David Meek­er starts a new biotech chap­ter in his ca­reer; Sam Kulka­rni takes the helm at CRISPR

David Meek­er left Gen­zyme last April af­ter a 23-year run, in­clud­ing six years as pres­i­dent af­ter Sanofi stepped in to buy the land­mark biotech six years ago. Five months lat­er, af­ter adding a string of biotech board po­si­tions to his sched­ule, Meek­er has land­ed his next big gig in biotech run­ning KSQ Ther­a­peu­tics in Cam­bridge, MA. At KSQ, he says, you can start an ex­per­i­ment us­ing cut­ting edge tech­nol­o­gy and no bias about out­comes. With CRISPR,“we can study all 20,000 genes in the genome across a mul­ti­tude of dis­ease mod­els and find out which of those tar­gets has the biggest im­pact in mod­u­lat­ing the dis­ease. We can do it one shot, 20,000 genes at a time.”

Sam Kulka­rni

→ Af­ter steer­ing CRISPR Ther­a­peu­tics to an IPO last year as the last of the big three gene edit­ing com­pa­nies to make the leap in­to the pub­lic mar­kets, found­ing CEO Rodger No­vak is step­ping down and hand­ing the reins over to the orig­i­nal chief busi­ness de­vel­op­ment of­fi­cer, Samarth Kulka­rni. There’s no spe­cif­ic rea­son giv­en for No­vak’s de­par­ture, oth­er than the gener­ic “per­son­al rea­sons” of­ten cit­ed dur­ing these kinds of change­ups. No­vak is stay­ing on the board.

Shafique Vi­rani, a busi­ness de­vel­op­ment ex­ec at Roche/Genen­tech, has been named the new CEO of Navire Phar­ma. Part­ner­ing with MD An­der­son, the biotech will work on in­hibit­ing SHP2 in fight­ing can­cer tu­mors. “Navire’s com­pounds po­tent­ly bind SHP2 and pre­vent ac­ti­va­tion of the pro­tein, block­ing its abil­i­ty to pro­mote tu­mor growth,” said Vi­rani. Bridge­Bio is bankrolling the start­up to the tune of $30 mil­lion.

Loan Hoang-Sayag is ex­it­ing her post as CMO at Cel­lec­tis, ef­fec­tive im­me­di­ate­ly. Math­ieu Si­mon, the COO/EVP of the im­munother­a­py com­pa­ny, will be step­ping in as the in­ter­im.

An­ge­lo Moess­lang has joined In­Gen­eron as their new CEO. For­mer­ly, Moess­lang was the CFO at Fre­se­nius Med­ical Care North Amer­i­ca, where he worked his way up start­ing in 1995.

Halozyme Ther­a­peu­tics‘ chief op­er­at­ing of­fi­cer Mark Ger­gen is leav­ing to “pur­sue pro­fes­sion­al op­por­tu­ni­ties out­side the Com­pa­ny.”

Sumi­ta Ray is the new gen­er­al coun­sel of Calithera Bio­sciences.

→ Ad­verum Biotech­nolo­gies has added Lin­da Neu­man as VP of clin­i­cal de­vel­op­ment. She hails from Sune­sis Phar­ma­ceu­ti­cals.

→  Ste­fan Oel­rich worked his way up and is now the ex­ec­u­tive vice pres­i­dent of Sanofi’s di­a­betes & car­dio­vas­cu­lar unit.

Ganesh Kaun­dinya has been pro­mot­ed to the COO/CSO gig at Mo­men­ta. He is one of the co-founders of the Cam­bridge, MA-based com­pa­ny.

Im­muno­core has ap­point­ed An­drew Hotchkiss as their new chief com­mer­cial of­fi­cer. Pre­vi­ous­ly, he worked at Eli Lil­ly, be­gin­ning in ’96.

→  Mar­go Heath-Chiozzi is now SVP of reg­u­la­to­ry af­fairs at Celldex Ther­a­peu­tics.

→  Amit Shah is the CFO at Ma­ri­na Biotech.

Con­tra­Fect’s new COO is Lisa Ric­cia­r­di.

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.

Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

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.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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NIH re­jects an­oth­er at­tempt to 'march-in' on Astel­las' prostate can­cer drug over ex­ces­sive price

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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