Igny­ta founder boosts team at his new can­cer start­up; Cy­tomx CMO hits the ex­it

Jonathan Lim Eras­ca

Igny­ta founder and ex-CEO Jonathan Lim is beef­ing up the team at Eras­ca, his new start­up ded­i­cat­ed to eras­ing can­cer. Genen­tech vet Gary Ye­ung has been pro­mot­ed to chief op­er­at­ing and fi­nan­cial of­fi­cer, leav­ing an open CBO role for David Chacko to step in. Chacko joins from Ver­sant Ven­tures, where, as a prin­ci­pal, he was cred­it­ed for ad­vanc­ing sev­er­al port­fo­lio com­pa­nies through fundrais­ing, busi­ness de­vel­op­ment and oth­er af­fairs. Les Brail, who has been work­ing on Neon’s per­son­al­ized neoanti­gen vac­cine, will be the VP of clin­i­cal de­vel­op­ment; Karen Gilmore, one of Lim’s old col­leagues at Igny­ta, has been tapped as VP of fi­nance.

Eras­ca has al­so as­sem­bled an R&D ad­vi­so­ry board: Bruce Roth (chem­istry), Dave Matthews (crys­tal­log­ra­phy), Greg Cos­ma (de­vel­op­ment), Paul Pear­son (ADME/PK), Jane Chang (tox­i­col­o­gy), James Fred­do (med­ical) and Lin­da Robert­son (reg­u­la­to­ry af­fairs).

Cy­tomX Ther­a­peu­tics has qui­et­ly part­ed ways with Rachel Humphrey, SVP and CMO. No rea­son was giv­en for her de­par­ture in the mid­dle of the week, which comes months af­ter Bris­tol-My­ers Squibb broke off a part­ner­ship on three col­lab­o­ra­tion dis­cov­ery tar­gets (though a Phase I/II for a part­nered CT­LA-4 Pro­body — in­tend­ed to be a safer, gen­tler ver­sion of Yer­voy — re­mains on track). Humphrey joined the biotech in 2015 af­ter stints at As­traZeneca and Bris­tol-My­ers, where she led clin­i­cal de­vel­op­ment of Yer­voy. 

→ Flush with $142 mil­lion in new fi­nanc­ing and part­ner­ship dol­lars, Fre­quen­cy Ther­a­peu­tics has brought in new ex­ecs to guide the up­com­ing Phase II study of its re­gen­er­a­tive drug for hear­ing loss. CMO Bill Chin, who jumped out of re­tire­ment more than a year ago to join the biotech, is mov­ing over to EVP of clin­i­cal and trans­la­tion­al sci­ence, with broad­er re­spon­si­bil­i­ties around the whole prog­en­i­tor cell ac­ti­va­tion (PCA) plat­form. Dana Hilt will as­sume that role, in which he will al­so es­tab­lish oth­er ap­pli­ca­tions of the tech, in­clud­ing a re­myeli­na­tion pro­gram in mul­ti­ple scle­ro­sis. His back­ground in neu­rol­o­gy and CNS drug de­vel­op­ment — ac­crued at Lyso­so­mal Ther­a­peu­tics, Fo­rum Phar­ma, Am­gen and oth­ers — will bol­ster Fre­quen­cy’s for­ay in­to de­gen­er­a­tive dis­eases, ac­cord­ing to CEO David Lucchi­no. Oth­er ap­point­ments place Mod­er­na alums Jeff Hrkach as SVP of tech­ni­cal de­vel­op­ment and Ja­son Glashow as SVP of cor­po­rate af­fairs.

uniQure made some changes to its lead­er­ship team with the pro­mo­tion of Sander van De­ven­ter to ex­ec­u­tive vice pres­i­dent, re­search and prod­uct de­vel­op­ment and Gen­zyme vet Alex Ku­ta to ex­ec­u­tive vice pres­i­dent, op­er­a­tions. With these changes, the com­pa­ny is elim­i­nat­ing the COO role, and Scott McMil­lan, the cur­rent hold­er of the job, will be re­tir­ing. Both van De­ven­ter and Ku­ta joined uniQure in 2017 as CSO and gen­er­al man­ag­er, Am­s­ter­dam; and SVP, reg­u­la­to­ry af­fairs, re­spec­tive­ly. Van De­ven­ter was a co-founder of uniQure’s pre­de­ces­sor Am­s­ter­dam Mol­e­c­u­lar Ther­a­peu­tics (AMT) in 1998 and pre­vi­ous­ly served on the com­pa­ny’s board of di­rec­tors. He is cur­rent­ly the op­er­at­ing part­ner at For­bion Cap­i­tal part­ners and pro­fes­sor of trans­la­tion­al gas­troen­terol­o­gy at Lei­den Uni­ver­si­ty Med­ical Cen­ter. Ku­ta pre­vi­ous­ly served stints at EMD Serono, AM­AG Phar­ma­ceu­ti­cals and Gen­zyme. Pri­or to those roles, he was the chief of the Cy­tokine and Gene Ther­a­py Branch in the Cen­ter for Bi­o­log­ics at the FDA. 

→ Boston-based Bio­four­mis has scooped up two Roche ex­ecs to grow its dig­i­tal ther­a­peu­tics busi­ness and health an­a­lyt­ics plat­form. John Varak­lis is trad­ing glob­al head of clin­i­cal op­er­a­tions for the chief strat­e­gy of­fi­cer job as Bio­four­mis seeks more phar­ma part­ners to lever­age its tech­nol­o­gy in­te­grat­ing phar­ma­cother­a­py with re­mote pa­tient mon­i­tor­ing and dig­i­tal prod­ucts. Pe­ter Braun — whose 28-year ca­reer at the Swiss phar­ma gi­ant cul­mi­nat­ed in a po­si­tion lead glob­al ac­cess strat­e­gy, health pol­i­cy and com­mu­ni­ca­tions — will be­come chief com­mer­cial of­fi­cer. In this new role he will con­tin­ue to fo­cus on com­mu­ni­cat­ing with pay­ers, health­care providers and pa­tients.

Com­plexa has wooed Clarus CMO Theodore Danoff to steer its lead drug can­di­date through late-stage de­vel­op­ment. As CMO, Danoff is ex­pect­ed to lever­age his clin­i­cal de­vel­op­ment knowl­edge across ther­a­peu­tic ar­eas to ush­er not just CXA-10 in pul­monary ar­te­r­i­al hy­per­ten­sion and fo­cal seg­men­tal glomeru­loscle­ro­sis but al­so oth­er tri­als of ni­trat­ed fat­ty acids to treat fi­brot­ic and in­flam­ma­to­ry dis­eases. 

→ Hav­ing laid low since its two ini­tial rounds of fi­nanc­ing last year, T cell ther­a­py play­er Torque is ready to make some moves on the clin­i­cal tri­al and cell man­u­fac­tur­ing fronts. And it’s re­cruit­ed Sok Cheng Soh as CFO to help ex­e­cute those plans while Ana Radel­je­vic is com­ing on board to man­age busi­ness op­er­a­tions. Be­tween Biover­a­tiv and Boston Sci­en­tif­ic, Soh has ac­cu­mu­lat­ed ex­pe­ri­ence build­ing tax and trea­sury ca­pa­bil­i­ties as well as bal­anc­ing fi­nan­cial risk and li­ais­ing with cap­i­tal mar­kets. Radel­je­vic, who had start­ed her own ad­vi­so­ry firm, has a re­sume that spans PerkinElmer, Sanofi/Gen­zyme and De­loitte.

→ A year af­ter Mil­len­do Ther­a­peu­tics’ — a com­pa­ny fo­cused on treat­ments for or­phan en­docrine dis­eases — re­verse merged with Ova­Science, the com­pa­ny has tapped Tama­ra Joseph to suc­ceed Jef­fery Brin­za as gen­er­al coun­sel and cor­po­rate sec­re­tary, as well as nam­ing Ryan Zei­dan as chief de­vel­op­ment of­fi­cer. Pri­or to join­ing Mil­len­do, Joseph served as gen­er­al coun­sel at En­zy­vant Ther­a­peu­tics and in the same role at In­Vi­vo Ther­a­peu­tics, Cu­bist Phar­ma­ceu­ti­cals, Mayne Phar­ma and Tran­skary­ot­ic Ther­a­pies (TKT). She played ad­vi­so­ry roles in Mayne Phar­ma’s ac­qui­si­tion by Hos­pi­ra and TKT’s sale to Shire. Zei­dan has served as Mil­len­do’s SVP of de­vel­op­ment since join­ing the com­pa­ny in 2018. Pri­or to Mil­len­do, he had stints at Cel­gene, No­var­tis On­col­o­gy, Boston Con­sult­ing Group and Ca­lan­do Phar­ma­ceu­ti­cals.

→ Con­sumer pack­aged goods cannabis com­pa­ny, Piv­ot Phar­ma­ceu­ti­cals — which is plan­ning to grow and ex­pand mar­kets in Cana­da, the US and the EU — has tapped Toni Ri­now as CEO. Ri­now has held var­i­ous lead­er­ship roles in which she head­ed ac­qui­si­tions across Cana­da, Latin Amer­i­ca, Eu­rope and In­dia. In ad­di­tion, CMO Wolf­gang Renz will be serv­ing as re­gion­al man­ag­er Eu­rope along with his cur­rent tasks. Renz was a for­mer cor­po­rate vice pres­i­dent at Boehringer In­gel­heim.

→ Cam­bridge, Mass­a­chu­setts-based, AVRO­BIO — cur­rent­ly fo­cused on the de­vel­op­ment of their gene ther­a­py, AVR-RD-01, in Fab­ry dis­ease — wel­comed Geor­gette Verdin as chief hu­man re­sources of­fi­cer. Verdin joins the com­pa­ny af­ter stints at No­var­tis In­sti­tutes of Bio­med­ical Re­search, Bio­gen, Ama­zon and Mi­crosoft

→ Com­put­er sci­en­tist Im­ran Haque has found a new home at Re­cur­sion as their vice pres­i­dent of da­ta sci­ence. Haque hops over to the role af­ter a stint as CSO of Freenome. Pri­or to his time at Freenome, Haque served in var­i­ous roles at Coun­syl, in­clud­ing vice pres­i­dent, sci­en­tif­ic af­fairs. 

Sher­ron Kell has hopped on board to Proven­tion Bio as SVP of clin­i­cal de­vel­op­ment. She will lead the an­ti-CD3 mon­o­clon­al an­ti­body PRV-031 (teplizum­ab) pro­gram — which was grant­ed break­through ther­a­py des­ig­na­tion — for the in­ter­cep­tion and pre­ven­tion of clin­i­cal type 1 di­a­betes. Most re­cent­ly, Kell served as the vice pres­i­dent at Im­pax Phar­ma­ceu­ti­cals (now Am­neal Phar­ma­ceu­ti­cals). She al­so brings ex­pe­ri­ence from John­son & John­son and No­var­tis to the role. 

Eli Lil­ly vet Fred La­ri­more is mak­ing the jump from Van­cou­ver, Wash­ing­ton-based Ab­Sci’s sci­en­tif­ic ad­vi­so­ry board to his new role as the com­pa­ny’s vice pres­i­dent, process de­vel­op­ment.  Ab­Sci is a syn­thet­ic bi­ol­o­gy com­pa­ny with an E. coli cell line for rapid and low-cost bio­man­u­fac­tur­ing of com­plex pro­tein ther­a­peu­tics. At Lil­ly, La­ri­more served as a re­search fel­low and se­nior sci­en­tif­ic leader. He over­saw the man­u­fac­tur­ing of Hu­mulin, Hu­ma­log, Hu­ma­t­rope, For­teo and re­com­bi­nant hu­man glucagon. Pre­vi­ous­ly, La­ri­more was the vice pres­i­dent of sci­en­tif­ic af­fairs and CSO of Cook Pharmi­ca. In ad­di­tion to La­ri­more’s ap­point­ment, Ab­Sci is plan­ning to make 14 ad­di­tion­al po­si­tions by the end of 2019. 

Ve­na­toRx Phar­ma­ceu­ti­cals — fo­cused on the dis­cov­ery of an­ti-in­fec­tives to treat mul­tidrug re­sis­tant bac­te­r­i­al in­fec­tions and oth­er hard-to-treat vi­ral in­fec­tions — made some new ad­di­tions to its lead­er­ship team with the ap­point­ments of Jen­nifer El­lis as SVP, qual­i­ty; Paul Mc­Gov­ern as vice pres­i­dent, med­ical sci­ences and Lau­ren Tor­net­ta as vice pres­i­dent, reg­u­la­to­ry af­fairs. El­lis joined Ve­na­toRx af­ter stints at TRA­CON, Trius Ther­a­peu­tics (ac­quired by Cu­bist Phar­ma­ceu­ti­cals), Pfiz­er, and Al­liance Phar­ma­ceu­ti­cals. Pri­or to his new role with the com­pa­ny, Mc­Gov­ern served as the vice pres­i­dent, clin­i­cal & med­ical af­fairs at Paratek Phar­ma­ceu­ti­cals, as well as a stint at Wyeth/Pfiz­er. Tor­net­ta was a for­mer reg­u­la­to­ry project man­ag­er of the di­vi­sion of anes­the­sia, anal­ge­sia and rheuma­tol­ogy prod­ucts at the FDA. She al­so served at Galera Ther­a­peu­tics, Pfiz­er, En­do Phar­ma­ceu­ti­cals and Nabi Bio­phar­ma­ceu­ti­cals pri­or to jump­ing aboard Ve­na­toRx. 

→ San Fran­cis­co Bay area-based Vee­va Sys­tems — provider in cloud-based soft­ware for life sci­ences clients — made the ad­di­tion of pres­i­dent and COO of TESARO (ac­quired by GSK in 2019), Mary Lynne Hed­ley, to the board of di­rec­tors. 

An­dreessen Horowitz-backed Shield Di­ag­nos­tics has wel­comed David Es­pos­i­to to its board of di­rec­tors, join­ing its mis­sion to bring pre­ci­sion med­i­cine to in­fec­tious dis­eases. Es­pos­i­to is the cur­rent CEO of Ann Ar­bor-based ONL Ther­a­peu­tics.

→ We found out Mon­day morn­ing where Levi Gar­raway was head­ed af­ter he left Eli Lil­ly as head of on­col­o­gy R&D a few days ago. Roche named Gar­raway as their new chief med­ical of­fi­cer, re­plac­ing San­dra Horn­ing, who they say is re­tir­ing from the com­pa­ny. Gar­raway made the shift to the Big Phar­ma world less than three years ago af­ter a dis­tin­guished aca­d­e­m­ic ca­reer with stints at the Dana-Far­ber Can­cer In­sti­tute and Har­vard Med­ical School. Lil­ly, though, gave him a fast ed­u­ca­tion in the highs and lows of drug de­vel­op­ment. Horn­ing, mean­while, had a 10-year stint at Roche/Genen­tech, where she start­ed out as head of on­col­o­gy R&D fol­low­ing her own aca­d­e­m­ic ca­reer, with 21 years at Stan­ford

Ca­dent Ther­a­peu­tics — cur­rent­ly in col­lab­o­ra­tion with No­var­tis $NVS to de­vel­op a neg­a­tive al­losteric mod­u­la­tor, now in Phase II for the treat­ment of treat­ment-re­sis­tant de­pres­sion — wel­comed John McBride on board as CFO. McBride jumps over from the same role at Syn­tim­mune, where he helped with the com­pa­ny’s sale to Alex­ion $ALXN. Pri­or to his time at Syn­tim­mune, McBride served as the COO and CFO at Tokai Phar­ma­ceu­ti­cals and had stints at Glouces­ter Phar­ma­ceu­ti­cals, Phar­ma­cia, Cy­toTher­a­peu­tics and Phytera. In ad­di­tion, the com­pa­ny an­nounced sev­er­al oth­er hires, in­clud­ing Min­nie Mild­woff, Vice Pres­i­dent, Reg­u­la­to­ry Af­fairs and Qual­i­ty As­sur­ance; Robert Gaffey, Vice Pres­i­dent, Fi­nance and Ad­min­is­tra­tion; Nicole Lu­osey, Vice Pres­i­dent, Strate­gic and Pro­gram Op­er­a­tions and Noah Good­man, Ex­ec­u­tive Di­rec­tor, Busi­ness De­vel­op­ment.

Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

Scott Gottlieb has another position to add to his lengthy roster of boards and advisory roles in the wake of his departure from the helm of the FDA.

He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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