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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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