Pfiz­er spin­out woos Ot­su­ka vet Ray­mond Sanchez to lead CNS pipeline work; Joe An­der­son re­turns to Ar­ix helm

Ray­mond Sanchez

→ Four months af­ter plop­ping it­self down in the cen­ter of the neu­ro­sciences field with a pipeline from Pfiz­er and $350 mil­lion in launch cash from Bain Cap­i­tal, Cerev­el Ther­a­peu­tics has re­cruit­ed a sea­soned cen­tral ner­vous sys­tem drug de­vel­op­er to be­come its CMO. Ray­mond Sanchez, who jumps from Ot­su­ka, is tasked with shep­herd­ing Cerev­el’s Parkin­son’s (dopamine D1 ag­o­nist) and epilep­sy (GA­BA A pos­i­tive mod­u­la­tor) pro­grams in­to Phase III. At the Japan­ese phar­ma, Sanchez over­saw CNS work at Avanir among oth­er re­spon­si­bil­i­ties.

→ Af­ter a brief stint as chief in­vest­ment of­fi­cer, Joe An­der­son is re­turn­ing to his CEO role at biotech start­up builder Ar­ix Bio­science. The for­mer Abing­worth part­ner was first ap­point­ed to the helm in 2016, but switched his fo­cus last Sep­tem­ber to groom the in­vest­ment team and port­fo­lio — some­thing he will con­tin­ue de­vot­ing re­sources to as the Lon­don-based com­pa­ny shifts to­ward a “lean­er” or­ga­ni­za­tion. As part of the tran­si­tion, Jonathan Pea­cock will ex­change his ex­ec­u­tive chair­man badge for the non-ex­ec­u­tive ti­tle, and his for­mer deputy Christo­pher Evans will re­tire from the board.

Dar­rin Dis­ley

→ Se­r­i­al en­tre­pre­neur and for­mer Hori­zon Dis­cov­ery CEO Dar­rin Dis­ley has tak­en the chief ex­ec­u­tive role at Cell Mo­gri­fy, a Cam­bridge, Eng­land-based start­up that just scored $3.7 mil­lion seed fund­ing to pur­sue its work on di­rect cel­lu­lar con­ver­sion. “Di­rect re­pro­gram­ing be­tween ma­ture hu­man cell types” with­out go­ing through a pluripo­tent stem cell or prog­en­i­tor cell state, Dis­ley said, “is a holy grail of re­gen­er­a­tive med­i­cine and phar­ma­ceu­ti­cal ap­pli­ca­tions,” es­pe­cial­ly as the cell ther­a­py field ex­plodes. The new CEO is al­so an in­vestor in the com­pa­ny along­side Ahren In­no­va­tion Cap­i­tal and 24Hay­mar­ket.

Rachelle Jacques

Alex­ion’s Rachelle Jacques is jump­ing ship to an­oth­er rare dis­ease biotech with a big pro­mo­tion: CEO of En­zy­vant Sci­ences, which was forged out of Vivek Ra­maswamy’s pro­lif­ic shop at Roivant back in 2016. Jacques has re­placed Alvin Shih — who was ap­point­ed months af­ter the for­ma­tion of En­zy­vant — as the com­pa­ny preps for the com­mer­cial roll out of RVT-802, a re­gen­er­a­tive ther­a­py de­signed to re­con­sti­tute the im­mune sys­tem to treat pri­ma­ry im­mune de­fi­cien­cy re­sult­ing from con­gen­i­tal athymia. She pre­vi­ous­ly served as se­nior VP and glob­al fran­chise head of com­ple­ment at Alex­ion, and has al­so worked with Shire, Bax­al­ta, Bax­ter and Dow Corn­ing.

Rosa­mond Dee­gan is step­ping down as pres­i­dent and chief busi­ness of­fi­cer at Bi­cy­cle Ther­a­peu­tics, trig­ger­ing a pro­mo­tion and a new hire to fill the two po­si­tions. Lee Kalows­ki, the biotech’s CFO, will be­come pres­i­dent of its US op­er­a­tions (it has of­fices in both Cam­bridges across the At­lantic). Mean­while, Pe­ter Leone jumps from Ar­row­head Phar­ma to lead busi­ness de­vel­op­ment ef­forts for Bi­cy­cle’s bi­cyclic pep­tide plat­form.

Roche-part­nered gene ther­a­py com­pa­ny 4D Mol­e­c­u­lar Ther­a­peu­tics is stack­ing up its C-suite with a string of ap­point­ments and pro­mo­tions. Fred Ka­mal is com­ing on board as chief tech­ni­cal of­fi­cer af­ter over­see­ing qual­i­ty and reg­u­la­to­ry CMC for Avex­is as well as Juno. Au­gust Moret­ti, for­mer­ly of As­ser­tio Ther­a­peu­tics and Alexza Phar­ma­ceu­ti­cals is the new CFO. Pe­ter Fran­cis and There­sa Janke have been pro­mot­ed to chief med­ical of­fi­cer and chief op­er­at­ing of­fi­cer re­spec­tive­ly; Fran­cis is an oph­thalmic ge­net­ics ex­pert while Janke is a found­ing mem­ber of the com­pa­ny.

→ As Red­Hill Bio­phar­ma $RDHL gears up for a po­ten­tial US launch of its an­tibi­ot­ic Tal­i­cia,  it’s tapped Rick Scrug­gs as COO of its US op­er­a­tions. A board mem­ber since 2016, Scrug­gs learned the ropes of drug com­mer­cial­iza­tion at Sal­ix Phar­ma un­til Valeant bought it up. The Is­raeli biotech is plot­ting a fourth quar­ter roll­out for Tal­i­cia, which re­cent­ly re­port­ed a Phase III suc­cess in erad­i­cat­ing H. py­lori in­fec­tion.

Doug Williams has wooed a for­mer Bio­gen col­league to his start­up team at Co­di­ak Bio­Sciences. An­drea Di­Fabio has been named chief le­gal of­fi­cer, a post she al­so oc­cu­pied re­cent­ly at Biover­a­tiv (now a Sanofi sub­sidiary). Aside from her le­gal ex­per­tise, Di­Fabio is al­so ex­pect­ed to con­tribute to cor­po­rate strat­e­gy and trans­ac­tion­al dis­cus­sions, Williams said.

→ Fol­low­ing sev­er­al pacts with high pro­file part­ners on its RNAi pro­grams, Dicer­na $DR­NA is beef­ing up its lead­er­ship team. Hard­ean Ach­neck, a for­mer CMO at stem cell ther­a­py de­vel­op­er He­mo­stemix, is the new VP, head of med­ical de­vel­op­ment; Paratek alum Regi­na DeTore Paglia has been ap­point­ed as SVP of hu­man re­sources; and new head of cor­po­rate com­mu­ni­ca­tions Re­bec­ca Pe­ter­son brings two decades of ex­pe­ri­ence from the likes of Mil­len­ni­um, Alk­er­mes and Sanofi Gen­zyme.

Log­icBio Ther­a­peu­tics has re­cruit­ed Ken­neth Hut­tner from Biover­a­tiv to its ef­fort treat­ing rare dis­eases with gene edit­ing. As SVP, head of clin­i­cal de­vel­op­ment, Hut­tner will play a key role in ad­vanc­ing the com­pa­ny’s $LOGC lead pro­gram for methyl­malonic acidemia in­to the clin­ic.

→ Hav­ing lost a bid (and a for­tune) in a run for a New Jer­sey Sen­ate seat last fall, for­mer Cel­gene CEO Bob Hug­in is mak­ing a leap back in­to biotech. He is join­ing the board of Al­ler­gan $AGN at a time the com­pa­ny, un­der pres­sure from the hedge fund Ap­paloosa LP to di­vide the role of chair­man and CEO, is slow­ly thaw­ing to the idea of re­vamp­ing its lead­er­ship struc­ture. His ap­point­ment, though, has on­ly in­spired a back­lash from the ac­tivist in­vestor, which de­scribed its as “a lame at­tempt to de­flect pres­sure through to­ken mea­sures.”

Gos­samer founder Fa­heem Has­nain (of Re­cep­tos fame) is tak­ing over the board chair­man seat at Mi­rati Ther­a­peu­tics as Rod­ney Lappe re­tires from the ge­net­ics-dri­ven can­cer drug de­vel­op­er.  

Kather­ine High, co-founder and head of R&D at gene ther­a­py pi­o­neer Spark Ther­a­peu­tics, is one of two pro­posed new mem­bers join­ing the board of CRISPR Ther­a­peu­tics. The biotech, which counts it­self a fron­trun­ner in race to de­vel­op ther­a­pies with its name­sake gene edit­ing tool, has al­so in­vit­ed Biover­a­tiv CFO John Greene to be a di­rec­tor.

→ In a push to raise its pro­file glob­al­ly, Dis­cov­ery Park — a sci­ence cam­pus based in the south­east­ern part of Eng­land — has ap­point­ed Chris Broom as head of busi­ness de­vel­op­ment.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.