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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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