Tariq Kas­sum jumps from Ob­sid­i­an to Cel­sius helm; Quell Ther­a­peu­tics taps Iain McGill as new CEO

Tariq Kas­sum Linkedin

→ Cam­bridge, Mass­a­chu­setts-based Cel­sius Ther­a­peu­tics — which was launched in 2018 and backed by Third Rock Ven­tures and GV — has tapped Tariq Kas­sum to the helm. Kas­sum suc­ceed­ed Alex­is Borisy, who has been in­ter­im CEO and who stay as chair­man of the board of di­rec­tors.

Borisy re­cent­ly made an un­ex­pect­ed ex­it from Third Rock, be­fore their record $770 mil­lion fund for its next wave of in­vest­ments in the life sci­ence field.

Kas­sum was the COO at Ob­sid­i­an Ther­a­peu­tics, fol­low­ing stints at Mil­len­ni­um Phar­ma­ceu­ti­cals and Take­da.

Alex Sapir Re­Vi­ral

Alex Sapir has suc­ceed­ed Ed­dy Lit­tler as CEO of Re­Vi­ral — a stick­ler in the tough res­pi­ra­to­ry syn­cy­tial virus (RSV) field — and been elect­ed to the com­pa­ny’s board of di­rec­tors. Lit­tler will as­sume the po­si­tion of COO in­stead. Pri­or to join­ing Re­Vi­ral, Sapir was CEO and pres­i­dent at Do­va Phar­ma­ceu­ti­cals, help­ing raise $160 mil­lion in an IPO and fol­low-on of­fer­ings. In ad­di­tion, Sapir has had stints at Unit­ed Ther­a­peu­tics and GSK.

Iain McGill Linkedin

Weeks af­ter launch­ing out of Syn­cona’s crib, Quell Ther­a­peu­tics — which is spe­cial­iz­ing in the de­vel­op­ment of en­gi­neered Treg cell ther­a­pies — wel­comes Iain McGill as its CEO. Pri­or to join­ing Quell, McGill served as se­nior vice pres­i­dent in Eu­rope and the rest of the world for Jazz Phar­ma­ceu­ti­cals. Be­fore that, McGill had a stint at EU­SA Phar­ma and he al­so worked in var­i­ous po­si­tions in the field of trans­plan­ta­tion and im­munol­o­gy at Wyeth, No­var­tis and Roche Phar­ma­ceu­ti­cals.

James Ward-Lil­ley, CEO of res­pi­ra­to­ry drug de­vel­op­er Vec­tura Group, is step­ping down from both his po­si­tion and the board. Cur­rent CFO Paul Fry will step in as in­ter­im CEO, in ad­di­tion to his cur­rent re­spon­si­bil­i­ties. A search for a new suc­ces­sor will be­gin im­me­di­ate­ly.  

Jes­si­ca Mar­tins­son Sprint Bio­science

Sprint Bio­science CEO An­ders Åberg is step­ping down from his po­si­tion af­ter 10 years in the role, and cur­rent op­er­a­tional man­ag­er and co-founder Jes­si­ca Mar­tins­son will re­place him as the act­ing CEO. Åberg will re­tain his share­hold­ing and re­main as a se­nior ad­vi­sor to the com­pa­ny.

Louis Kay­i­talire Linkedin

→  Cam­bridge, Eng­land-based F-star has ap­point­ed Big Phar­ma vet Louis Kay­i­talire as its CMO. Kay­i­talire will over­see the de­vel­op­ment of F-star’s lead prod­uct can­di­date FS118 — a LAG-3/PD-L1-tar­get­ing tetrava­lent bis­pe­cif­ic an­ti­body cur­rent­ly in a Phase I clin­i­cal tri­al. He will al­so lead the clin­i­cal strat­e­gy and op­er­a­tions for F-star’s pipeline of bis­pecifics, in­clud­ing FS120 and FS222, which are on track for IND sub­mis­sions this year. Kay­i­talire has over 20 years of ex­pe­ri­ence in on­col­o­gy and im­muno-on­col­o­gy ac­cu­mu­lat­ed over the years at Bris­tol-My­ers Squibb, Cel­gene and Eli Lil­ly.

Thomas Schi­neck­er Roche

→ Swiss gi­ant Roche has un­veiled the new head of its $13 bil­lion di­ag­nos­tics unit — one day af­ter the FDA sanc­tioned the ac­cel­er­at­ed ap­proval of the com­pa­ny’s lat­est an­ti­body-drug con­ju­gate. Thomas Schi­neck­er — who has been with the com­pa­ny since 2003 — is be­ing pro­mot­ed to CEO of Roche Di­ag­nos­tics, and will be­gin his tenure from Au­gust 1, the com­pa­ny said. Schi­neck­er will re­place Roland Diggel­mann, who left his post last Au­gust.

In ad­di­tion, Roche board mem­ber Pe­ter Vos­er — who has been with the com­pa­ny since 2011 — has elect­ed to step down to fo­cus on his role as in­ter­im CEO of ABB. Fur­ther­more, Roche’s head of group com­mu­ni­ca­tions, Stephan Feld­haus, is al­so leav­ing and will be re­placed by Bar­bara Schaedler, who is cur­rent­ly head of pub­lic af­fairs at pri­vate en­er­gy com­pa­ny E.ON SE.

Unum Ther­a­peu­tics has en­list­ed sev­er­al C-suite mem­bers on its on­go­ing quest for a new kind of T cell ther­a­py. Matthew Os­borne, a for­mer VP of cor­po­rate af­fairs, com­mu­ni­ca­tions and in­vestors re­la­tions at Voy­ager Ther­a­peu­tics, is the new CFO. Take­da vet Jes­si­ca Sachs has been pro­mot­ed to CMO, re­plac­ing Michael Vas­con­celles. In ad­di­tion, Mert Ak­tar has been ap­point­ed to the new­ly cre­at­ed role of head of busi­ness and cor­po­rate de­vel­op­ment af­ter 8 years at Shire.

Michael Vas­con­celles has been re­cruit­ed by Flat­iron Health to serve as its CMO. Vas­con­celles just left the same po­si­tion at Unum Ther­a­peu­tics. Vas­con­celles’ pre­vi­ous stints in­clude serv­ing at Take­da/Mil­len­ni­um, Gen­zyme and Sanofi On­col­o­gy. Cur­rent­ly, he is as a clin­i­cal in­struc­tor in med­i­cine at Har­vard Med­ical School and is a prac­tic­ing on­col­o­gist and as­so­ciate physi­cian at the Dana-Far­ber Can­cer In­sti­tute and Brigham & Women’s Hos­pi­tal in Boston.

→ Af­ter a re­cent stint as vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance at Charleston Lab­o­ra­to­ries, Mark Man­nebach is join­ing Eiger Bio­Phar­ma­ceu­ti­cals as its vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs.

Mark Man­nebach Linkedin

“Eiger’s pipeline is now late-stage with planned glob­al reg­u­la­to­ry ac­tiv­i­ties in­clud­ing an NDA and MAA for Prog­e­ria and Progeroid Laminopathies, en­roll­ment of a glob­al Phase III study for Lon­a­farnib in HDV, and End of Phase 2 meet­ings for Pegin­ter­fer­on Lamb­da in HDV and Avex­i­tide in Post-Bariatric Hy­po­glycemia,” said David Cory, pres­i­dent and CEO of Eiger. “Mark’s glob­al reg­u­la­to­ry ex­per­tise and ex­pe­ri­ence will strength­en our lead­er­ship team and ex­e­cu­tion.”

Some of Man­nebach’s pre­vi­ous stints in­clude roles at Sanofi, Pfiz­er, Co­vi­di­en and Mallinck­rodt Phar­ma­ceu­ti­cals.

Zy­la Life Sci­ences re­cruit­ed Jef­frey Wilkins as its CMO and se­nior vice pres­i­dent. Wilkins joins the com­pa­ny from the same po­si­tion at Lyc­era. Pri­or to his time at Lyc­era, Wilkins had stints at Nex­ep­tion Ther­a­peu­tics, Cep­taris Ther­a­peu­tics, Acte­lion and GSK.

Deepi­ka Jalota Linkedin

PMV Phar­ma­ceu­ti­cals — a biotech fo­cused on p53-tar­get­ed small mol­e­cule drugs for can­cer — an­nounced the ap­point­ment of Deepi­ka Jalota as its se­nior vice pres­i­dent and head of reg­u­la­to­ry af­fairs.

Pri­or to join­ing the com­pa­ny, Jalota served as vice pres­i­dent glob­al-reg­u­la­to­ry strat­e­gy head, on­col­o­gy at Bay­er Health­care. Be­fore that, Jalota had stints at Sanofi-Aven­tis, For­est Lab­o­ra­to­ries and Proc­tor and Gam­ble.

Chelsea Place John­son Linkedin

Chelsea Place John­son has joined the ear­ly-stage VC At­las Ven­ture as its se­nior as­so­ciate, fo­cus­ing on new com­pa­ny for­ma­tion across ar­eas of un­met med­ical need. John­son, who most re­cent­ly man­aged busi­ness de­vel­op­ment for Tan­go Ther­a­peu­tics, had pre­vi­ous­ly worked at Third Rock Ven­tures.

→ As Ac­celeron Phar­ma ap­proach­es the fin­ish line with lus­pa­ter­cept, co-founder Tom Ma­ni­atis is re­tir­ing from the board while con­tin­u­ing to ad­vise the com­pa­ny’s de­vel­op­ment of TGF-be­ta su­per­fam­i­ly ther­a­peu­tics. Ma­ni­atis co-found­ed the com­pa­ny in 2003 and has since tak­en up a CEO role at New York Genome Cen­ter, which he al­so helped start.

Do­main Ther­a­peu­tics — a bio­phar­ma­ceu­ti­cal com­pa­ny spe­cial­ized in the dis­cov­ery and de­vel­op­ment of new drug can­di­dates tar­get­ing trans­mem­brane re­cep­tors, in par­tic­u­lar, G pro­tein-cou­pled re­cep­tors (GPCRs) — an­nounced the ap­point­ment of Sylvie Rycke­busch to its board of di­rec­tors.

Rycke­busch was most re­cent­ly the CBO the non­prof­it Es­peR­are Foun­da­tion. In ad­di­tion, her ex­pe­ri­ence spans to roles at Mer­ck Serono and as the founder of Oc­tave Biotech Con­sult­ing.

 

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.