Daniel Faga (L) and Joseph Leveque (Mirati)

Weeks in­to CEO shake­up, Mi­rati bids adieu to a pair of C-suit­ers with KRAS drug fil­ing around the cor­ner

Mi­rati is on the cusp of emerg­ing as the sole chal­lenger against Am­gen in the sud­den­ly hot KRAS in­hibitor mar­ket and thinks it has the man to take it across the fin­ish line. But new lead­er­ship of­ten means shake­ups, and now two Mi­rati ex­ecs are be­ing shown the door.

Mi­rati CMO Joseph Lev­eque and Daniel Fa­ga, the biotech’s chief op­er­at­ing of­fi­cer and prin­ci­pal fi­nan­cial of­fi­cer, have both de­part­ed the com­pa­ny as it en­ters the home­stretch for fil­ing its KRAS drug ada­gra­sib with the FDA, Mi­rati re­vealed in an SEC fil­ing Mon­day.

De­tails on the de­par­tures are slim, with Mi­rati not­ing the de­ci­sions on both po­si­tions were made Oct. 28. In Fa­ga’s place, Mi­rati ac­count­ing lead Vick­ie Reed will step in­to the prin­ci­pal fi­nan­cial of­fi­cer role with­out an in­crease in pay, the biotech said.

David Meek

The shake­up comes a lit­tle over a month af­ter Mi­rati ap­point­ed David Meek, a for­mer CEO at Fer­Gene and Ipsen, to the head role, re­plac­ing found­ing CEO Charles Baum.

Meek, who was most­ly re­cent­ly oust­ed from Fer­Gene af­ter the biotech im­plod­ed in spec­tac­u­lar fash­ion ear­li­er this year, came on board right as Mi­rati races to an ex­pect­ed fil­ing for ada­gra­sib this quar­ter, look­ing to keep the heat on Am­gen and its own KRAS in­hibitor Lumakras. The com­pa­ny rolled out Phase II da­ta for ada­gra­sib in non-small cell lung can­cer in Sep­tem­ber it says will serve as the ba­sis for that fil­ing, as well as win­ning mid-stage colon can­cer da­ta at ES­MO21.

Lev­eque had served as CMO at Mi­rati since May 2020, jump­ing over from Syn­thorx, where he served as CMO for a lit­tle un­der two years. Pri­or to that, Lev­eque jumped around be­tween a spate of biotechs and Big Phar­mas, in­clud­ing EMD Serono, Bris­tol My­ers Squibb, Onyx and Am­gen.

Fa­ga had been with Mi­rati since Jan­u­ary 2020, pre­vi­ous­ly hold­ing the chief busi­ness of­fi­cer role at Spark Ther­a­peu­tics for more than three years. He was pre­vi­ous­ly a man­ag­ing di­rec­tor at Cen­ter­view Part­ners and an as­so­ciate at Mer­rill Lynch.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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