An­to­nio Gual­ber­to starts post-Ku­ra ca­reer at Ei­sai sub­sidiary H3; eF­FEC­TOR co-founder Siegfried Re­ich jumps to Turn­ing Point

→ Days af­ter Ku­ra On­col­o­gy an­nounced the de­par­ture of co-founder An­to­nio Gual­ber­to, we fi­nal­ly know where he wound up. Ei­sai sub­sidiary H3 Bio­med­i­cine has re­cruit­ed him as CMO to find­ing the right pa­tients to its four clin­i­cal-stage small mol­e­cule as­sets hit­ting ge­nom­ic dri­vers of can­cer.

“Chal­lenges of these and many oth­er pre­ci­sion med­i­cine ap­proach­es are on one hand tech­ni­cal — a need for ro­bust and pre­cise di­ag­nos­tics — and on the oth­er hand de­rived by the chal­lenge to al­ter stan­dard clin­i­cal prac­tice in set­tings where pa­tient screen­ing, e.g. by tu­mor DNA se­quenc­ing, is not stan­dard prac­tice,” he wrote to End­points News on his way back to Boston from Ei­sai’s Tokyo of­fices. “On­ly com­pelling clin­i­cal ac­tiv­i­ty can dri­ve clin­i­cians and pathol­o­gists to mod­i­fy stan­dard clin­i­cal prac­tice.”

Gual­ber­to was cred­it­ed with fig­ur­ing out the mech­a­nism of ac­tion for Ku­ra’s far­ne­syl trans­ferase in­hibitors and steer­ing them to the clin­ic. By dis­cov­er­ing CX­CL12 as a tar­get of their lead drug, tip­i­farnib, he an­swered a ques­tion that had been “unan­swered for more than a decade.”

“Tip­i­farnib is a great ex­am­ple of clin­i­cal dis­cov­ery that start­ed with the ob­ser­va­tion from tri­al da­ta from the pri­or Janssen pro­gram that AML pa­tients with high bone mar­row tu­mor bur­den and low cir­cu­lat­ing blasts were par­tic­u­lar­ly sen­si­tive to tip­i­farnib,” he said.

His pre­vi­ous stints span EMD Serono, Take­da and Pfiz­er.

→ Sea­soned drug hunter Siegfried Re­ich has left eF­FEC­TOR, the biotech he co-found­ed to dis­cov­er se­lec­tive trans­la­tion reg­u­la­tors, to take up the CSO role at Turn­ing Point Ther­a­peu­tics.

“I have fol­lowed the progress Turn­ing Point has made, and was drawn to its fo­cus on drug dis­cov­ery and its work to ad­vance the pipeline,” Re­ich told End­points. “I was al­so im­pressed by the depth of its man­age­ment team and board, many of whom I have worked with be­fore.”

Turn­ing Point re­cent­ly got some val­i­da­tion in its next-gen­er­a­tion ki­nase in­hibitor plat­form in the form of an im­pres­sive over­all re­sponse rate among TKI-naïve ROS1+ non-small cell lung can­cer pa­tients, al­though there were lin­ger­ing safe­ty con­cerns.

Re­ich, an in­ven­tor of the TKI In­ly­ta from his Agouron days who’s al­so worked in the an­tivi­ral space at Pfiz­er (in­vent­ing the pro­tease in­hibitor Vira­cept) and lat­er jumped to Lil­ly Biotech Cen­ter, said he would hit the ground run­ning to iden­ti­fy new tar­gets and churn out new projects on the macro­cyclic plat­form.

He will build on four drug can­di­dates in the San Diego start­up’s pipeline that tar­get ROS1/TRK, MET/CSF1R/SRC, RET/SRC and ALK, re­spec­tive­ly.

— Am­ber Tong


→ Gilead has snagged for­mer Bris­tol-My­ers Squibb on­col­o­gy ex­ec Michael Quigley as SVP, re­search bi­ol­o­gy. In ad­di­tion to his time at Bris­tol-My­ers, Quigley al­so held po­si­tions at Janssen and Med­Im­mune. At the same time, the com­pa­ny has pro­mot­ed Lin­da Hig­gins, who joined the com­pa­ny in 2010, to the po­si­tion of SVP and head of ex­ter­nal in­no­va­tion.

Géral­dine Hon­net Bio­ther­a­pies In­sti­tute

→ French biotech Sen­so­ri­on — fo­cused on the treat­ment of hear­ing loss dis­or­ders — has tapped Géral­dine Hon­net as CMO. Hon­net joins the com­pa­ny from Généthon, where she was al­so CMO. Pre­vi­ous­ly, Hon­net held posts at Parex­el In­ter­na­tion­al, Janssen-Cilag (John­son & John­son) and Trans­gene.

Tay­lor Schreiber has tak­en over the reins as CEO at Take­dapart­nered I/O play­er Shat­tuck Labs, suc­ceed­ing Josi­ah Horn­blow­er. Schreiber, a co-founder of the com­pa­ny, was pre­vi­ous­ly CSO. Pri­or to Shat­tuck, Schreiber was the co-founder and sci­en­tif­ic ad­vi­sor of Pel­i­can Ther­a­peu­tics. Horn­blow­er will re­main with the com­pa­ny as ex­ec­u­tive chair­man of the board.

→ AskBio has en­list­ed AAV gene ther­a­py ex­pert An­na Tre­ti­ako­va as SVP of prod­uct de­vel­op­ment. Tre­ti­ako­va has spent near­ly a decade con­duct­ing re­search at the Uni­ver­si­ty of Penn­syl­va­nia Gene Ther­a­py Pro­gram, Pfiz­er Rare Dis­ease Re­search Unit and Swan­Bio Ther­a­peu­tics.

Pe­ter Hecht Cy­cle­ri­on

→ Nan­cy Thorn­ber­ry-led Kally­ope — fo­cused on the gut-brain ax­is — has wel­comed Pe­ter Hecht to the board of di­rec­tors. Hecht re­cent­ly left his po­si­tion as CEO of Iron­wood Phar­ma­ceu­ti­cals to head the com­pa­ny’s spin­out Cy­cle­ri­on Ther­a­peu­tics as CEO.

For­mer Foun­da­tion Med­i­cine CEO Troy Cox has hopped aboard the board of di­rec­tors at SOPHiA GE­NET­ICS as chair­man, re­plac­ing An­toine Duchateau, who will con­tin­ue to serve as a board mem­ber. Cox served as CEO for Foun­da­tion Med­i­cine be­gin­ning in 2017 up un­til the com­pa­ny was snatched up by Roche.

Af­ter scor­ing a new glau­co­ma drug ap­proval last March, Aerie Phar­ma­ceu­ti­cals has named Ni­na Ohara as di­rec­tor, mar­ket­ing. Most re­cent­ly, Ohara served at Ot­su­ka Phar­ma­ceu­ti­cals sub­sidiary Avanir Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny wel­comed Gre­go­ry Jones as di­rec­tor, tax. Jones pre­vi­ous­ly served at De­loitte Tax.

→ Bolt Ther­a­peu­tics has ap­point­ed Bris­tol-My­ers Squibb vet Nils Lon­berg to its sci­en­tif­ic ad­vi­so­ry board. Lon­berg cur­rent­ly serves as ex­ec­u­tive-in-res­i­dence at Canaan Part­ners.

→ Soft­ware de­vel­op­er for drug dis­cov­ery Optib­ri­um has ap­point­ed Tim Hohm as di­rec­tor of com­mer­cial busi­ness strat­e­gy and busi­ness de­vel­op­ment. Hohm hops over from No­vo Nordisk, where he was se­nior com­pet­i­tive in­tel­li­gence man­ag­er.

→ Ca­li­di Bio­ther­a­peu­tics — work­ing on on­colyt­ic virus-based im­munother­a­pies for can­cer — has en­list­ed Hee­hy­oung Lee to their board of di­rec­tors. Lee cur­rent­ly serves as a man­ag­ing part­ner at Lume­Bio and has held po­si­tions at Han­mi Phar­ma­ceu­ti­cals and Sor­ren­to Ther­a­peu­tics in the past.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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