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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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