Japan­ese bil­lion­aire Mik­i­tani takes full con­trol of Rakuten As­pyr­i­an; HOX Ther­a­peu­tics taps Karl Kee­gan as CEO

→ Hav­ing in­fused $150 mil­lion in­to Rakuten As­pyr­i­an weeks ago, Hi­roshi “Mick­ey” Mik­i­tani is step­ping up his con­trol on the biotech he’s been chair­ing since 2016. The Japan­ese bil­lion­aire, known for build­ing a leg­endary e-tail­er from scratch, is tak­ing over the CEO role so that Miguel Gar­cia-Guz­man can con­tin­ue to build the pho­toim­munother­a­py pipeline as CSO and vice chair­man. As the San Diego-based com­pa­ny turns the cor­ner on a Phase III study, it’s al­so ap­point­ed Takashi Toraishi, who was man­ag­ing its Japan of­fices, as COO to over­see clin­i­cal tri­als and com­mer­cial­iza­tion.

→ With Jack­ie Fouse gone to take the reins of Agios, Der­ma­vant Sci­ences — a der­ma­tol­ogy fo­cused unit of Vivek Ra­maswamy’s Roivant Sci­ences — has hired in­dus­try vet­er­an Todd Za­vod­nick as its CEO, as the com­pa­ny pre­pares to be­gin a late-stage tri­al of its lead ex­per­i­men­tal drug, tap­inarof. Za­vod­nick comes with over two decades of ex­pe­ri­ence, hav­ing worked at ZEL­TIQ Aes­thet­ics be­fore it was ac­quired by Al­ler­gan $AGN as well as Gal­der­ma, among oth­er firms.

→ Can­cer biotech HOX Ther­a­peu­tics has ap­point­ed new CEO Karl Kee­gan to lead its en­try in­to the clin­ic. In a ca­reer span­ning prod­uct de­vel­op­ment at SmithK­line Beecham, in­vest­ment an­a­lyst in Lon­don and CFO/cor­po­rate de­vel­op­ment roles at Pharm­ing, Vec­tura and Shield Ther­a­peu­tics, the com­pa­ny notes, he’s amassed sig­nif­i­cant ex­pe­ri­ence in fi­nanc­ing com­pa­nies, busi­ness de­vel­op­ment and cor­po­rate M&A. He is now ex­pect­ed to bring it all to the ta­ble at Guild­ford, UK-based HOX, which is fo­cused on a type of “con­trol” genes cen­tral to em­bryo­ge­n­e­sis called HOX.

→ Se­r­i­al en­tre­pre­neur Pe­ter Suz­dak is out at Rex­ahn Phar­ma­ceu­ti­cals, pass­ing the pres­i­dent and CEO ba­ton to Dou­glas Swirsky. Swirsky, who joined the can­cer drug de­vel­op­er at the be­gin­ning of the year, will car­ry on be­ing CFO. A for­mer in­vest­ment banker, Swirsky was chief ex­ec­u­tive at Gen­Vec for four years un­til it was sold to In­trex­on.

→ Af­ter a decade with Thomas Van­Cott at the helm, ABL is turn­ing a new leaf by pro­mot­ing chief com­mer­cial of­fi­cer Jar­lath Keat­ing to pres­i­dent and CEO. While Keat­ing is a re­cent hire, he’s a vet­er­an of the con­tract re­search and man­u­fac­tur­ing ser­vice in­dus­try, hav­ing held com­mer­cial roles at Mil­li­pore­Sig­ma and tech­ni­cal roles at Lon­za Bi­o­log­ics. His ap­point­ment, the com­pa­ny says, is a “clear re­flec­tion of ABL’s com­mit­ment to a long-term glob­al ex­pan­sion strat­e­gy.”

→ Four new ex­ecs are com­ing on board Flag­ship-seed­ed Sig­ilon Ther­a­peu­tics’ pur­suit of the Holy Grail in di­a­betes: get­ting stem cells to trans­form in­to in­sulin pro­duc­ing pan­cre­at­ic be­ta cells with­out trig­ger­ing a se­vere im­mune re­ac­tion. Deya Cor­zo has joined as CMO af­ter work­ing up her clin­i­cal tri­al mus­cles at So­journix, uniQure, Cel­gene, Take­da and Sanofi/Gen­zyme; Vi­a­Cyte vet Olivia Kel­ly is named VP of islet cell ther­a­py re­search; Martha Rook is jump­ing from Mil­li­pore­Sig­ma to be­come head of man­u­fac­tur­ing; and Vanya Sagar, for­mer­ly of Bio­gen, will be VP of HR.  

Agenus’ $AGEN in-house mid-stage check­points and can­cer vac­cines may still have a long path to com­mer­cial­iza­tion, but the Lex­ing­ton, MA-based biotech wants to be sure it’s ready for it. Jen­nifer Buell is now chief op­er­at­ing of­fi­cer, a role that com­bines all three po­si­tions she’s held in her five years at the com­pa­ny: She has a broad man­date cov­er­ing re­search, clin­i­cal de­vel­op­ment, man­u­fac­tur­ing and com­mer­cial op­er­a­tions. Al­li­son Jeynes-El­lis, bio­phar­ma vet and Avil­lion CEO, has been ap­point­ed as a board di­rec­tor.  

El­liot Ehrich

Kevin For­rest has brought in a new part­ner from 5AM Ven­tures — where he used to be a prin­ci­pal — to his team at Ex­pan­sion Ther­a­peu­tics. El­liot Ehrich, the new­ly mint­ed CMO, had re­cent­ly joined the ven­ture firm af­ter a 17-year run at Alk­er­mes that cul­mi­nat­ed in the top R&D and med­ical role. His ex­pe­ri­ence in dri­ving drug as­sets from ear­ly re­search through ap­proval will be “in­stru­men­tal” for Ex­pan­sion, CEO For­rest says, which is still in dis­cov­ery stage with its RNA-tar­get­ing small mol­e­cule med­i­cines de­signed to treat a set of ge­net­ic dis­eases called ex­pan­sion re­peat dis­or­ders.

→ As Asha Das makes an abrupt de­par­ture from Toca­gen to tend to “un­fore­seen and im­me­di­ate per­son­al mat­ters,” it’s tapped a board mem­ber to fill in as the act­ing CMO. Lori Kunkel, who has three CMO stints from Loxo On­col­o­gy, Phar­ma­cyclics and Pro­te­olix un­der her belt, will take charge of ad­vanc­ing Toca­gen’s Phase III high grade glioma pro­gram and the rest of its pipeline un­til the San Diego-based biotech finds a per­ma­nent hire.

→ Now that As­cle­tis has some­what stead­ied its po­si­tion on the Hong Kong Stock Ex­change — al­beit not an en­vi­able one, cur­rent­ly trad­ing around half of its de­but price — it’s ready to move on with a new CFO on the team. Lin­di Tan brings 15 years of as a health­care an­a­lyst, with stints at SeaTown Hold­ings and Temasek.  

Mer­ck vet Joel Lebowitz has joined Schrödinger as CFO at a time the com­pu­ta­tion­al drug dis­cov­ery shop is dou­bling down on big bio­phar­ma part­ner­ships, marked by a joint ven­ture with WuXi AppTec launched days ago. Lebowitz, who spent much of his time at the phar­ma gi­ant eval­u­at­ing the port­fo­lio and do­ing pipeline val­u­a­tion, will al­so play a key role in busi­ness de­vel­op­ment.

→ Af­ter a decade at now trou­bled Idera, Louis Ar­cu­di is mov­ing on to his next CFO role. The sea­soned ex­ec will be en­ter­ing Mil­len­do Ther­a­peu­tics with Michael Yeh, an alum­ni of So­bi and Bio­gen who’s just been ap­point­ed VP of med­ical af­fairs.

→ Ox­nard, CA-based CURE Phar­ma has tapped ven­ture cap­i­tal­ist Alex Katz to over­see its fi­nan­cial func­tions as CFO. Katz, a for­mer man­ag­ing part­ner for ff Ven­ture Cap­i­tal and Dif­fer­en­tial Ven­ture Part­ners, has been work­ing with the drug de­liv­ery in­no­va­tor as an ad­vis­er.

→ On the heels of a much an­tic­i­pat­ed up­date that keeps the con­tro­ver­sy burn­ing over NK­TR-214/Op­di­vo, Nek­tar $NK­TR an­nounced it has re­cruit­ed Genen­tech vet Wei Lin to spear­head its on­col­o­gy pro­grams. As SVP of clin­i­cal de­vel­op­ment, Lin will have over­sight not just on NK­TR-214 com­bo tri­als but al­so the rest of the I/O pipeline.

→ We fi­nal­ly know where Lisa Suen­nen is head­ed af­ter a sur­pris­ing ex­it from GE Ven­tures.  Man­att Phelps & Phillips, a lead­ing law and con­sult­ing firm with a health-fo­cused branch, an­nounced Suen­nan will head up its dig­i­tal and tech­nol­o­gy busi­ness­es and as well as the firm’s ven­ture cap­i­tal fund from its San Fran­cis­co of­fice.

De­nali CMO Ca­r­ole Ho has tak­en a board seat at Beam Ther­a­peu­tics, the base edit­ing biotech found­ed by CRISPR trail­blaz­ers Feng Zhang, David Liu and J Kei­th Joung.

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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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.

John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”