Jim Robin­son takes over the reins at Urovant; Car­los Cam­poy moves to Cy­tomX

Jim Robin­son

→ Af­ter near­ly a year as pres­i­dent and COO at Paragon Bio­sciences, Jim Robin­son has jumped to Urovant Sci­ences, where he will be pres­i­dent and CEO of the urol­o­gy-fo­cused biotech, suc­ceed­ing found­ing CEO Kei­th Katkin. Robin­son will con­tin­ue as a mem­ber of Urovant’s board of di­rec­tors. His pre­vi­ous stops in­clude Alk­er­mes as pres­i­dent and COO and a num­ber of po­si­tions at Astel­las and Scher­ing-Plough Phar­ma­ceu­ti­cals.

Car­los Cam­poy

→ At the same time as an $80 mil­lion part­ner­ship with Astel­las, Cy­tomX has re­cruit­ed Eli Lil­ly vet Car­los Cam­poy as SVP and CFO. Most re­cent­ly, Cam­poy served as CFO of Alder Bio­Phar­ma­ceu­ti­cals, help­ing com­plete its $2 bil­lion sale to Lund­beck. Pri­or to that, Cam­poy was VP of fi­nance, in­ter­na­tion­al at Al­ler­gan.

Bris­tol My­ers‘ for­mer top deal­mak­er Paul Bion­di — who’s cur­rent­ly serv­ing as an ex­ec­u­tive part­ner at Flag­ship Pi­o­neer­inghas joined the board of di­rec­tors at Seres Ther­a­peu­tics, suc­ceed­ing Flag­ship CEO Noubar Afeyan who’s step­ping down.

→ UK-based Im­mune Reg­u­la­tion has wooed the for­mer CEO of SteadyMed Ther­a­peu­tics (ac­quired by Unit­ed Ther­a­peu­tics) Jonathan Rig­by to the helm of their com­pa­ny as CEO. Rig­by co­found­ed Zo­genix and ear­li­er in his ca­reer served at Mer­ck and Bris­tol My­ers Squibb.

→ Shang­hai-based EpimAb Bio­ther­a­peu­tics has en­list­ed Xinyi “David” Gu as CFO. Gu makes the hop over from Mil­len­ni­um Man­age­ment, and pri­or to that served at Jef­feries as VP and glob­al phar­ma­ceu­ti­cal eq­ui­ty re­search an­a­lyst. In ad­di­tion, Gu has held a post at McK­in­sey & Com­pa­ny.

David Gu EpimAb

→ Af­ter bag­ging $26 mil­lion in fund­ing and earn­ing fast track des­ig­na­tion for its lead drug can­di­date, gene ther­a­py com­pa­ny Gen­prex has re­cruit­ed Michael Red­man as EVP and COO and Cather­ine Vaczy as EVP and chief strat­e­gy of­fi­cer. Red­man was the for­mer CEO and pres­i­dent of On­col­ix for more than a decade. Pri­or to On­col­ix he served in posts at Bone Med­ical, Opexa Phar­ma­ceu­ti­cals and Zon­a­gen, among oth­ers. Vaczy was a co-founder of NeoStem (now Cal­adrius Bio­sciences) and served at Im­Clone Sys­tems (ac­quired by Eli Lil­ly).

Men­lo Ther­a­peu­tics has tapped An­drew Saik as CFO and trea­sur­er. Saik will be based at the com­pa­ny’s head­quar­ters at Bridge­wa­ter, New Jer­sey. Most re­cent­ly, Saik served as CFO of PDS Biotech­nol­o­gy. Pri­or to that, he was CFO at Ver­tice Phar­ma and Aux­il­i­um Phar­ma­ceu­ti­cals — help­ing in the $2.6 bil­lion sale of the com­pa­ny. His pre­vi­ous ex­pe­ri­ence in­cludes stints at En­do Health So­lu­tions and Valeant Phar­ma­ceu­ti­cals.

Lisa Ro­jk­jaer has joined Virac­ta Ther­a­peu­tics as CMO, ef­fec­tive May 1. Pri­or to her ap­point­ment at the pre­ci­sion on­col­o­gy com­pa­ny, Ro­jk­jaer was CMO at Oslo-based Nordic Nanovec­tor and glob­al clin­i­cal pro­gram head, on­col­o­gy glob­al de­vel­op­ment at No­var­tis. Among her re­spon­si­bil­i­ties will be steer­ing Virac­ta’s lead pro­gram to­ward reg­u­la­to­ry ap­provals for Ep­stein-Barr virus (EBV) pos­i­tive lym­phomas.

Lisa Ro­jk­jaer

→ Af­ter wel­com­ing Shafique Vi­rani last week as chief cor­po­rate de­vel­op­ment of­fi­cer, AI biotech Re­cur­sion has added Michael Sec­o­ra as CFO. Sec­o­ra joins the com­pa­ny af­ter a decade of ser­vice at Lau­ri­on Cap­i­tal, where he served as man­ag­ing di­rec­tor and head of cap­i­tal mar­kets and ven­ture. Near the same time as Vi­rani’s ap­point­ment last week, for­mer Cel­gene ex­ec Robert Her­sh­berg was ap­point­ed to the com­pa­ny’s board of di­rec­tors. Her­sh­berg served as Cel­gene’s CSO and EVP and head of busi­ness de­vel­op­ment and glob­al al­liance.

→ Bel­gian or­tho­pe­dics-fo­cused biotech Bone Ther­a­peu­tics has a new CBO, nam­ing Ste­fanos Theo­haris to the post. With ex­pe­ri­ence in the cell and gene ther­a­py are­na, Theo­haris was for­mer­ly SVP at Cell Med­ica and CBO at apceth GmbH.

Pravin Dugel has been ap­point­ed EVP and chief strat­e­gy and busi­ness of­fi­cer of IVER­IC bio, which con­cen­trates on treat­ment for reti­nal dis­eases. Dugel brings more than 25 years of ex­pe­ri­ence in the field to the New York bio­phar­ma and has al­so been man­ag­ing part­ner at Reti­nal Con­sul­tants of Ari­zona and the Reti­nal Re­search In­sti­tute.

I-Mab has se­lect­ed Gi­gi Feng to be its VP, glob­al head of cor­po­rate com­mu­ni­ca­tions start­ing on April 20. She will over­see all com­mu­ni­ca­tions at the Chi­na-based bio­phar­ma, which cen­ters on nov­el or high­ly dif­fer­en­ti­at­ed bi­o­log­ics to treat dis­eases with sig­nif­i­cant un­met med­ical needs. Feng pre­vi­ous­ly had com­mu­ni­ca­tions roles at Am­gen and Sanofi.

Meenu Chhabra, the CEO and pres­i­dent of Pro­teosta­sis Ther­a­peu­tics, has hopped aboard the board of di­rec­tors at Va­som­mune Ther­a­peu­tics — a com­pa­ny work­ing on a treat­ment for Covid-19/pathogen-in­duced ARDS.

→ NASH biotech 89bio has wel­comed Steven Altschuler as chair­man to its board of di­rec­tors. Altschuler serves as man­ag­ing di­rec­tor of health­care ven­tures at Ziff Cap­i­tal Part­ners.

→ Im­muneer­ing — whose cur­rent pipeline fo­cus­es on dis­eases such as can­cer cachex­ia and metas­ta­sis — has brought on three new ad­di­tions to its sci­en­tif­ic ad­vi­so­ry board. Daniel Ahn, di­rec­tor of the GI On­col­o­gy Trans­la­tion­al Re­search Work­ing Group; Mitesh Bo­rad, di­rec­tor of the can­cer cell, gene and virus ther­a­py lab at the Mayo Clin­ic Cen­ter for In­di­vid­u­al­ized Med­i­cine; and Bi­jan Ne­jad­nik, the CMO and head of re­search at San­Bio.

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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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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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.”