Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

Bain Cap­i­tal is de­ploy­ing one of its top in­vestors to Cerev­el Ther­a­peu­tics, steer­ing a $350 mil­lion-plus neu­ro play carved out of Pfiz­er. Or­ly Mis­han — a co-founder and prin­ci­pal of Bain’s life sci­ences unit — was in­volved in the part­ner­ship that birthed the biotech spin­out in the first place. As Cerev­el’s first chief busi­ness of­fi­cer, she is tasked with cor­po­rate de­vel­op­ment, pro­gram man­age­ment as well as tech­ni­cal op­er­a­tions. 

Cerev­el launched last Oc­to­ber af­ter Adam Kop­pel and Chris Gor­don at Bain spear­head­ed a deal to spin the neu­ro­sciences pro­grams Pfiz­er had aban­doned (along­side 300 staffers) out to a new, well-fund­ed com­pa­ny. Since then it’s been build­ing out its own team, fill­ing the lead­er­ship ranks with alum­ni of Sang­amo, Ot­su­ka and Mer­ck.

 “Cerev­el Ther­a­peu­tics is pur­pose-built to progress neu­ro­science ther­a­pies in a sus­tain­able way, and I look for­ward to work­ing with the team to ad­vance the sci­ence in­ter­nal­ly and through ex­ter­nal col­lab­o­ra­tions,” she said in a state­ment. Be­fore join­ing Bain, Mis­han spent more than a decade at the front­line of health­care busi­ness at Boston Sci­en­tif­ic and Bio­gen.

→ In the wake of Sil­la­Jen’s dev­as­tat­ing Phase III ter­mi­na­tion, chief busi­ness of­fi­cer He­le­na Chaye is jump­ing to an­oth­er on­colyt­ic virus com­pa­ny. She is now the CEO of West­ern On­colyt­ics, a Pitts­burgh biotech count­ing on the West­ern Re­serve strain of the vac­cinia virus to de­liv­er mul­ti­ple ways of trig­ger­ing an im­mune re­sponse. In the new job, she re­joins Stephen Thorne, co-founder and CSO, who al­so helped cre­ate Jen­nerex — the Sil­la­Jen pre­de­ces­sor where Chaye was an ear­ly ex­ec­u­tive. 

→ While their lead adeno­sine A2A re­cep­tor an­tag­o­nist pro­gram, EOS100850, is cur­rent­ly in a Phase I/Ib study, Gos­selies, Bel­gium and Cam­bridge, Mass­a­chu­setts-based iTeos Ther­a­peu­tics has an­nounced the ap­point­ment of Matthew Call as COO. Call served in the same role at En­do­cyte — ac­quired last year for $2.1 bil­lion by No­var­tis — where he was re­spon­si­ble for all busi­ness de­vel­op­ment and strate­gic trans­ac­tions. iTeos hopes that their sec­ond pro­gram, a ful­ly hu­man AD­CC-en­abling an­ti-TIG­IT an­ti­body (EOS884448), will en­ter the clin­ic in the sec­ond half of 2019. 

→ As it preps for a com­mer­cial piv­ot, Cir­cas­sia has wooed Pfiz­er vet Jonathan Emms to the new­ly cre­at­ed role of COO and nam­ing him a di­rec­tor while R&D chief Rod Hafn­er steps down from the board. Emms’ ex­pe­ri­ence lead­ing glob­al com­mer­cial ac­tiv­i­ties for Pfiz­er, as well as a stint with GSK, makes him well-po­si­tioned to over­see the British drug­mak­ers’ up­com­ing moves. Chief of all will be the US launch of Du­ak­lir, the COPD drug from As­traZeneca; there are al­so plans to es­tab­lish a new sales team in Chi­na and grow Cir­cas­sia’s pres­ence in Eu­rope. Mean­while, Hafn­er will shift his fo­cus to busi­ness de­vel­op­ment, sup­ply chain, med­ical af­fairs, reg­u­la­to­ry and qual­i­ty mat­ters.

→ Rare dis­ease play­er Strong­bridge Bio­phar­ma has reshuf­fled its C-suite, tap­ping Richard Kol­len­der as COO and pro­mot­ing CBO Robert Lutz to CFO. Kol­len­der, a long­time health­care in­vestor, was a board di­rec­tor. Lutz, a Shire vet, re­places Bri­an Davis as he heads off to oth­er op­por­tu­ni­ties.

Kath­leen Ford Ku­ra

→ Just a year af­ter re­cruit­ing Cel­gene/Re­cep­tos ex­ec John Far­nam to be COO, Ku­ra On­col­o­gy is bring­ing in Kath­leen Ford to fill his shoes. Ford al­so brings im­pres­sive phar­ma cre­den­tials, hav­ing most re­cent­ly head­ed glob­al clin­i­cal op­er­a­tions at Mer­ck KGaA’s Serono and pre­vi­ous­ly held sim­i­lar roles at Mil­len­ni­um and Alk­er­mes. Ku­ra sit­u­ates it­self in the nascent but pop­u­lar field of pre­ci­sion med­i­cine, tar­get­ing pa­tients with par­tic­u­lar ge­net­ic mu­ta­tions, with one reg­is­tra­tion-di­rect­ed study and more pipeline ex­pan­sion un­der­way.

→ For­mer For­est Labs CFO, Fran­cis (Frank) Perier, Jr, is join­ing Spring­Works Ther­a­peu­tics — which launched in the fall of 2017 with a whop­ping $103 mil­lion round and Pfiz­er $PFE as­sets — in the same ca­pac­i­ty. Pri­or to his role at For­est, Perier served as the vice pres­i­dent of fi­nance and op­er­a­tions plan­ning  – Amer­i­c­as Med­i­cines Group at Bris­tol My­ers Squibb. Pre­vi­ous­ly, he served as an ac­count­ing and au­dit­ing part­ner at De­loitte.

→ Amid an on­go­ing shift of its cen­ter of grav­i­ty to the US, Dai­ichi Sankyo has con­sol­i­dat­ed all hu­man re­sources func­tions and brought in Si­mon King to be the chief peo­ple of­fi­cer. King — who brings high-lev­el ex­pe­ri­ence from Bris­tol-My­ers Squibb and As­traZeneca at­tract­ing and man­ag­ing R&D tal­ent — will re­port di­rect­ly to Ko­ji Ogawa, head of the Japan­ese com­pa­ny’s US di­vi­sion. 

MJ MedTech sub­sidiary, Wuhan Gen­er­al Group $WUHN, is want­i­ng to be­come a ma­jor play­er in the US $166 bil­lion med­ical cannabid­i­ol space, as well as psilo­cy­bin and med­i­c­i­nal mush­room health sec­tor. To help with that, the com­pa­ny has ap­point­ed Hy­der Kho­ja — cannabi­noid & psy­che­del­ic med­i­cine sci­en­tist — as CSO. Pre­vi­ous­ly, Kho­ja was a re­search fac­ul­ty for Vir­ginia-Tech, Uni­ver­si­ty of Wyoming & Texas-Tech Uni­ver­si­ty’s Health Sci­ence Cen­ter. Kho­ja co-found­ed In­Med Phar­ma­ceu­ti­cals and di­rect­ed botan­i­cal drug re­search and de­vel­op­ment for their pre-clin­i­cal stage ther­a­pies in­to ap­pli­ca­tion and helped raise over $90 mil­lion for the ven­ture. 

Bi­olog-id — whose mis­sion is to en­sure safe de­liv­ery of health prod­ucts from donor to pa­tient with the help of their patent­ed smart stor­age kits — has slat­ed Om­ni­cell vet, Troy Hilsen­roth, to head the helm of their com­pa­ny as CEO. Hilsen­roth will be tak­ing over for cur­rent CEO, Pierre Par­ent, who will re­main as the com­pa­ny’s pres­i­dent. Pri­or to hop­ping on board, Hilsen­roth was the gen­er­al man­ag­er of the med­ica­tion ad­her­ence di­vi­sion at Om­ni­cell. 

→ Gear­ing up to­wards fur­ther de­vel­op­ing their on­go­ing piv­otal Phase III clin­i­cal, AGENT study of their drug can­di­date ar­foli­tixorin, Iso­fol Med­ical AB an­nounced the ap­point­ment of Roger Tell as CMO, in ad­di­tion to his cur­rent role as CSO. Cur­rent CMO, Karin Gan­löv will tran­si­tion to a new role of se­nior med­ical di­rec­tor, where she will fo­cus on safe­ty and reg­u­la­to­ry. Tell joined the com­pa­ny af­ter a stint at Aprea Ther­a­peu­tics as vice pres­i­dent of clin­i­cal de­vel­op­ment. Tell has served as an ad­vi­sor and on­col­o­gist at Eli Lil­ly, As­traZeneca and Mer­ck Serono

Car­o­line Dircks has been pro­mot­ed from SVP, R&D op­er­a­tions to COO at Bioa­sis Tech­nolo­gies — a com­pa­ny de­vel­op­ing the xB³ plat­form, tech­nol­o­gy for the de­liv­ery of ther­a­peu­tics across the blood-brain bar­ri­er (BBB) and the treat­ment of cen­tral ner­vous sys­tem (CNS) dis­or­ders. Dircks spent 13 years at Bris­tol My­ers Squibb in re­search and de­vel­op­ment op­er­a­tions — most re­cent­ly serv­ing as head of re­gion­al R&D op­er­a­tions and sched­ule man­age­ment. Pri­or to that, she had an 8-year stint at Vion Phar­ma­ceu­ti­cals.

 → Ape­ri­omics, a com­pa­ny fo­cused on iden­ti­fy­ing in­fec­tions, has added Alexan­der Va­len­cia, the for­mer mol­e­c­u­lar lab­o­ra­to­ry di­rec­tor at Cincin­nati Chil­dren’s Hos­pi­tal Med­ical Cen­ter and PerkinElmer Ge­nomics, to their team as CCO. In his new role, Va­len­cia will over­see clin­i­cal test de­vel­op­ment, val­i­da­tions, reg­u­la­to­ry af­fairs and op­er­a­tions on be­half of the com­pa­ny.

Now at the cen­ter of a storm of con­tro­ver­sy over its de­ci­sion to keep its knowl­edge of ma­nip­u­lat­ed da­ta hid­den from reg­u­la­tors dur­ing an FDA re­view, No­var­tis CEO Vas Narasimhan has found a long­time vet­er­an in the ranks to head the sci­en­tif­ic work un­der­way at AveX­is, as CSO, where the in­ci­dent oc­curred. Page Bouchard is tak­ing the place of the two top sci­en­tists at AveX­is — Bri­an Kas­par and his broth­er Al­lan Kas­par — who “have not been in­volved in any op­er­a­tions at AveX­is since ear­ly May 2019 and are no longer with the com­pa­ny.” There’s no word about why they left, but sev­er­al news re­ports sur­faced soon af­ter the state­ment was re­leased — in­clud­ing one from Meg Tir­rell at CN­BC — quot­ing sources at No­var­tis say­ing that the Kas­pars and sev­er­al oth­er sci­en­tists were ter­mi­nat­ed in con­nec­tion with the da­ta ma­nip­u­la­tion.

→ The slow-mov­ing over­haul of the lead­er­ship and strat­e­gy at GSK is tak­ing a fresh turn, and bring­ing an­oth­er woman to the top ranks of the in­dus­try. Glax­o­Smith

Kline said that US phar­ma­ceu­ti­cals pres­i­dent Jack Bai­ley “has de­cid­ed to step down” at the end of the year. And GSK CEO Em­ma Walm­s­ley has re­cruit­ed Mer­ck KGaA’s Maya Mar­tinez-Davis for the role. She’ll be work­ing with glob­al phar­ma chief Luke Miels, an As­traZeneca vet­er­an wooed to a se­nior spot short­ly af­ter Walm­s­ley made her move to the top at GSK. Cur­rent­ly the head of Latin Amer­i­ca and for­mer chief of glob­al on­col­o­gy at Mer­ck KGaA, Mar­tinez-Davis will fit in well with GSK’s com­mer­cial and R&D strat­e­gy in­volv­ing the de­vel­op­ment of new can­cer drugs. R&D chief Hal Bar­ron has made can­cer re­search a top pri­or­i­ty over the past year.

No­var­tis an­nounced that Fab­rice Chouraqui is step­ping down from his role as US phar­ma pres­i­dent and will be re­placed by Vic­tor Bul­to, who has cham­pi­oned Cosen­tyx in the US. In pick­ing Bul­to for the pro­mo­tion, No­var­tis is go­ing with a proven in-house ex­ec, cur­rent­ly in charge of the US im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy fran­chise. The 14-year No­var­tis ex­ec will be re­port­ing to Marie France Tschudin, who runs the glob­al phar­ma group at the Swiss gi­ant. Tschudin her­self is a re­cent ad­di­tion to the top team at No­var­tis. The for­mer pres­i­dent of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions came in a cou­ple of years ago when No­var­tis ac­quired the com­pa­ny and added ra­dio­phar­ma­ceu­ti­cals to its on­col­o­gy port­fo­lio. Bul­to start­ed as a se­nior brand man­ag­er at No­var­tis in 2005.

 → With the brief stint at Ac­celeron be­hind him, Robert Zeldin has found his next CMO role at Roivant’s new au­toim­mune-fo­cused off­shoot, Im­muno­vant. The ap­point­ment brings Zeldin back to his roots in im­munol­o­gy and lever­ages his more re­cent ex­pe­ri­ence with clin­i­cal de­vel­op­ment to ad­vance IMVT-1401, an an­ti­body that fa­cil­i­tates the degra­da­tion of path­o­gen­ic IgG. Brad­ford Mid­dlekauff, a Medarex alum and biotech vet, is al­so join­ing Pe­te Salz­mann’s team as gen­er­al coun­sel.

An­tho­ny Lem­bo Beth Is­rael Dea­coness

→ Hep B vac­cine mak­er, Dy­navax Tech­nolo­gies, has wel­comed Bain Cap­i­tal Life Sci­ences man­ag­ing di­rec­tor, An­drew Hack to its board of di­rec­tors. Hack pre­vi­ous­ly served as the CFO of Ed­i­tas Med­i­cine

Rit­ter Phar­ma­ceu­ti­cals — who is ex­pect­ing Phase III da­ta on its lead prod­uct can­di­date, RP-G28, for lac­tose in­tol­er­ance in Q4 Rit­ter Phar­ma­ceu­ti­cals — has ap­point­ed An­tho­ny Lem­bo to its med­ical ad­vi­so­ry board. Lem­bo is the di­rec­tor, GI motil­i­ty and func­tion­al bow­el dis­or­der cen­ter at Beth Is­rael Dea­coness Med­ical Cen­ter and is a pro­fes­sor of med­i­cine at Har­vard Med­ical School.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,100+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”