Amy Bur­roughs to lead Cleave Ther­a­peu­tics; Cyn­thia Collins clinch­es Ed­i­tas CEO job amid his­toric CRISPR move

Amy Bur­roughs

→ Af­ter bag­ging $12 mil­lion to ad­vance its lead drug can­di­date CB-5339 — a (VCP)/p97 in­hibitor — through ear­ly clin­i­cal de­vel­op­ment, Cleave Ther­a­peu­tics is beef­ing up its ex­ec­u­tive team. Amy Bur­roughs will be lead­ing the helm as CEO while Scott Har­ris joins as COO. Bur­roughs was an ex­ec­u­tive-in-res­i­dence at 5AM Ven­tures, which led the re­cent fi­nanc­ing, where she al­so served as a strate­gic com­mer­cial ad­vi­sor to port­fo­lio com­pa­ny Cri­net­ics Phar­ma­ceu­ti­cals. Giv­en her ear­ly ex­pe­ri­ence with the team at Genen­tech and back­ground in life sci­ences con­sult­ing, Bur­roughs brings crit­i­cal per­spec­tives on “un­der­stand­ing mar­ket needs, build­ing part­ner­ships and at­tract­ing top-notch tal­ent,” said board chair­man and for­mer Cleave CEO Lau­ra Shawver.

Har­ris most re­cent­ly served at two Bridge­Bio sub­sidiaries, in­clud­ing as ex­ec­u­tive vice pres­i­dent, cor­po­rate de­vel­op­ment and op­er­a­tions at Navire Phar­ma. He’s had a stint as ex­ec­u­tive vice pres­i­dent of reg­u­la­to­ry af­fairs and tech­ni­cal op­er­a­tions at Ad­ynxx and honed his cross-func­tion­al acu­men across Corthera, Bio­Marin Phar­ma­ceu­ti­cal, At­ten­uon, Angstrom Phar­ma­ceu­ti­cal and Biosite.

Cyn­thia Collins

Sev­en months af­ter Ka­trine Bosley abrupt­ly stepped down from Ed­i­tas, Cyn­thia Collins has been con­firmed as the of­fi­cial pres­i­dent and CEO. Collins — a board mem­ber and for­mer CEO of Hu­man Longevi­ty — has presided over the re­cent ini­ti­a­tion of Ed­i­tas’ first hu­man tri­al, and will now con­tin­ue to steer the biotech along the his­toric CRISPR move. The dos­ing of ED­IT-101 (or AGN-151587, as their part­ners at Al­ler­gan, call it) would mark the first test of in vi­vo edit­ing us­ing CRISPR/Cas9 — more specif­i­cal­ly, to a ge­net­ic mu­ta­tion that caus­es a rare form of blind­ness known as Leber con­gen­i­tal amau­ro­sis 10 (LCA10). She will al­so work on “mov­ing clos­er to the clin­ic with ED­IT-301 for the treat­ment of sick­le cell dis­ease, ex­pand­ing our port­fo­lio through strate­gic busi­ness de­vel­op­ment, and build­ing our or­ga­ni­za­tion­al ca­pa­bil­i­ties to scale for growth,” Collins added in a state­ment.

Jay Shep­ard

Ar­a­vive CEO and pres­i­dent Jay Shep­ard will be step­ping down from his roles in the com­pa­ny “for fam­i­ly med­ical rea­sons.” The com­pa­ny’s board of di­rec­tors is com­menc­ing a search for his suc­ces­sor, and in the mean­time, Shep­ard plans to serve in his cur­rent role un­til a suc­ces­sor is ap­point­ed. Shep­ard’s de­par­ture comes as the com­pa­ny has ini­ti­at­ed the Phase 1b por­tion of a Phase 1b/2 clin­i­cal tri­al for their lead drug can­di­date, AVB-500 — an affin­i­ty de­coy pro­tein that tar­gets the GAS6-AXL sig­nal­ing path­way — com­bined with stan­dard of care ther­a­pies in pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. 

→ A Phase III ready Pal­la­dio Bio­sciences — with a lead drug, lix­i­vap­tan, lined up for poly­cys­tic kid­ney dis­ease — has picked Alex Mar­tin to lead their com­pa­ny as CEO. Mar­tin had the top job at Realm Ther­a­peu­tics be­fore its ac­qui­si­tion by ES­SA Phar­ma in Ju­ly and has held the COO role at In­ter­cept Phar­ma­ceu­ti­cals. He be­gan his ca­reer at SmithK­line Beecham and lat­er be­came vice pres­i­dent, busi­ness de­vel­op­ment & li­cens­ing at No­var­tis, grad­u­al­ly build­ing a fo­cus on BD, op­er­a­tions and fundrais­ing.

Mer­ck and Il­lu­mi­na-backed Ser­im­mune has brought on Noah Nass­er to over­see the com­mer­cial­iza­tion of its “im­mune in­tel­li­gence” tech­nol­o­gy plat­form map­ping the range of anti­gens stim­u­lat­ing im­mu­ni­ty. The new CEO, who hops over from the chief com­mer­cial of­fi­cer po­si­tion at Hu­man Longevity, sees “re­mark­able op­por­tu­ni­ties” in in­fec­tious dis­ease, on­col­o­gy and au­toim­mune dis­ease. Nass­er has led sim­i­lar func­tions at mul­ti­ple ge­net­ic test­ing com­pa­nies, in­clud­ing ones that were ul­ti­mate­ly ac­quired by Myr­i­ad Ge­net­ics and Il­lu­mi­na. Ser­im­mune’s founder, Patrick Daugh­er­ty, will con­tin­ue to act as the com­pa­ny’s CSO and board mem­ber. Il­lu­mi­na Ven­tures part­ner Bill Welch is join­ing the board of di­rec­tors.

Sud­ha Para­sur­a­man

Ri­bon Ther­a­peu­tics, the biotech backed by No­var­tis, Cel­gene and J&J to go af­ter new class­es of en­zyme fam­i­lies ac­ti­vat­ed un­der cel­lu­lar stress con­di­tions, has named Sud­ha Para­sur­a­man and Ed­ward “Tad” Stew­art its first-ever CMO and CBO, re­spec­tive­ly. Well versed in hema­tol­ogy, on­col­o­gy and pe­di­atrics, Para­sur­a­man held the same role at X4 Phar­ma­ceu­ti­cals and pri­or to that was VP, glob­al med­ical af­fairs at he­mo­phil­ia play­er uniQure. Her ca­reer has al­so tak­en her to No­var­tis and Mil­len­ni­um Phar­ma­ceu­ti­cals (now Take­da On­col­o­gy), as well as Har­vard Med­ical School, Chil­dren’s Hos­pi­tal of Boston, and Dana Far­ber Can­cer In­sti­tute. Stew­art, who spent over 15 years at Mer­ri­mack Phar­ma­ceu­ti­cals, was the pres­i­dent and CEO of Com­mense and CBO of Crescen­do

Bams Abi­la

Im­mod­u­lon — a UK biotech de­vel­op­ing im­mune-mod­u­lat­ing bac­te­r­i­al add-on can­cer ther­a­pies to check­point and chemo —  has se­lect­ed phar­ma vet Bams Abi­la as their CMO. Most re­cent­ly, Abi­la served as the CMO of Cmed and as the prin­ci­pal con­sul­tant at Clin­treq. His pre­vi­ous ex­pe­ri­ences in­clude lead­er­ship roles at Aven­tis, Pfiz­er, Astel­las, As­traZeneca and GSK. Abi­la was ap­point­ed as a vis­it­ing pro­fes­sor of bi­o­log­ics and ad­vanced ther­a­py drug de­vel­op­ment to the Fac­ul­ty of Life Sci­ences & Med­i­cine at King’s Col­lege Lon­don in 2015. He is a fel­low of the Fac­ul­ty of Phar­ma­ceu­ti­cal Med­i­cine of the Roy­al Col­lege of Physi­cians in the UK. 

→ The ma­chine learn­ing-dri­ven drug dis­cov­ery spe­cial­ists at Daphne Koller’s start­up in­sitro have wel­comed Mary Rozen­man to their ranks as CFO/CBO while tap­ping Kei­th James as SVP drug dis­cov­ery. Their ap­point­ments high­light the com­pa­ny’s com­mit­ment to not just iden­ti­fy nov­el tar­gets but to achieve its re­al goal of de­vel­op­ing nov­el, bet­ter ther­a­peu­tics faster while en­vi­sion­ing new types of col­lab­o­ra­tions. Rozen­man was the SVP of cor­po­rate de­vel­op­ment at Aim­mune Ther­a­peu­tics; be­fore that she learned the ins and outs of biotech in­vest­ments and fi­nanc­ing as a VP at Lon­gi­tude Cap­i­tal and a ju­nior part­ner at McK­in­sey & Com­pa­ny. James, a Pfiz­er vet with mul­ti­ple clin­i­cal can­di­dates to his name, was the pres­i­dent of the Fer­ring Re­search In­sti­tute and a vis­it­ing in­ves­ti­ga­tor at The Scripps Re­search In­sti­tute

→ With its lead prod­uct can­di­date for re­frac­to­ry angi­na now in the clin­ic, Xy­lo­Cor Ther­a­peu­tics has re­cruit­ed Rick­ey Rein­hardt as their CMO. Hav­ing led the Eu­ro­pean ap­proval for GSK’s Strimvel­lis and di­rect­ed clin­i­cal R&D at Re­genxbio, Rein­hardt will now ap­ply his ex­per­tise in gene ther­a­py to the car­dio­vas­cu­lar niche. Most re­cent­ly he was CMO at Comet Ther­a­peu­tics, where he chan­neled his deep ex­pe­ri­ence in me­tab­o­lism.

Ajim Tam­boli Rodin

→ Synap­tic-fo­cused biotech Rodin Ther­a­peu­tics has ap­point­ed Ajim Tam­boli as CFO. A long­time health­care in­vestor, Tam­boli comes on board af­ter a stint at Asym­me­try Cap­i­tal Man­age­ment. He was an an­a­lyst at Lehman Broth­ers, Cred­it Su­isse and Lazard Fr­eres, with a num­ber of IPOs and fol­low-on of­fer­ings un­der his belt, be­fore found­ing En­durant Cap­i­tal Man­age­ment.

→ Just a few weeks af­ter tak­ing his $1.1 mil­lion sev­er­ance check from Gilead, John McHutchi­son has re-emerged as the new CEO of As­sem­bly Bio­sciences, which has seen its share price swoon as in­vestors lost con­fi­dence in its abil­i­ty to com­pete with Gilead with its ex­per­i­men­tal he­pati­tis B drug. McHutchi­son will be join­ing Steven J. Knox in the new job. Knox left as head of clin­i­cal de­vel­op­ment at Gilead, where he al­so played a big role in the de­vel­op­ment of the hep B drug Vem­lidy, to join As­sem­bly in the same role. 

Josh Bilenker didn’t just gain a per­son­al wind­fall by sell­ing Loxo to Eli Lil­ly for $8.1 bil­lion. He got a new, if tem­po­rary, job out of the deal as well. Bilenker will now head on­col­o­gy re­search and ear­ly phase de­vel­op­ment as they look for a re­place­ment for Levi Gar­raway, now head­ed off in pur­suit of “oth­er op­por­tu­ni­ties.” In ad­di­tion, Long­time BD chief Dar­ren Car­roll is head­ed to re­tire­ment af­ter 22 years at the phar­ma gi­ant. Heather Wasser­man has been pro­mot­ed to vice pres­i­dent of cor­po­rate busi­ness de­vel­op­ment, with re­spon­si­bil­i­ty for busi­ness de­vel­op­ment trans­ac­tions, emerg­ing tech­nolo­gies and in­no­va­tion, and ven­ture cap­i­tal, SVP/trea­sur­er Phil John­son will be in charge of M&A and Frank Cun­ning­ham has been pro­mot­ed to se­nior vice pres­i­dent of man­aged health­care ser­vices.

Teri Lox­am

→ Cell ther­a­py play­er SQZ Biotech has wooed se­nior Mer­ck ex­ec Teri Lox­am to be­come its CFO. The phar­ma gi­ant said that Lox­am, who’s been man­ag­ing in­vestor re­la­tions and glob­al com­mu­ni­ca­tions, “will be missed per­son­al­ly and pro­fes­sion­al­ly.” Pe­ter Dan­nen­baum has been pro­mot­ed to fill her shoes.

Ve­r­avas — a med­ical di­ag­nos­tic com­pa­ny fo­cused on bi­otin — has tapped Car­roll Street­man Jr to head the com­pa­ny as CEO. Dur­ing his 45-year ca­reer in the in­dus­try, Street­man has been in man­age­ment po­si­tions at med­ical ser­vices com­pa­ny Full Spec­trum Be­hav­ior Analy­sis, Di­a­Sorin, CSHC Con­sul­tants and HCA Health­care Cor­po­ra­tion. It was at Di­a­Sorin that he first worked with Ve­r­avas’ CSO, Josh Sol­do.

→ As Or­thofix Med­ical CEO Brad Ma­son steps in­to re­tire­ment, he’s pass­ing the ba­ton to sea­soned med­ical de­vice ex­ec Jon Ser­bousek. Aside from lead­ing the whole mus­cu­loskele­tal op­er­a­tion, Ser­bousek has al­so been named pres­i­dent of the spine unit.

Jon Ser­bousek

Aprea Ther­a­peu­tics, a can­cer biotech with head­quar­ters in both Boston and Stock­holm, has ap­point­ed Scott Coiante as the com­pa­ny’s se­nior vice pres­i­dent and CFO, join­ing from Ag­ile Ther­a­peu­tics where he held the same roles. Pri­or to his time at Ag­ile, Coiante served as the vice pres­i­dent of fi­nance and trea­sur­er at Medarex be­fore its ac­qui­si­tion in 2009 by Bris­tol My­ers Squibb.

Emalex Bio­sciences has en­list­ed At­ul Ma­h­ablesh­warkar on their mis­sion to de­vel­op ecopi­pam for pe­di­atric Tourette Syn­drome and child­hood-on­set flu­en­cy dis­or­der. As SVP of drug de­vel­op­ment, Ma­h­ablesh­warkar is tasked with every­thing from clin­i­cal af­fairs, phar­ma­covig­i­lance, reg­u­la­to­ry mat­ters to qual­i­ty as­sur­ance. The new role will draw on both his train­ing in psy­chi­a­try and years of de­vel­op­ment ex­pe­ri­ence ac­crued at Take­da, Black­Thorn and most re­cent­ly Re­vance.

No­vo Nordisk vet Lars Green is switch­ing ship af­ter 27 years to take charge of fi­nance, IT, le­gal and in­vestors re­la­tions as CFO of Novozyme — the en­zyme shop split off from the No­vo con­glom­er­ate al­most two decades ago. In his last role at the Dan­ish in­sulin mak­er, he head­ed up busi­ness ser­vices and com­pli­ance af­ter a stint lead­ing fi­nance and op­er­a­tions. In con­junc­tion with his ap­point­ment, he’s re­sign­ing from Novozyme’s board, where he’s served as a di­rec­tor since 2014.

Col­in God­dard Hi­ber­Cell

Christoph Rentsch has re­signed from the CFO post at Swiss spe­cial­ty phar­ma San­thera. Rentsch, whose ca­reer has spanned Cred­it Su­isse, Lon­za, Roche and Polyphor, was cred­it­ed for sev­er­al cor­po­rate fi­nance trans­ac­tions at San­thera, which has been on a bumpy ride with its Duchenne mus­cu­lar dy­s­tro­phy drug.

→ Lead­ing can­cer im­munother­a­py pi­o­neer Alan Ko­r­man, who is cred­it­ed for his work at BMS and Medarex that led to the de­vel­op­ment of two of the first ap­proved can­cer im­munother­a­py drugs, ip­il­i­mum­ab (an­ti-CLTA-4) and nivolum­ab (an­ti-PD-1) and their com­bi­na­tion, has joined the sci­en­tif­ic ad­vi­so­ry board of Drag­on­fly Ther­a­peu­tics

Steven Gillis Hi­ber­Cell

→ New York-based Hi­ber­Cell has ap­point­ed ex-OSI Phar­ma CEO Col­in God­dard to the board of di­rec­tors. God­dard will serve un­der new­ly mint­ed chair­man Steven Gillis, a man­ag­ing di­rec­tor at Arch who is prob­a­bly best known as founder of Im­munex.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

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.

Nick Plugis, Avak Kahvejian, Cristina Rondinone, Milind Kamkolkar and Chad Nusbaum. (Cellarity)

Cel­lar­i­ty, Flag­ship's $50M bet on net­work bi­ol­o­gy, mar­ries ma­chine learn­ing and sin­gle-cell tech for drug dis­cov­ery

Cellarity started with a simple — but far from easy — idea that Avak Kahvejian and his team were floating around at Flagship Pioneering: to digitally encode a cell.

As he and his senior associate Nick Plugis dug deeper into the concept, they found that most of the models others have developed take a bottom-up approach, where they assemble the molecules inside cells and the connections between them from scratch. What if they opt for a top-down approach, aided by single-cell transcriptomics and machine learning, to gauge the behavior of the entire cellular network?