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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.