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.

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.

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.