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.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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What's next for Sarep­ta? A third DMD ap­proval, an­a­lysts pre­dict

What Sarepta wants, Sarepta usually gets.

In dramatic fashion on Thursday, the approval of Vyondys 53 — to treat a subset of Duchenne muscular dystrophy (DMD) patients — was unveiled, four months after the FDA’s initial rejection. With two drugs now approved on the basis of ~1% expression of dystrophin — the missing protein that causes DMD — Sarepta is in a prime position to take its third DMD drug to the regulator, analysts said, predicting healthier odds of success.

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Roche's triplet in­volv­ing Tecen­triq clears the PFS bar for melanoma when added to BRAF/MEK com­bo

In a “check the box” exercise, Roche said it has shown that adding Tecentriq to a combo of Cotellic and Zelboraf was effective in extending progression-free survival in melanoma patients compared to placebo plus the two drugs.

Patients with previously untreated BRAF V600 mutations were recruited to the Phase III study, dubbed IMspire150.

Cotellic (which was initially developed by Roche partner Exelixis) and Zelboraf are already approved to treat BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. While the latter blocks some BRAF kinases, the former is believed to help break treatment resistance by also inhibiting MEK1/2.

Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

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Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

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On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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