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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.