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.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Mark Mal­lon charts post-Iron­wood course by tak­ing CEO job at NeoGe­nomics; Glax­o­SmithK­line vet Feng Ren joins In­sil­i­co as CSO

Mark Mallon steps aside at Ironwood on March 12 after close to two years at the helm, and he already has a new change of scenery squared away. Beginning April 19, Mallon takes charge as CEO of cancer-focused genetic test maker NeoGenomics out of Fort Myers, FL while his predecessor, Douglas VanOort, is retiring after 12 years as NeoGenomics’ chairman and CEO.

It’s a fresh start for Mallon after what will amount to a tumultuous 23 months as Ironwood’s chief executive. Last year was marked by trial failures that spelled double trouble, leaving the Ironwood cupboard bare: first, a Linzess reformulation for irritable bowel syndrome with diarrhea (IBS-D) in May, and then the drug IW-3718 for persistent acid reflux in September. After IW-3718’s discontinuation, Ironwood chopped its staff by 35%. On Feb. 8, Mallon announced his departure at Ironwood, with president Tom McCourt getting bumped up to interim CEO.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.