Ex-Ax­o­vant COO Mar­i­on Mc­Court lands at Re­gen­eron; GT Bio­phar­ma el­e­vates Shawn Cross to CEO in ex­ec reshuf­fle

Mar­i­on Mc­Court

→ While our eyes were fixed on CEO David Hung’s de­par­ture from strug­gling Ax­o­vant, COO Mar­i­on Mc­Court al­so qui­et­ly jumped ship — to Re­gen­eron $REGN. The com­pa­ny an­nounced Mon­day (the same day Mc­Court’s res­ig­na­tion from Ax­o­vant was made pub­lic) that it has ap­point­ed her as SVP and head of com­mer­cial. The ap­point­ment filled a va­can­cy left by Robert Ter­i­fay, who re­signed last month in the mid­dle of a med­ical leave and plans to re­tire in Ju­ly. A sea­soned ex­ec with foot­prints at As­traZeneca, Am­gen and Medi­va­tion, Mc­Court will lead the com­mer­cial­iza­tion for both ap­proved med­i­cines and de­vel­op-stage pipeline.

Michael Nolte is the new CEO at clin­i­cal tech­nol­o­gy and ser­vice provider Brack­et, suc­ceed­ing Jeff Kin­nell. Nolte was for­mer­ly the CEO of In­flu­ence Health, which makes soft­ware for health care or­ga­ni­za­tions.

→ An am­bi­tious GT Bio­phar­ma has reshuf­fled its ex­ec­u­tive lead­er­ship in a strate­gic tran­si­tion: cur­rent pres­i­dent and COO Shawn Cross will take the helm as chair­man and CEO, while co-founder and ex-CEO Kath­leen Clarence-Smith con­cen­trates on the neu­rol­o­gy di­vi­sion. An­tho­ny Catal­do, an­oth­er co-founder who cham­pi­oned the com­pa­ny’s on­col­o­gy pro­file, will re­main on the board and be­come a con­sul­tant. An in­vest­ment banker by train­ing, Cross has tall or­ders ahead of him, in­clud­ing lead­ing the Wash­ing­ton, DC-based biotech through a list­ing on Nas­daq, at­tract­ing in­sti­tu­tion­al in­vest­ment and an­a­lyst cov­er­age, and guid­ing the first clin­i­cal tests of a trispe­cif­ic AD­CC NK cell en­gager.

→ As Ar­a­digm $ARDM con­tends with the af­ter­math of a dis­as­trous reg­u­la­to­ry jour­ney, it has let go of three of its top ex­ec­u­tives in an ap­par­ent mea­sure to cut costs. CEO Ig­or Gon­da, CMO Juer­gen Froehlich and CFO Nan­cy Peco­ta have re­signed from all of their po­si­tions at the trou­bled biotech. John Siebert, cur­rent chair­man of the board, will step in as ex­ec­u­tive chair­man and in­ter­im prin­ci­pal ex­ec­u­tive of­fi­cer. If Ar­a­digm wants an­oth­er chance at the FDA for its in­haled an­tibi­ot­ic Lin­haliq, which it in­di­cat­ed it would like to do, it would need fresh cash to fu­el a whole new PhI­II pro­gram.

→ Lit­tle Arc­turus $ARCT is go­ing through a dra­mat­ic shake­up this month. Short­ly af­ter news that its founder and CEO Joseph Payne was boot­ed from the com­pa­ny (with board mem­bers al­leged­ly con­spir­ing on his ouster), Arc­turus is now los­ing an­oth­er top ex­ec­u­tive. The com­pa­ny’s chief sci­en­tif­ic of­fi­cer and chief op­er­at­ing of­fi­cer Pad Chivuku­la is step­ping down, the com­pa­ny said in a state­ment. That’s in­ter­est­ing, con­sid­er­ing Payne re­cent­ly not­ed that both he and Chivuku­la had been left out of par­tic­i­pa­tion in board dis­cus­sions and votes. Chivuku­la will stay on as sci­en­tif­ic ad­vi­sor to Arc­turus, the com­pa­ny said. The news comes in con­junc­tion with a new state­ment filed with the SEC not­ing that Payne, the ex-CEO, is de­mand­ing an “ex­tra­or­di­nary meet­ing” of the board to vote on an ouster of his own de­sign. In the let­ter, he calls for the boot to four com­pa­ny di­rec­tors — Stu­art CollinsonCraig Wil­lettDaniel Gef­fken, and David Shapiro — who he says en­gaged in an in­trigue that vi­o­lat­ed the rules es­tab­lished by the Is­raeli laws that gov­ern its op­er­a­tions. Payne is sug­gest­ing four new di­rec­tors take their place, in­clud­ing some of the biggest names in San Diego biotech: Mag­da Mar­quetPe­ter Far­rellAn­drew Sas­sine, and James Bar­low. Mar­quet, founder and co-chair of Althea Tech­nolo­gies, is a well-known in­dus­try ex­ec­u­tive who’s a bit of a leg­end in San Diego. And Far­rell, is the founder and for­mer long-term CEO and cur­rent chair­man of ResMed, one of the largest med­ical de­vice com­pa­nies in San Diego.

Jef­frey Goater

→ Sur­face On­col­o­gy has pro­mot­ed its BD chief to run the com­pa­ny. Jef­frey Goater is tak­ing the helm of the Cam­bridge, MA-based biotech, fo­cused on new drugs tar­get­ing CD47 and CD73 in the tu­mor mi­croen­vi­ron­ment. He’s re­plac­ing As­traZeneca vet Detlev Bin­iszkiewicz, who was re­cruit­ed a lit­tle less than three years ago. There’s no im­me­di­ate word on Bin­iszkiewicz’s next step.

→ Je­re­my Cald­well is trad­ing the CSO seat at Arde­lyx $ARDX for a CEO job at an undis­closed “ear­ly stage biotech start-up com­pa­ny based in San Diego,” the Fre­mont, CA-based com­pa­ny an­nounced to­day. His de­par­ture from the biotech, best known for IBS drug tena­panor, fol­lows a bumpy three-year ride that set tena­panor on course for an NDA sub­mis­sion de­spite some doubts along the way. No suc­ces­sor has been named just yet. “I be­lieve that tena­panor will play a crit­i­cal role in treat­ing both hy­per­phos­phatemia and IBS-C in the fu­ture. I’m proud of what we’ve dis­cov­ered with the RDX013 pro­gram, as it rep­re­sents an en­tire­ly new ap­proach to treat­ing hy­per­kalemia,” Cald­well said in a state­ment.

Uro­Gen Phar­ma $URGN is try­ing out a dif­fer­ent man­age­ment style with the ap­point­ment of Stephen Mul­len­nix — a vet­er­an ex­ec in the en­er­gy in­dus­try — as chief op­er­at­ing of­fi­cer. Mul­len­nix is tasked with build­ing a com­mer­cial en­ter­prise for the uro-on­col­o­gy fo­cused biotech, which has a PhI­II and a cou­ple of PhII pro­grams planned for the year.

→ As Swe­den’s So­bi looks to grow its pres­ence in North Amer­i­ca, it has brought on Lin­ea As­pe­si as VP of hu­man re­sources in the re­gion. As­pe­si will be ex­er­cis­ing the mus­cles she’s built up over the past 20 years — most re­cent­ly at Sanofi — to de­vise strate­gies for ac­quir­ing, man­ag­ing and re­tain­ing tal­ent at the rare dis­ease com­pa­ny.

→ Hav­ing served as chief busi­ness of­fi­cer at Aptinyx — and led fi­nanc­ing rounds to­tal­ing up­wards of $135 mil­lion — since the com­pa­ny was spun out in 2015, Ashish Khan­na is adding the ti­tle of CFO to his busi­ness card. Be­fore that, he was a VP of cor­po­rate de­vel­op­ment at Nau­rex, where he played a part in the $560 mil­lion Al­ler­gan ac­qui­si­tion that re­sult­ed in the cre­ation of NM­DA-tar­get­ing Aptinyx. His new role overs over­sight of all fi­nance and ac­count­ing in ad­di­tion to busi­ness de­vel­op­ment for the Evanston, IL biotech.

→ A month af­ter ex­pe­ri­enc­ing one of the most hu­mil­i­at­ing set­backs in biotech, David Hung is bow­ing out as CEO of Ax­o­vant $AX­ON. Hung, you’ll re­call, had on­ly re­cent­ly com­plet­ed a $14 bil­lion deal to sell Medi­va­tion to Pfiz­er when he agreed to take the helm at Vivek Ra­maswamy’s Alzheimer’s com­pa­ny just 10 months ago. Their 5HT6 drug, once tout­ed with great hope, failed to make a mark on symp­toms of the dis­ease, be­fore an am­a­teur­ish sta­tis­ti­cal er­ror dealt an­oth­er blow to the com­pa­ny’s im­age. Along with Hung went his whole camp: “(d)irec­tors Kate Fal­berg, Tony Ver­non, and Patrick Macha­do have re­signed as mem­bers of the com­pa­ny’s board of di­rec­tors.” Ex-McK­in­sey con­sul­tant and Har­vard Med grad­u­ate Pa­van Cheru­vu is tak­ing Hung’s place. George Bick­er­staff, the for­mer CFO of No­var­tis Phar­ma, joined Ax­o­vant’s board of di­rec­tors along with ex-Unit­ed Ther­a­peu­tics CEO Roger Jeffs.

Sang­amo Ther­a­peu­tics, the long­time gene edit­ing play­er that scored the field’s first hu­man ex­per­i­ment, has hired Heather Turn­er to over­see all le­gal mat­ters as the com­pa­ny ad­vances its zinc fin­ger nu­cle­ase tech. Pre­vi­ous­ly at Atara Bio­ther­a­peu­tics and Orex­i­gen Ther­a­peu­tics, the SVP and gen­er­al coun­sel will ad­vise Sang­amo $SG­MO through late-stage de­vel­op­ment and com­mer­cial­iza­tion.

→ As Hous­ton-based Im­munoMet con­tin­ues to fill its C-suite, it has re­cruit­ed Big Phar­ma vet Vin­cent O’Neill as CMO ex-Syn­dax ex­ec Al­lan Shaw as CFO. Af­ter work­ing on sev­er­al big on­col­o­gy projects at Genen­tech and Glax­o­SmithK­line, O’Neill made a jump to can­cer biotech Mir­na Ther­a­peu­tics, de­sign­ing and man­ag­ing a Phase I clin­i­cal tri­al of its lead prod­uct. That’s the ex­act same phase that Im­munoMet’s lead prod­uct, IM156, is in. Shaw’s ex­per­tise lies more in fi­nance than life sci­ences, and the com­pa­ny — a spin­out of Ko­re­an bio­phar­ma HanAll — hopes that will help them in fundrais­ing.

Kei­th Nazareth is re­tir­ing from phar­ma/nu­traceu­ti­cal man­u­fac­tur­ing com­pa­ny ACG, fol­low­ing a 27-year ca­reer that cul­mi­nat­ed in the VP of Eu­rope po­si­tion. His suc­ces­sor is Steven Fac­er, a vet­er­an of the CRO in­dus­try.

→ Just a day be­fore Ar­bu­tus put the word out about its ex­clu­sive talks with backer Roivant Sci­ences, it an­nounced that CFO and EVP Bruce Cousins is leav­ing the com­pa­ny. Ko­ert Van­de­nEn­den, cur­rent­ly VP of fi­nance, will take over his re­spon­si­bil­i­ties in the in­ter­im.

→ Eye­ing reg­u­la­to­ry fil­ings for three pro­grams over the next two years, blue­bird bio $BLUE has pro­mot­ed Al­i­son Fin­ger as chief com­mer­cial of­fi­cer. Fin­ger joined the CAR-T star as SVP of mar­ket­ing and prod­uct launch in 2015, af­ter two decades launch­ing prod­ucts at Bris­tol-My­ers Squibb. Her new man­date cov­ers com­mer­cial strat­e­gy and ac­cess man­age­ment — which in­cludes the hot is­sues of pric­ing and re­im­burse­ment.

→ For­mer FDA Com­mis­sion­er Robert Califf is join­ing yet an­oth­er San Fran­cis­co com­pa­ny’s board. Less than a year af­ter ac­cept­ing a board seat at Al­pha­bet’s Ver­i­ly, Califf is of­fer­ing his guid­ance to Cy­to­ki­net­ics $CYTK — a com­pa­ny whose ALS fail­ure made our list of biggest pipeline flops last year. Califf is a tenured pro­fes­sor of car­di­ol­o­gy at Duke and has led sev­er­al clin­i­cal car­di­ol­o­gy re­search stud­ies over the course of his ca­reer. That ex­pe­ri­ence will come in handy as Cy­to­ki­net­ics fo­cus­es its at­ten­tion on its heart fail­ure drug can­di­date ome­cam­tiv mer­car­bil — a drug that ac­ti­vates car­diac myosin, amp­ing up the heart’s abil­i­ty to con­tract.

Igny­ta’s CFO Ja­cob Chacko has joined the board at neu­ro­tax­in play­er Bon­ti, where long­time di­rec­tor David Ram­say’s tran­si­tion to CFO like­ly left an open­ing for some­one with fi­nan­cial ex­per­tise.

No­var­tis vet Rick Pan­icuc­ci has joined the board of Q Bio­med, sup­port­ing the prod­uct de­vel­op­ment busi­ness with the ex­pe­ri­ence he’s gained as VP of phar­ma­ceu­ti­cal de­vel­op­ment of a WuXi AppTec sub­sidiary.

→ Fol­low­ing Geno­cea’s $55 mil­lion pub­lic of­fer­ing led by New En­ter­prise As­so­ci­ates, NEA part­ner Ali Be­hba­hani will join the board of the can­cer vac­cine de­vel­op­er $GN­CA.

Aim­mune Ther­a­peu­tics $AIMT, the biotech be­ing watched for its peanut al­ler­gy drug, has re­cruit­ed two more al­ler­gy ex­perts to his sci­en­tif­ic ad­vi­so­ry board: George du Toit of King’s Col­lege Lon­don and Wayne Shref­fler, who splits his time be­tween Mass­a­chu­setts Gen­er­al Hos­pi­tal and Har­vard Med­ical School.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.