.
Despite being months behind the market, Mirati thinks its drug has the upper hand in terms of clinical efficacy in NSCLC — and a growing case in colon cancer — but the FerGene case proves that nothing is certain until the approval officially comes in.