Peer Re­view: For­mer FDA Com­mish Califf will split his time be­tween Ver­i­ly and Duke

→ Af­ter a lit­tle over a year and a half at Al­pha­bet’s Ver­i­ly, neu­ro­sci­en­tist Dr. Thomas In­sel is join­ing the mys­te­ri­ous com­pa­ny’s ex­o­dus of tal­ent and call­ing it quits. In­sel ran the Na­tion­al In­sti­tute of Men­tal Health pri­or to his gig at Ver­i­ly. These days you can find him as the pres­i­dent and co-founder at a start­up called Mind­strong Health, which “has de­vel­oped and patent­ed a bio­mark­er pan­el that mea­sures brain func­tion from in­ter­ac­tion pat­terns cap­tured pas­sive­ly and con­tin­u­ous­ly from hu­man-com­put­er in­ter­faces found in ubiq­ui­tous mo­bile tech­nol­o­gy.”

Robert Califf

En­ter­ing the Ver­i­ly realm is Robert Califf. The ex-FDA com­mis­sion­er pre­vi­ous­ly worked with Ver­i­ly head An­dew Con­rad be­fore to head­ing up the agency. He’s al­so back at Duke Uni­ver­si­ty. “Af­ter con­clud­ing what has been an amaz­ing ex­pe­ri­ence as FDA Com­mis­sion­er, I’m ex­cit­ed to turn to a new ca­reer with Ver­i­ly and Duke Uni­ver­si­ty,” says Califf in his Ver­i­ly blog post.

→  Al­most ex­act­ly four years af­ter be­ing named per­ma­nent chief sci­en­tif­ic of­fi­cer at Bio­gen, Spy­ros Ar­ta­va­nis-Tsakonas has qui­et­ly left the com­pa­ny. The cell bi­ol­o­gy spe­cial­ist has been a pro­fes­sor at Har­vard Med­ical School since 1999. And now he’s head­ed back with fund­ing from Bio­gen on new re­search in­to neu­rode­gen­er­a­tive dis­eases. The big biotech gets an op­tion on li­cens­ing new tech from his lab in ex­change for the fund­ing.

→  For­mer Sarep­ta CEO Chris Garabe­di­an has won $15 mil­lion from some loy­al back­ers at Per­cep­tive Ad­vi­sors to es­tab­lish Xon­toge­ny, which promis­es to guide biotech star­tups through the first crit­i­cal stage of de­vel­op­ment lead­ing to proof-of-con­cept da­ta. Garabe­di­an is run­ning the show and he’s now re­cruit­ing a team.

Patrick Am­stutz has made the jump from in­ter­im CEO to the re­al deal. Am­stutz helmed Mol­e­c­u­lar Part­ners af­ter Chris­t­ian Zahn left the job late last year.

Ox­itec CEO Ha­dyn Par­ry is join­ing the moth­er ship. Par­ry has been bumped up to VP of cor­po­rate de­vel­op­ment, Eu­rope, the Mid­dle East, and Africa for In­trex­on. Look for Mark Carnegie-Brown to be in charge of Ox­itec as the new CEO.

→  Is­rael’s Al­co­bra said that CEO Yaron Daniely is step­ping down to head up the tech trans­fer arm at He­brew Uni­ver­si­ty.

Cy­tomX is shuf­fling the deck, with Bob Goetz ex­it­ing the CFO po­si­tion of the South San Fran­cis­co, CA-based biotech to “pur­sue new op­por­tu­ni­ties.” De­ban­jan Ray is now the new CFO and head of cor­po­rate de­vel­op­ment. “De­ban­jan has been in­stru­men­tal to Cy­tomX’s busi­ness suc­cess, in­clud­ing struc­tur­ing and ex­e­cut­ing col­lab­o­ra­tions that have re­sult­ed in more than $300 mil­lion in up­front and mile­stone pay­ments to date and to­tal po­ten­tial deal val­ue in ex­cess of $5 bil­lion,” said CEO Sean Mc­Carthy.

→ Ac­tini­um CEO Kaushik J. Dave and Chief Tech­nol­o­gy Of­fi­cer Dra­gan Ci­cic have both re­signed from the com­pa­ny

 

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.