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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Chris Sheldon, AstraZeneca's former VP and head of investor relations

As­traZeneca files law­suit against for­mer ex­ec as he jumps to GSK

AstraZeneca and GSK are once again wrangling over talent.

The British pharma giant has filed suit against former VP and head of investor relations Chris Sheldon as he prepares to start a new job at its rival next month. AstraZeneca argued in a London court filing that Sheldon would be violating a non-compete agreement, which he was paid more than $774,000 in shares to sign back in 2021, Bloomberg reported.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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