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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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