Fresh out of FerGene collapse, David Meek takes over at Mirati with KRAS drug race leading approval – Endpoints News

In the island world of biotechnology, spectacular failure can sometimes go down in the history of a leader for a long time. But for David Meek, the man behind the recent FerGene implosion, two questionable outings have given way to what could be a great rebound.

Charles Baum

Meek, most recently CEO of FerGene and former head of Ipsen, has become CEO of Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will assume the role of chairman and head of R&D, according to a statement.

Meek, whose future was unclear after FerGene’s dramatic merger earlier this year and the overthrow of its management team, will take over a Mirati business with a lead KRAS inhibitor in preparation for an FDA filing in fourth trimester. 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 repository, as well as colon cancer data at mid-point. course during # ESMO21 this weekend.

Meek was not made available for comment, but in a statement he touted Baum’s work as a founding CEO at the helm of Mirati for the past nine years:

I am honored to lead Mirati and to work alongside the incredibly talented people of this great company to build on what has been accomplished. Chuck effectively led Mirati with an unmatched passion for science, people and, most importantly, patients. With his new appointment, we ensure the continuation of the scientific leadership and patient-centered culture that have made the company successful so far. Mirati has an unprecedented opportunity as we move from developing targeted treatments that transform the way cancer is treated, to providing them to have a meaningful impact on the lives of patients living with cancer.

Prior to FerGene, Meek was CEO of Ipsen and previously was Executive Vice President and President of Oncology at Baxalta, which was acquired by Shire in 2016. Meek also held positions at Endocyte, Novartis and J&J during his 30 years of career.

Meek joined FerGene in December 2019, stepping down as Ipsen during another time of crisis. The company had just a few days earlier received a partial clinical suspension of a rare bone disease program linked to a $ 1.3 billion acquisition of Clementia in early 2019. Meek defended the acquisition, arguing that the lead drug was “Largely derisked,” but the partial suspension and a failed futility analysis that followed closely called that claim into question.

But FerGene would prove to be Meek’s biggest professional challenge after the gene therapy gamer received an FDA CRL for his lead candidate and slowly collapsed. The story of the downfall of biotech was told in an SEC filing in April from competitor Sesen Bio and is the subject of nightmares for life science startups.

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 announced in February this year that it would cut 40% of its staff and a month later it asked the FDA for an extension of its new BLA filing. At some point during this fallout, the entire FerGene management team was ousted, two sources familiar with the matter said. Terminal news, leaving Meek and his long track record in the wind.

FerGene had once been a star with investors, with Phase III winning data for Adstiladrin in hand and potential approval looking very possible. Meek was imported directly from Ipsen to take the therapy to the finish line, with parent company Ferring paying $ 170 million for the effort and Nick Galakatos’ Blackstone Life Sciences an additional $ 400 million.

With all of this in the past, Meek is looking for a fresh start and Mirati will certainly give him another shot at the big leagues. Adagrasib is the closest competitor to Amgen’s KRAS inhibitor, Lumakras, which led the way earlier this year as the first drug of its kind approved by the FDA.

Despite being months behind in the market, Mirati believes her drug has the advantage in terms of clinical efficacy in NSCLC – and a growing case in colon cancer – but the FerGene case proves that nothing is certain until now. ‘that the approval is officially issued.