Sunao Man­abe takes top job at Dai­ichi Sankyo in wake of As­traZeneca deal; CAR-T play­er Celyad pro­motes Fil­ip­po Pet­ti to CEO

Sunao Man­abe

→ Bare­ly a day af­ter Dai­ichi Sankyo wrapped a mam­moth col­lab­o­ra­tion deal with As­traZeneca, the Japan­ese phar­ma an­nounced a suc­ces­sion plan for its CEO. George Nakaya­ma, who’s keep­ing his chair­man seat, is pass­ing the reins to Sunao Man­abe, cur­rent­ly pres­i­dent and COO. This marks one of the fi­nal tran­si­tions as Nakaya­ma winds down his decades-long ca­reer run with the com­pa­ny, start­ing at Dai­ichi sub­sidiary Sun­to­ry in 1979. He del­e­gat­ed the pres­i­dent role two years ago.

Celyad, the Bel­gian biotech now mak­ing a low-pro­file run for off-the-shelf CAR-T suc­cess along­side more promi­nent peers like Cel­lec­tis, Servi­er and Al­lo­gene, has pro­mot­ed CFO Fil­ip­po Pet­ti to CEO. He re­places Chris­t­ian Hom­sy, who’s step­ping aside to a non-ex­ec­u­tive, sup­port­ing role af­ter lead­ing the com­pa­ny through a tran­si­tion from stem cell ther­a­py for the heart to im­muno-on­col­o­gy dur­ing his 12-year tenure.

→ Palm Beach Gar­dens, Flori­da-based Xcov­ery has tapped two Big Phar­ma vets for top posts at its on­col­o­gy op­er­a­tion. Li Mao, a long time aca­d­e­m­ic, is tak­ing the helm af­ter a stint as head of the John­son & John­son Chi­na Lung Can­cer Cen­ter. Gio­van­ni Sel­vag­gi, who’s served roles at Glax­o­SmithK­line, No­var­tis and Bris­tol-My­ers Squibb in the past nine years, joins as CMO. To­geth­er, they will steer de­vel­op­ment of en­sar­tinib and vorolanib, Phase III and Phase I/II drugs for ALK-pos­i­tive non-small cell lung can­cer and tho­racic can­cer, re­spec­tive­ly — both in­di­ca­tions that Sel­vag­gi be­came fa­mil­iar with over the course of both his med­ical and in­dus­try ca­reers.

Willem Scheele

→ As Imara gets up to full speed with its mid-stage pro­gram for sick­le cell dis­ease, the biotech has wooed Pfiz­er’s rare dis­ease head to be its per­ma­nent CMO. Hav­ing scored a $63 mil­lion round co-led by Ar­ix and Or­biMed just days ago, the Cam­bridge, MA-based biotech is an­tic­i­pat­ing some da­ta on its ex­per­i­men­tal med IMR-687, a phos­pho­di­esterase-9 in­hibitor, by June. Scheele re­places Shi Yin Foo, an ex­ec of the or­phan drug ac­cel­er­a­tor Cy­dan who was help­ing out on an in­ter­im ba­sis.

Rekha Hem­ra­jani is join­ing Ar­cus Bio­sciences $RCUS as chief op­er­at­ing and fi­nan­cial of­fi­cer, a role that com­bines her ex­pe­ri­ence at FLX Bio and 3-V Bio­sciences. The biotech, led by Ter­ry Rosen’s crew at Flexus, is busy eval­u­at­ing sev­er­al Phase I read­outs for its slate of can­cer drugs: AB928, a dual A2a/A2b re­cep­tor an­tag­o­nist; AB154, an an­ti-TIG­IT an­ti­body, and AB680, a small-mol­e­cule CD73 in­hibitor.

Shree­r­am Arad­hye has fol­lowed his old col­league Bill Hin­shaw out No­var­tis’ doors and in­to Ax­cel­la’s C-suite. As EVP and chief de­vel­op­ment of­fi­cer, Arad­hye will steer the Flag­ship-found­ed biotech’s non-IND clin­i­cal stud­ies fo­cused on re­pro­gram­ming me­tab­o­lism with en­doge­nous meta­bol­ic mod­u­la­tors. Karen Lewis, Bio­gen’s for­mer head of hu­man re­sources, has al­so come on board in a sim­i­lar role.

→ Af­ter work­ing with Abing­worth on a num­ber of co-in­vest­ments (in­clud­ing Wil­son Ther­a­peu­tics and Val­ne­va) as a se­nior part­ner at MVM Part­ners, Bali Mu­ralid­har is join­ing Tim Haines’ promi­nent biotech fund. He will be­come part of a glob­al team spread be­tween Lon­don, Boston and Men­lo Park that iden­ti­fies new in­vest­ment op­por­tu­ni­ties and sup­ports star­tups in the ex­ist­ing port­fo­lio.

Turn­ing Point Ther­a­peu­tics has hired ex­pe­ri­enced health­care com­mu­ni­ca­tor Jim Maz­zo­la to lead cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions as it preps its lead ki­nase in­hibitor for a Phase II tri­al in the sec­ond half of the year.

→ In Abzena’s lat­est ef­fort to beef up its man­age­ment team, the bi­o­log­ics con­tract re­search or­ga­ni­za­tion is ap­point­ing Camp­bell Bunce and Bo Adair to the new po­si­tions of CSO and SVP process and op­er­a­tions. Bunce will keep his oth­er role as the head of Abzena’s Cam­bridge, UK, which he’s filled since 2015. Adair, on the oth­er hand, comes from a reg­u­lar con­sult­ing gig fol­low­ing a re­cent job at Ap­tu­it.

Wind­MIL Ther­a­peu­tics has tapped San­jin Zvonić, a sea­soned ex­ec who most re­cent­ly led Prog­en­i­tor Cell Ther­a­py’s in­te­gra­tion in­to Hi­tachi, to lead its process­es and man­u­fac­tur­ing.   

“At Wind­MIL, we’re al­ways look­ing to the fu­ture of can­cer im­munother­a­py, so San­jin’s abil­i­ty to bridge re­search and man­u­fac­tur­ing makes him an ide­al fit for us as we de­liv­er both the cur­rent gen­er­a­tion of MILs and look to­ward de­vel­op­ing the next gen­er­a­tion,” in­ter­im CEO Don Hay­den said, re­fer­ring to the Bal­ti­more biotech’s mar­row-in­fil­trat­ing lym­pho­cytes tech­nol­o­gy.

→ On the heels of a sec­ond glau­co­ma drug ap­proval, Aerie Phar­ma­ceu­ti­cals $AERI has  re­cruit­ed An­gela Jus­tice (for­mer­ly of Sun Phar­ma) as west­ern re­gion­al di­rec­tor, med­ical sci­ence li­ai­son, and Bri­an Saku­ra­da (for­mer­ly of Intar­cia Ther­a­peu­tics) as di­rec­tor of sci­en­tif­ic mar­ket ac­cess. Con­cur­rent­ly, No­var­tis alum David El­lis is join­ing as di­rec­tor of chem­istry while  Karis­ma Shar­ma has been named VP, hu­man re­sources.

→ Af­ter try­ing out re­search and ear­ly de­vel­op­ment at Roche and No­var­tis, Shao­lian Zhou has re­turned to the CRO world. He is now the SVP and lab di­rec­tor for bio­an­a­lyt­i­cal ser­vices at World­wide Clin­i­cal Tri­als, re­spon­si­ble for the over­all op­er­a­tions of the lab fa­cil­i­ty in Austin.

→ As In­tra-Cel­lu­lar Ther­a­pies plots a turn­around and quick launch for its schiz­o­phre­nia drug lu­mate­per­one, it has ap­point­ed Bris­tol-My­ers Squibb vet John Bar­di to spear­head mar­ket ac­cess, pol­i­cy and gov­ern­ment af­fairs. Bar­di jumps to the New York-based biotech $IT­CI from Ot­su­ka, where he played a sim­i­lar role in bring­ing the an­tipsy­chot­ic Abil­i­fy to mar­ket.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

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

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Bio­gen vet jumps to CSO at Third Rock Treg biotech; Karuna CEO is step­ping down, but this is­n't good­bye

Just a few days into her new job, Ellen Cahir-McFarland’s office is being emptied.

Cahir-McFarland, formerly head of research at Annexon, is the new chief scientific officer of Abata Therapeutics, a preclinical biotech that’s developing regulatory T cell, or Treg, therapies for multiple sclerosis. On Monday, Abata will be moving from its current shared space to its new office in Watertown, MA — hence the emptying, Cahir-McFarland tells Endpoints News from a now bare, white-walled office room.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.