John Kaiser finds next CEO role at Duke spin­out Evecx­ia; Im­muno­core vet Namir Has­san moves to I/O biotech Zel­lu­na

Duke spin­out Evecx­ia has re­cruit­ed bio­phar­ma vet John Kaiser to steer clin­i­cal and busi­ness plans for its 5-hy­drox­ytryp­to­phan slow-re­lease de­pres­sion treat­ment. This will be his third time in a CEO role. Af­ter leav­ing a 28-year sales and mar­ket­ing ca­reer at Eli Lil­ly, Kaiser found­ed and ran a now-de­funct biotech, then had a stint as in­ter­im CEO at Cere­cor, where he had or­ches­trat­ed sev­er­al li­cens­ing deals as chief busi­ness of­fi­cer (Cere­cor is al­so de­vel­op­ing, among oth­er things, a de­pres­sion drug). Evecx­ia is now in the clin­ic with EVX-101, a first-line ad­junc­tive treat­ment for de­pressed pa­tients re­spond­ing in­ad­e­quate­ly to con­ven­tion­al an­ti­de­pres­sants, though it’s un­clear ex­act­ly what stage they are in.

Steven Paul has de­cid­ed to ex­tend a 35-year track record with one last shot at a big de­vel­op­ment pro­gram. He is the new chief ex­ec­u­tive of Karuna, a start­up which wants to show that one of the drugs he once cham­pi­oned at Eli Lil­ly can now be read­ied for prime time as a sig­nif­i­cant new an­ti-psy­chot­ic for schiz­o­phre­nia — and then some. Paul, who’s been serv­ing as chair­man at Karuna, stepped down near the be­gin­ning of the year as CEO of Voy­ager, the gene ther­a­py start­up he co-found­ed.

→ Strug­gling to shed a bad rep for a string of ethics scan­dals capped by the ex­plo­sive ac­cu­sa­tions of sev­er­al US Sen­a­tors that com­pa­ny ex­ecs re­cent­ly mis­rep­re­sent­ed the cozy re­la­tion­ship be­tween for­mer CEO Joe Jimenez and Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis is once again look­ing to clean up its act. CEO Vas Narasimhan has re­cruit­ed a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts.

Klaus Moos­may­er will now be charged with keep­ing the com­pa­ny clear of any new ethics scan­dals, which have come fast and fre­quent­ly at the phar­ma gi­ant. The lawyer has spent the past few years as chief com­pli­ance of­fi­cer at Siemens and chairs the An­ti-Cor­rup­tion Task­force of the Busi­ness and In­dus­try Ad­vi­so­ry Com­mit­tee at the Or­ga­ni­za­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment. Moos­may­er is tak­ing the place of Shan­non Thyme Klinger, new­ly pro­mot­ed to group gen­er­al coun­sel in the wake of Fe­lix Ehrat’s abrupt res­ig­na­tion dur­ing the cri­sis that hit No­var­tis as it strug­gled with rev­e­la­tions about their $1.2 mil­lion in pay­ments to Co­hen.

→ The ex­o­dus of top ex­ecs out of a high-per­form­ing Gilead is con­tin­u­ing. The biotech not­ed Tues­day night that Chief Med­ical Of­fi­cer An­drew Cheng is leav­ing the com­pa­ny “to pur­sue an­oth­er op­por­tu­ni­ty.” As of now, we don’t know what that oth­er op­por­tu­ni­ty is, but Gilead $GILD has re­cent­ly seen the de­par­ture of chief R&D ex­ec Nor­bert Bischof­berg­er (to a start­up) as well as the an­nounced ex­its of CEO John Mil­li­gan and long­time com­pa­ny ex­ec John Mar­tin, ex­ec­u­tive chair­man.

Cheng plans to stay on to Sep­tem­ber 7 to help with the tran­si­tion, ac­cord­ing to Gilead. Mean­while Gregg Al­ton has been ap­point­ed to the new­ly cre­at­ed po­si­tion of chief pa­tient of­fi­cer while Di­ana Brainard was pro­mot­ed to Se­nior Vice Pres­i­dent, HIV and Emerg­ing Vi­ral In­fec­tions. Cheng joined Gilead 19 years ago to lead the com­pa­ny’s de­vel­op­ment-stage pro­grams in HIV/AIDS. He was named Ex­ec­u­tive Vice Pres­i­dent in 2015 and CMO in March.

→ Af­ter tak­ing off the past 7 months to trav­el the world and spend time with fam­i­ly, for­mer Foun­da­tion Med­i­cine ex­ec Steve Kaf­ka is join­ing the start­up foundry Third Rock Ven­ture as their lat­est ven­ture part­ner. Kaf­ka has spent the bulk of his ca­reer in fi­nance and op­er­a­tions at var­i­ous bio­phar­ma out­fits, most re­cent­ly serv­ing as pres­i­dent and COO of Foun­da­tion. This will be Kaf­ka’s first post in the VC world, but that’s not un­usu­al for Third Rock part­ners, which prides it­self on op­er­at­ing like a “start­up stu­dio.” “For me, the ear­ly-stage com­pa­ny build is the best part,” Kaf­ka told us. “To be able to go do that again — and again and again — sounds so in­cred­i­bly fun and im­pact­ful to me.”

Al­ler­gan $AGN has re­cruit­ed top can­cer ex­ec­u­tive Charles Hugh-Jones, the guy who’s been lead­ing Pfiz­er On­col­o­gy as CMO, to serve as the phar­ma gi­ant’s new se­nior vice pres­i­dent and chief med­ical of­fi­cer. The move comes just 16 months af­ter Hugh-Jones joined Pfiz­er’s on­col­o­gy arm. Be­fore that, he was a long timer at Sanofi in New Jer­sey, where he held sev­er­al ex­ec­u­tive roles, end­ing up at chief med­ical of­fi­cer in North Amer­i­ca. The move to Al­ler­gan will take Hugh-Jones back to New Jer­sey, as the new gig is at Al­ler­gan’s US head­quar­ters in Madi­son. There, he’ll be re­port­ing to ex­ec­u­tive vice pres­i­dent and chief R&D of­fi­cer David Nichol­son.

→ Af­ter walk­ing away from a long ca­reer in Big Phar­ma last year — on­ly to bail from his start­up of choice on­ly 10 months lat­er — ex-Pfiz­er ex­ec Geno Ger­mano is back on the move. The re­spect­ed bio­phar­ma chief has joined New York-based Elu­ci­da On­col­o­gy, a tiny Cor­nell spin­out work­ing on some fas­ci­nat­ing nanopar­ti­cle tech with ap­pli­ca­tions in can­cer. At Elu­ci­da, Ger­mano will serve as pres­i­dent and CEO — the first full-time post he’s tak­en up since his ab­bre­vi­at­ed stint at In­trex­on, the flashy syn­thet­ic bio start­up he ex­it­ed from last No­vem­ber.

At Pfiz­er, he cul­ti­vat­ed a $14 bil­lion op­er­a­tion and over­saw a port­fo­lio of drugs span­ning sev­er­al ther­a­peu­tics ar­eas. He al­so worked at the top of Pfiz­er’s on­col­o­gy and spe­cial­ty care busi­ness units and di­rect­ed the in­te­gra­tion of in­dus­try gi­ant Wyeth af­ter the mas­sive $68 bil­lion ac­qui­si­tion.

→ As Sig­ilon CEO Paul Wot­ton leaves the post to han­dle a fam­i­ly health is­sue, the com­pa­ny is putting Roge­rio Vi­val­di — a for­mer se­nior ex­ec at Biover­a­tiv ahead of the Sanofi buy­out ear­li­er this year — in his place at the helm. It will be Vi­val­di’s job now to get the start­up in the clin­ic, look­ing to move the up­start’s stem cell ther­a­py pipeline be­yond its ini­tial for­ays in­to di­a­betes, he­mo­phil­ia and lyso­so­mal stor­age dis­or­ders. An en­docri­nol­o­gist by train­ing, Vi­val­di had been ex­ec­u­tive vice pres­i­dent, chief glob­al ther­a­peu­tic op­er­a­tions of­fi­cer at Biover­a­tiv. Vi­val­di al­so co-found­ed and helmed Min­er­va Ther­a­peu­tics.

→ Af­ter ris­ing up the ranks at British T cell re­cep­tor biotech Im­muno­core, Namir Has­san is mov­ing to Nor­way for his next gig in TCR. As chief sci­en­tif­ic of­fi­cer of Oslo-based Zel­lu­na Im­munother­a­py, Has­san is re­spon­si­ble for both man­ag­ing the ex­ist­ing port­fo­lio and lead­ing ef­forts to ex­pand it, all the while build­ing out the re­search team and fa­cil­i­ties. Im­muno­core, a biotech uni­corn not­ed for scor­ing a stun­ning $320 mil­lion Se­ries A, had seen the de­par­tures of CEO Eliot Forster and CFO Paul Fry in the past few months.

→ Now that Pfenex $PFNX looks set to file an NDA for its For­teo me-too, chief med­ical and sci­en­tif­ic of­fi­cer Hu­bert Chen is turn­ing in his no­tice. The San Diego-based com­pa­ny said that while they are search­ing for a suc­ces­sor, his de­par­ture will not af­fect the tra­jec­to­ry of PF708 as they be­lieve their lead as­set al­ready has the FDA’s bless­ing. Be­sides, he will re­main as an ad­vi­sor, sup­port­ing Pfenex’s reg­u­la­to­ry in­ter­ac­tions. Be­sides PF708, Jazz-part­nered Pfenex is de­vel­op­ing a hodge­podge of “ther­a­peu­tic equiv­a­lents,” biosim­i­lars and vac­cines.

Al­lo­gene Ther­a­peu­tics has en­list­ed an­oth­er es­teemed bio­phar­ma ex­ec in its am­bi­tious plan to bring the first al­lo­gene­ic CAR-T can­cer ther­a­pies to mar­ket. Named chief de­vel­op­ment of­fi­cer, Susie Jun is tasked with ac­cel­er­at­ing clin­i­cal de­vel­op­ment of Al­lo­gene’s pre­clin­i­cal as­sets by lever­ag­ing her ex­pe­ri­ence in trans­la­tion­al re­search. Well versed in hema­tol­ogy and on­col­o­gy, Jun had di­rect­ed clin­i­cal re­search at Am­gen and Gilead be­fore land­ing at her most re­cent role in Ab­b­Vie-Stem­cen­trx.

→ Hav­ing seen through Ar­mo Bio­sciences’ promis­ing im­muno-on­col­o­gy drug all the way to an ac­qui­si­tion by Eli Lil­ly, Joseph Lev­eque has found his next stop at Syn­thorx. While his deep I/O ex­per­tise — honed dur­ing stints at Bris­tol-My­ers Squibb and Mer­ck KGaA where he took a front-row seat in the de­vel­op­ment of Op­di­vo, Yer­voy and Baven­cio — made him a stand­out for the job, the new CMO will al­so be re­spon­si­ble for dri­ving the au­toim­mune ap­pli­ca­tions of Syn­thorx’s par­tial­ly syn­thet­ic bi­o­log­ics. The start­up, based in San Diego, builds its tech on a syn­thet­ic DNA base pair en­gi­neered by Scripps pro­fes­sor Floyd Romes­berg that has the po­ten­tial to tweak pro­teins by in­tro­duc­ing nov­el amino acids.

→ Long­time in­vest­ment banker An­tho­ny Gib­ney is jump­ing to the CBO seat at Achillion $ACHN for a change. Hav­ing ob­served the com­pa­ny from the oth­er side of the ta­ble as co-head of the biotech team at Leerink, Gib­ney will now be in­volved in cor­po­rate strat­e­gy, busi­ness de­vel­op­ment, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Bri­an Di­Do­na­to, an­oth­er for­mer banker, has been hired to work un­der Gib­ney.

Car­ol Suh is the lat­est mem­ber of the biotech in­vest­ment team at Arch Ven­ture Part­ners, where she’s worked as a con­sul­tant/in­tern since Feb­ru­ary. Fresh out of Stan­ford’s busi­ness school, the 28-year-old has pre­vi­ous­ly worked on Ma­gen­ta Ther­a­peu­tics’ launch and, be­fore that, served as an in­no­va­tion fel­low at Glax­o­SmithK­line spe­cial­iz­ing in stem cell and re­gen­er­a­tive med­i­cines.

→ We now know where Alan Mus­so is go­ing af­ter Bel­licum. Pelo­ton Ther­a­peu­tics has tapped the sea­soned fundrais­er as its first CFO. The Dal­las-based com­pa­ny, which is de­vel­op­ing what it hopes will be a first-in-class can­cer drug, is al­so count­ing on Mus­so for in­vestor re­la­tions, ac­count­ing, hu­man re­sources, in­for­ma­tion sys­tems, and op­er­a­tions.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”