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.

Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M for a piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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New biotech Exalys, seek­ing to pre­vent post­op­er­a­tive delir­i­um, launch­es with $15 mil­lion in Se­ries A

An old group of former colleagues will be reuniting to lead a new biotech venture aimed at cultivating a portfolio to treat neuroinflammatory disorders.

Led by Rick Orr, who ran biotechs Adynxx and Alliqua Biomedical, the group is launching the startup Exalys on Thursday with $15 million in Series A funding from venture firms Catalys Pacific and Domain Associates. The nascent company’s first project will focus on preventing postoperative delirium, licensing a platform of EP4 receptors from Japanese pharma Eisai.

De­spite safe­ty, ef­fi­ca­cy con­cerns, FDA Ad­Com nar­row­ly rec­om­mends Mallinck­rodt drug

A day after the FDA detailed significant concerns about just how effective or safe an experimental Mallinckrodt liver drug was, an advisory committee decided by a single vote to recommend it for approval.

“I voted yes to approve, but I also wrote in, ‘but barely,’” Paul Ridker, a cardiologist at Brigham and Women’s Hospital and one of the panelists, said at the meeting, according to FierceBiotech. The vote was 8-7.

Sanjiv Patel, Relay CEO

Re­lay reaps $400M IPO wind­fall af­ter draw­ing the cur­tain on mo­tion-based drug de­sign pipeline

A red-hot venture market back in 2018 propelled Relay Therapeutics to a whopping $400 million crossover round. And now, the biotech is riding on a red-hot IPO market to a public debut that brought in the same exact amount.

The $400 million raise breaks down to 20 million shares sold at $20 each — above even the amended proposed range of $16 to $18.

It’s also double what Relay had penciled in with the initial S-1 filing, in yet another illustration that those figures are often nothing more than a placeholder these days.