Peer Re­view: Anil Sing­hal as­sumes lead­er­ship of Adicet Bio; Adap­tive Biotech woos Genen­tech vet as CMO

→ More than a year af­ter Aya Jakobovits abrupt­ly va­cat­ed the CEO of­fice, Adicet Bio has found her per­ma­nent suc­ces­sor just ahead of its first IND. Anil Sing­hal takes over from Don­ald San­tel, the ex­ec­u­tive chair­man who’s been fill­ing the role. An Ab­b­Vie vet, Sing­hal joins the im­munother­a­py com­pa­ny with some fresh biotech ex­pe­ri­ence as ex­ec­u­tive-in-res­i­dence at Canaan Part­ners and CSO of On­coRe­sponse.

Lance Bal­do

→ At the be­gin­ning of this year, Adap­tive Biotech­nolo­gies scored $300 mil­lion in up­front cash from Roche’s Genen­tech for ac­cess to its T cell re­cep­tor iden­ti­fy­ing plat­form. Four months lat­er, the Seat­tle-based biotech has poached one of its top ex­ecs, too. Lance Bal­do, who had a hand in launch­ing Hem­li­bra and Ocre­vus as Genen­tech’s head of US med­ical af­fairs, is com­ing on board as CMO. Aside from its cell ther­a­py plat­form, Bal­do said he’s al­so drawn to Adap­tive’s po­ten­tial in di­ag­nos­ing and mon­i­tor­ing dis­ease of the im­mune sys­tem.

Rob Ian­none

→ CMO Rob Ian­none an­nounced Mon­day that he’s leav­ing Im­munomedics to move to a new ca­reer in Penn­syl­va­nia so that he can be clos­er to his fam­i­ly. His plans come as the com­pa­ny is suf­fer­ing from set­backs and de­par­tures. CEO Michael Pehl left two months ear­li­er af­ter ac­cu­sa­tions of a da­ta in­tegri­ty breach and when the com­pa­ny’s lead drug — the an­it­body drug con­ju­gate IM­MU-132, or sac­i­tuzum­ab govite­can — was re­ject­ed by the FDA.

→ The Cana­di­an pen­ny stock biotech Tril­li­um Ther­a­peu­tics has an­nounced that CEO Niclas Stiern­holm has abrupt­ly re­signed from the com­pa­ny. As they search for a re­place­ment, Robert Kirk­man, the cur­rent chair­man of the board, will act as ex­ec­u­tive chair­man. CSO Bob Uger will as­sume the role of in­ter­im pres­i­dent.

Robin Wash­ing­ton

→ Ahead of re­leas­ing its first-quar­ter re­sults on Thurs­day, Gilead dis­closed yet an­oth­er se­nior ex­ec­u­tive de­par­ture: long­time CFO Robin Wash­ing­ton, who un­veiled plans to ex­it come March 2020. In par­al­lel with the drug­mak­er’s an­nounce­ment on Tues­day, Google’s par­ent com­pa­ny Al­pha­bet un­veiled Wash­ing­ton was set to serve on its board.

Amy Pott

→ As it looks to ex­pand its US foot­print, Swedish rare dis­ease spe­cial­ist So­bi has wooed Amy Pott from Shire to head up its North Amer­i­can op­er­a­tions. Hav­ing over­seen com­mer­cial op­er­a­tions, strat­e­gy and plan­ning for both Shire and Bax­al­ta, Pott joins So­bi af­ter a pe­ri­od of rapid growth — qua­dru­pling its work­force in two years — over­seen by Ra­mi Levin.

Joanne Smith-Far­rell

Joanne Smith-Far­rell is get­ting pro­mot­ed to chief busi­ness of­fi­cer at blue­bird bio. The Mer­ck vet spent the past two years hus­tling deals and bring­ing in new tools and part­ners for the CAR-T and gene ther­a­py pipeline, blue­bird said, while build­ing a team to sup­port the on­col­o­gy fran­chise. She will con­tin­ue to lead that group while as­sum­ing more re­spon­si­bil­i­ty in cor­po­rate de­vel­op­ment and strat­e­gy.

Tama­ra Sey­mour

→ San Diego-based Im­mu­nic $IMUX has ap­point­ed Tama­ra Sey­mour as in­ter­im CFO, bank­ing on her decades of ex­pe­ri­ence in cor­po­rate fi­nance and biotech fundrais­ing as it moves its im­munol­o­gy drugs along the clin­ic. Most re­cent­ly, Sey­mour has been as­sist­ing life sci­ences com­pa­nies with M&A and oth­er needs on an ad­vi­so­ry ba­sis af­ter mul­ti­ple CFO stints at Sig­nal Ge­net­ics, Hemaque­st Phar­ma­ceu­ti­cals, Favrille and more. Im­mu­nic’s lead com­pound is a Phase II drug for ul­cer­a­tive col­i­tis and re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis.

Vivera Phar­ma­ceu­ti­cals has re­cruit­ed Stephen Mc­Col­gan to its mis­sion of har­ness­ing cannabid­i­ol as a non-ad­dic­tive way to man­age pain. “Over the course of my 30-year ca­reer as a sur­geon, I’ve watched opi­oids cause to­tal and com­plete dev­as­ta­tion in pa­tients who had orig­i­nal­ly sought on­ly pain re­lief,” said the new CMO. Based in New­port Beach, CA, Vivera sells a num­ber of CBD for­mu­la­tions.

Maria Koehler

→ Fol­low­ing a brief stint at Bi­cy­cle Ther­a­peu­tics, Maria Koehler has jumped to an­oth­er on­col­o­gy start­up in the Boston area. Re­pare Ther­a­peu­tics drug dis­cov­ery ef­forts are guid­ed by a com­bi­na­tion of DNA dam­age re­sponse and syn­thet­ic lethal­i­ty, aid­ed by CRISPR screen­ing. Koehler is now tasked with test­ing those com­pounds in the clin­ic. Al­so join­ing the com­pa­ny is CFO Kati­na Dor­ton, who had the same role in Avro­bio.

Kati­na Dor­ton

→ Poised to be­gin a piv­otal study, can­cer drug de­vel­op­er Rainier Ther­a­peu­tics (you might re­mem­ber it as Bio­Clin) has scooped Gary Chris­tian­son from Nohla Ther­a­peu­tics, where he was COO. In his new po­si­tion of chief tech­ni­cal of­fi­cer, Chris­tian­son will over­see man­u­fac­tur­ing of vo­fa­tam­ab, an an­ti-FGFR3 drug for blad­der can­cer. Pri­or to Nohla, Chris­tian­son honed his com­mer­cial prod­uct de­vel­op­ment ex­per­tise at Cas­ca­di­an Ther­a­peu­tics (ac­quired by Seat­tle Ge­net­ics) and Corixa (lat­er Glax­o­SmithK­line).

William Gross­man

→ With a new PD-1 in the pipeline and a bio­mark­er al­liance with Stra­ta On­col­o­gy in place, Ar­cus Bio­sciences has wooed the ex­pe­ri­enced I/O vet William Gross­man as their new CMO from Bel­licum. Gross­man is cred­it­ed with a lead­ing role in 50 clin­i­cal tri­als, with a big hand in the de­vel­op­ment of Tecen­triq at Genen­tech. Gross­man will be step­ping in­to an ac­tive, clin­i­cal-stage on­col­o­gy pro­gram, with an on­go­ing Phase I monother­a­py dose-es­ca­la­tion tri­al in pa­tients with ad­vanced tu­mors and oth­er com­bi­na­tion stud­ies.

→ Hav­ing cut back on its urol­o­gy and CNS ef­forts and de­cid­ed to stay laser fo­cused on de­vel­op­ing its lead drug for sleep dis­or­ders, Avadel Phar­ma­ceu­ti­cals $AVDL has hired neu­ro­log­i­cal ex­pert Jor­dan Dubow as CMO. He is now tasked with re­fin­ing clin­i­cal de­vel­op­ment and reg­u­la­to­ry plans for FT218, a treat­ment Avadel hopes to mar­ket as a more con­ve­nient op­tion for ex­ces­sive day­time sleepi­ness and cat­a­plexy in nar­colep­sy pa­tients. Pri­or to this ap­point­ment, Dubow served in a num­ber of sim­i­lar roles at Es­teve, Clin­trex, Marathon and Ab­b­Vie.

Gra­ham Coop­er

Gra­ham Coop­er is leav­ing As­sem­bly Bio­sciences af­ter one year, leav­ing open the CFO and COO roles passed on by co-founder David Bar­rett. Michael Samar, the cur­rent VP of fi­nance and busi­ness op­er­a­tions, will take on the ac­count­ing and cer­tain oth­er tasks as the hep B biotech $ASMB hunts for a new CFO. Mean­while, Aptinyx alum and bio­phar­ma vet David Houck is join­ing as SVP of prod­uct de­vel­op­ment and port­fo­lio man­age­ment to lead a nascent clin­i­cal ef­fort for both HBV and a few Al­ler­gan-part­nered mi­cro­bio­me pro­grams.

→ Fresh off a $100 mil­lion round, Guo-Liang Yu has added a CMO to the trans-Pa­cif­ic team he’s build­ing for Apol­lomics. Fabio Benedet­ti brings a back­ground in on­col­o­gy port­fo­lio man­age­ment from Tai­ho, Geron, Onyx and Mil­len­ni­um. Be­tween Apol­lomics’ Cal­i­for­nia and Chi­na of­fices, Benedet­ti will over­see a pipeline of can­cer com­bi­na­tion ther­a­pies part­nered with a host of Chi­nese biotechs.

CAN­bridge Phar­ma­ceu­ti­cals has tapped sea­soned health­care banker Glenn Has­san for a dual po­si­tion of CFO and chief busi­ness of­fi­cer. Has­san was most re­cent­ly at Chi­na Re­nais­sance Cap­i­tal but pre­vi­ous­ly held in­vest­ment and an­a­lyst roles at Leerink, Citadel and Fi­deli­ty In­vest­ments. The Chi­nese rare dis­ease play­er has al­so en­list­ed for­mer Ed­i­tas Med­i­cines CMO Ger­ald Cox as chief de­vel­op­ment strate­gist and in­ter­im CMO to tem­porar­i­ly re­place May Or­fali, who re­signed for per­son­al rea­sons.

→ In the mid­dle of an IPO at­tempt, Ap­plied Ther­a­peu­tics has named Mark Vi­g­no­la its CFO, tasked with find­ing friends for the com­pa­ny in the fi­nan­cial com­mu­ni­ty. Vi­g­no­la was head of cor­po­rate de­vel­op­ment and in­vestor re­la­tions at In­ter­cept, his first biotech gig af­ter an eq­ui­ty re­search job at Need­ham & Com­pa­ny. The New York-based biotech is de­vel­op­ing a drug for di­a­bet­ic car­diomy­opa­thy as well as di­a­bet­ic pe­riph­er­al neu­ropa­thy.

→ The genome en­gi­neer­ing ex­perts at In­scrip­ta has brought in an Il­lu­mi­na vet on their jour­ney to pop­u­lar­ize their ver­sion of the CRISPR edit­ing plat­form. Ron Mc­Grath’s ti­tle is CFO, but he will like­ly play a big­ger role in scal­ing the com­pa­ny’s in­fra­struc­ture as it pre­pares to com­mer­cial­ize its prod­uct.

Amy­lyx has ap­point­ed Patrick Yerami­an as CMO and Tom Holmes as glob­al head, sup­ply chain for the com­pa­ny. Both be­gan their re­spec­tive po­si­tions in March 2019. Yerami­an pre­vi­ous­ly held the role of con­sult­ing med­ical di­rec­tor for Amy­lyx and Holmes was the se­nior di­rec­tor of ex­ter­nal man­u­fac­tur­ing at Bio­gen for 10 years.

Zymeworks an­nounced Tues­day that the com­pa­ny is ex­pand­ing its glob­al clin­i­cal de­vel­op­ment team by hir­ing three new vice pres­i­dents. The three in­clude: Mark Hol­ly­wood, se­nior vice pres­i­dent of tech­ni­cal and man­u­fac­tur­ing op­er­a­tions; Neil Joseph­son, vice pres­i­dent of clin­i­cal re­search; and Bruce Hart, vice pres­i­dent of reg­u­la­to­ry af­fairs. David Poon was al­so pro­mot­ed to vice pres­i­dent of busi­ness de­vel­op­ment and al­liance man­age­ment with­in the com­pa­ny.

By Am­ber Tong and Kathy Wong.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. The idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

Tony Kulesa, Brian Baynes. Petri

Star founders, in­ves­ti­ga­tors hud­dle around new Boston ac­cel­er­a­tor spot­light­ing young en­tre­pre­neurs

As a widely recognized biotech hub, Boston is undoubtedly one of the best places to start a new company at the frontier of biology and engineering. With a dense network of incubators, venture capitalists and talent, seasoned company founders can have their pick of partners and models launching their latest startups.

But for young, aspiring entrepreneurs, it’s a very different scene.

Big VC firms might hire you to work on their ideas instead of yours, and accelerators may not offer the kind of deep technical expertise and guidance needed to make it in the field.

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From part­ner to knight in shin­ing ar­mor: Cas­tle Creek to buy Fi­bro­cell

In April, Castle Creek swooped in to partner with the embattled gene and cell therapy Fibrocell to shepherd its lead gene therapy for a type of “butterfly” disease into late-stage development. Now, the New Jersey-based dermatology company is acquiring its partner in a deal worth $63.3 million.

Pennsylvania-based Fibrocell last year initiated a review of strategic alternatives, including a sale.