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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

→ A Big Pharma vet has joined Cambridge, MA upstart Vedanta Biosciences to help develop and expand on its microbiome-derived bacteria portfolio.

Jeffrey Silber signed on as CMO of Vedanta after 4 years at EMD Serono as their SVP, global clinical development. Silber worked his way through the ranks at Merck in the late 1990s, eventually becoming their VP and therapeutic area head, vaccine clinical research. And after 16 years at the pharma giant, Silber moved on to AbbVie to be their VP, strategic portfolio development.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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#ES­MO20: Re­gen­eron, Sanofi eye an­oth­er first for their PD-1 con­tender Lib­tayo with promis­ing da­ta for on­col­o­gy niche

Regeneron and Sanofi took another step forward in the long march towards a greatly expanded market for their late-bloomer PD-1 checkpoint Libtayo.

The two occasional allies posted an objective response rate of 31% for Libtayo among 84 patients suffering from advanced cases of basal cell carcinoma at virtual ESMO. That spotlights progress for 26 patients, 5 of whom had a complete response. The data also reflect a boost in the number of responses seen from the last cut of the numbers.

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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

Pfiz­er ex­ecs con­fi­dent­ly tap their top 10 block­busters-to-be. But what are the chances of sur­viv­ing PhI­II, let alone hit­ting these big peak sales es­ti­mates?

Pfizer’s top executive team doesn’t lack for confidence.

Where many Big Pharmas would be reluctant to put a peak sales figure on their late-stage drugs, Pfizer CEO Albert Bourla has shrugged off the usual diffidence to outline where the pharma giant expects to get $15 billion-plus.

The list, outlined this week during their investor presentations, is topped by 3 drugs in the $3 billion-plus peak sales category. They are:

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Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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Sean Bo­hen's break from bio­phar­ma is over. The ex-As­traZeneca CMO has re­tired his Big Phar­ma jer­sey and is now — hap­pi­ly — run­ning a lit­tle biotech

The last I had heard about Sean Bohen, he had stepped out of his high-profile job as chief medical officer at AstraZeneca at the beginning of 2019 as CEO Pascal Soriot triggered a broad-ranging R&D shakeup. And then, earlier this week, I got a chance to catch up.

It turns out that Bohen decided at the time that he would not just jump into a new job in the booming biopharma business. As an oncologist, he had worked on the big programs at AstraZeneca, and before that he was at Genentech. That was good for a ticket to just about anyplace in the big biopharma world. But he felt it was time to stop and think things through.

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