David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

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.

Charles Baum

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Who are the women break­ing bar­ri­ers in drug de­vel­op­ment? Nom­i­nate them for End­points' an­nu­al re­port

Today, we’re opening nominations for our fifth annual Women in Biopharma R&D special report.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. We’re looking for big thinkers, scientists, executives and other enterprising women who are breaking barriers in drug development and inspiring the next generation of leaders.

Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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