Peer Re­view: Anil Sing­hal as­sumes lead­er­ship of Adicet Bio; Adap­tive Biotech woos Genen­tech vet as CMO

→ More than a year af­ter Aya Jakobovits abrupt­ly va­cat­ed the CEO of­fice, Adicet Bio has found her per­ma­nent suc­ces­sor just ahead of its first IND. Anil Sing­hal takes over from Don­ald San­tel, the ex­ec­u­tive chair­man who’s been fill­ing the role. An Ab­b­Vie vet, Sing­hal joins the im­munother­a­py com­pa­ny with some fresh biotech ex­pe­ri­ence as ex­ec­u­tive-in-res­i­dence at Canaan Part­ners and CSO of On­coRe­sponse.

Lance Bal­do

→ At the be­gin­ning of this year, Adap­tive Biotech­nolo­gies scored $300 mil­lion in up­front cash from Roche’s Genen­tech for ac­cess to its T cell re­cep­tor iden­ti­fy­ing plat­form. Four months lat­er, the Seat­tle-based biotech has poached one of its top ex­ecs, too. Lance Bal­do, who had a hand in launch­ing Hem­li­bra and Ocre­vus as Genen­tech’s head of US med­ical af­fairs, is com­ing on board as CMO. Aside from its cell ther­a­py plat­form, Bal­do said he’s al­so drawn to Adap­tive’s po­ten­tial in di­ag­nos­ing and mon­i­tor­ing dis­ease of the im­mune sys­tem.

Rob Ian­none

→ CMO Rob Ian­none an­nounced Mon­day that he’s leav­ing Im­munomedics to move to a new ca­reer in Penn­syl­va­nia so that he can be clos­er to his fam­i­ly. His plans come as the com­pa­ny is suf­fer­ing from set­backs and de­par­tures. CEO Michael Pehl left two months ear­li­er af­ter ac­cu­sa­tions of a da­ta in­tegri­ty breach and when the com­pa­ny’s lead drug — the an­it­body drug con­ju­gate IM­MU-132, or sac­i­tuzum­ab govite­can — was re­ject­ed by the FDA.

→ The Cana­di­an pen­ny stock biotech Tril­li­um Ther­a­peu­tics has an­nounced that CEO Niclas Stiern­holm has abrupt­ly re­signed from the com­pa­ny. As they search for a re­place­ment, Robert Kirk­man, the cur­rent chair­man of the board, will act as ex­ec­u­tive chair­man. CSO Bob Uger will as­sume the role of in­ter­im pres­i­dent.

Robin Wash­ing­ton

→ Ahead of re­leas­ing its first-quar­ter re­sults on Thurs­day, Gilead dis­closed yet an­oth­er se­nior ex­ec­u­tive de­par­ture: long­time CFO Robin Wash­ing­ton, who un­veiled plans to ex­it come March 2020. In par­al­lel with the drug­mak­er’s an­nounce­ment on Tues­day, Google’s par­ent com­pa­ny Al­pha­bet un­veiled Wash­ing­ton was set to serve on its board.

Amy Pott

→ As it looks to ex­pand its US foot­print, Swedish rare dis­ease spe­cial­ist So­bi has wooed Amy Pott from Shire to head up its North Amer­i­can op­er­a­tions. Hav­ing over­seen com­mer­cial op­er­a­tions, strat­e­gy and plan­ning for both Shire and Bax­al­ta, Pott joins So­bi af­ter a pe­ri­od of rapid growth — qua­dru­pling its work­force in two years — over­seen by Ra­mi Levin.

Joanne Smith-Far­rell

Joanne Smith-Far­rell is get­ting pro­mot­ed to chief busi­ness of­fi­cer at blue­bird bio. The Mer­ck vet spent the past two years hus­tling deals and bring­ing in new tools and part­ners for the CAR-T and gene ther­a­py pipeline, blue­bird said, while build­ing a team to sup­port the on­col­o­gy fran­chise. She will con­tin­ue to lead that group while as­sum­ing more re­spon­si­bil­i­ty in cor­po­rate de­vel­op­ment and strat­e­gy.

Tama­ra Sey­mour

→ San Diego-based Im­mu­nic $IMUX has ap­point­ed Tama­ra Sey­mour as in­ter­im CFO, bank­ing on her decades of ex­pe­ri­ence in cor­po­rate fi­nance and biotech fundrais­ing as it moves its im­munol­o­gy drugs along the clin­ic. Most re­cent­ly, Sey­mour has been as­sist­ing life sci­ences com­pa­nies with M&A and oth­er needs on an ad­vi­so­ry ba­sis af­ter mul­ti­ple CFO stints at Sig­nal Ge­net­ics, Hemaque­st Phar­ma­ceu­ti­cals, Favrille and more. Im­mu­nic’s lead com­pound is a Phase II drug for ul­cer­a­tive col­i­tis and re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis.

Vivera Phar­ma­ceu­ti­cals has re­cruit­ed Stephen Mc­Col­gan to its mis­sion of har­ness­ing cannabid­i­ol as a non-ad­dic­tive way to man­age pain. “Over the course of my 30-year ca­reer as a sur­geon, I’ve watched opi­oids cause to­tal and com­plete dev­as­ta­tion in pa­tients who had orig­i­nal­ly sought on­ly pain re­lief,” said the new CMO. Based in New­port Beach, CA, Vivera sells a num­ber of CBD for­mu­la­tions.

Maria Koehler

→ Fol­low­ing a brief stint at Bi­cy­cle Ther­a­peu­tics, Maria Koehler has jumped to an­oth­er on­col­o­gy start­up in the Boston area. Re­pare Ther­a­peu­tics drug dis­cov­ery ef­forts are guid­ed by a com­bi­na­tion of DNA dam­age re­sponse and syn­thet­ic lethal­i­ty, aid­ed by CRISPR screen­ing. Koehler is now tasked with test­ing those com­pounds in the clin­ic. Al­so join­ing the com­pa­ny is CFO Kati­na Dor­ton, who had the same role in Avro­bio.

Kati­na Dor­ton

→ Poised to be­gin a piv­otal study, can­cer drug de­vel­op­er Rainier Ther­a­peu­tics (you might re­mem­ber it as Bio­Clin) has scooped Gary Chris­tian­son from Nohla Ther­a­peu­tics, where he was COO. In his new po­si­tion of chief tech­ni­cal of­fi­cer, Chris­tian­son will over­see man­u­fac­tur­ing of vo­fa­tam­ab, an an­ti-FGFR3 drug for blad­der can­cer. Pri­or to Nohla, Chris­tian­son honed his com­mer­cial prod­uct de­vel­op­ment ex­per­tise at Cas­ca­di­an Ther­a­peu­tics (ac­quired by Seat­tle Ge­net­ics) and Corixa (lat­er Glax­o­SmithK­line).

William Gross­man

→ With a new PD-1 in the pipeline and a bio­mark­er al­liance with Stra­ta On­col­o­gy in place, Ar­cus Bio­sciences has wooed the ex­pe­ri­enced I/O vet William Gross­man as their new CMO from Bel­licum. Gross­man is cred­it­ed with a lead­ing role in 50 clin­i­cal tri­als, with a big hand in the de­vel­op­ment of Tecen­triq at Genen­tech. Gross­man will be step­ping in­to an ac­tive, clin­i­cal-stage on­col­o­gy pro­gram, with an on­go­ing Phase I monother­a­py dose-es­ca­la­tion tri­al in pa­tients with ad­vanced tu­mors and oth­er com­bi­na­tion stud­ies.

→ Hav­ing cut back on its urol­o­gy and CNS ef­forts and de­cid­ed to stay laser fo­cused on de­vel­op­ing its lead drug for sleep dis­or­ders, Avadel Phar­ma­ceu­ti­cals $AVDL has hired neu­ro­log­i­cal ex­pert Jor­dan Dubow as CMO. He is now tasked with re­fin­ing clin­i­cal de­vel­op­ment and reg­u­la­to­ry plans for FT218, a treat­ment Avadel hopes to mar­ket as a more con­ve­nient op­tion for ex­ces­sive day­time sleepi­ness and cat­a­plexy in nar­colep­sy pa­tients. Pri­or to this ap­point­ment, Dubow served in a num­ber of sim­i­lar roles at Es­teve, Clin­trex, Marathon and Ab­b­Vie.

Gra­ham Coop­er

Gra­ham Coop­er is leav­ing As­sem­bly Bio­sciences af­ter one year, leav­ing open the CFO and COO roles passed on by co-founder David Bar­rett. Michael Samar, the cur­rent VP of fi­nance and busi­ness op­er­a­tions, will take on the ac­count­ing and cer­tain oth­er tasks as the hep B biotech $ASMB hunts for a new CFO. Mean­while, Aptinyx alum and bio­phar­ma vet David Houck is join­ing as SVP of prod­uct de­vel­op­ment and port­fo­lio man­age­ment to lead a nascent clin­i­cal ef­fort for both HBV and a few Al­ler­gan-part­nered mi­cro­bio­me pro­grams.

→ Fresh off a $100 mil­lion round, Guo-Liang Yu has added a CMO to the trans-Pa­cif­ic team he’s build­ing for Apol­lomics. Fabio Benedet­ti brings a back­ground in on­col­o­gy port­fo­lio man­age­ment from Tai­ho, Geron, Onyx and Mil­len­ni­um. Be­tween Apol­lomics’ Cal­i­for­nia and Chi­na of­fices, Benedet­ti will over­see a pipeline of can­cer com­bi­na­tion ther­a­pies part­nered with a host of Chi­nese biotechs.

CAN­bridge Phar­ma­ceu­ti­cals has tapped sea­soned health­care banker Glenn Has­san for a dual po­si­tion of CFO and chief busi­ness of­fi­cer. Has­san was most re­cent­ly at Chi­na Re­nais­sance Cap­i­tal but pre­vi­ous­ly held in­vest­ment and an­a­lyst roles at Leerink, Citadel and Fi­deli­ty In­vest­ments. The Chi­nese rare dis­ease play­er has al­so en­list­ed for­mer Ed­i­tas Med­i­cines CMO Ger­ald Cox as chief de­vel­op­ment strate­gist and in­ter­im CMO to tem­porar­i­ly re­place May Or­fali, who re­signed for per­son­al rea­sons.

→ In the mid­dle of an IPO at­tempt, Ap­plied Ther­a­peu­tics has named Mark Vi­g­no­la its CFO, tasked with find­ing friends for the com­pa­ny in the fi­nan­cial com­mu­ni­ty. Vi­g­no­la was head of cor­po­rate de­vel­op­ment and in­vestor re­la­tions at In­ter­cept, his first biotech gig af­ter an eq­ui­ty re­search job at Need­ham & Com­pa­ny. The New York-based biotech is de­vel­op­ing a drug for di­a­bet­ic car­diomy­opa­thy as well as di­a­bet­ic pe­riph­er­al neu­ropa­thy.

→ The genome en­gi­neer­ing ex­perts at In­scrip­ta has brought in an Il­lu­mi­na vet on their jour­ney to pop­u­lar­ize their ver­sion of the CRISPR edit­ing plat­form. Ron Mc­Grath’s ti­tle is CFO, but he will like­ly play a big­ger role in scal­ing the com­pa­ny’s in­fra­struc­ture as it pre­pares to com­mer­cial­ize its prod­uct.

Amy­lyx has ap­point­ed Patrick Yerami­an as CMO and Tom Holmes as glob­al head, sup­ply chain for the com­pa­ny. Both be­gan their re­spec­tive po­si­tions in March 2019. Yerami­an pre­vi­ous­ly held the role of con­sult­ing med­ical di­rec­tor for Amy­lyx and Holmes was the se­nior di­rec­tor of ex­ter­nal man­u­fac­tur­ing at Bio­gen for 10 years.

Zymeworks an­nounced Tues­day that the com­pa­ny is ex­pand­ing its glob­al clin­i­cal de­vel­op­ment team by hir­ing three new vice pres­i­dents. The three in­clude: Mark Hol­ly­wood, se­nior vice pres­i­dent of tech­ni­cal and man­u­fac­tur­ing op­er­a­tions; Neil Joseph­son, vice pres­i­dent of clin­i­cal re­search; and Bruce Hart, vice pres­i­dent of reg­u­la­to­ry af­fairs. David Poon was al­so pro­mot­ed to vice pres­i­dent of busi­ness de­vel­op­ment and al­liance man­age­ment with­in the com­pa­ny.

By Am­ber Tong and Kathy Wong.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.