Jose Car­los 'JC' Gutiér­rez-Ramos hits the ex­it at Syn­log­ic; Rich Hey­man pass­es Oric reins to ex-Igny­ta CFO

Jose Car­los Gutier­rez-Ramos

→ An abrupt res­ig­na­tion by pres­i­dent and CEO Jose Car­los Gutiér­rez-Ramos has left Syn­log­ic $SYBX in the hands of CMO Aoife Bren­nan. JC Gutiér­rez-Ramos ex­its the Cam­bridge biotech al­most ex­act­ly a year af­ter he or­ches­trat­ed its re­verse merg­er on­to Nas­daq, leav­ing be­hind an op­er­a­tion with two on­go­ing Phase I stud­ies and one dis­cov­ery pact with Ab­b­Vie, all built up­on Syn­log­ic’s spe­cial­ty in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics. No rea­sons were giv­en for his de­par­ture, which comes three years af­ter he joined from Pfiz­er, where he held a high-pro­file R&D job. Pe­ter Bar­rett is step­ping in­to the ex­ec­u­tive chair­man’s role to en­sure Bren­nan can bal­ance her in­ter­im ex­ec­u­tive du­ties with all the re­search, pre­clin­i­cal ac­tiv­i­ties and clin­i­cal tri­als un­der­way. Gutiér­rez-Ramos” will serve in an ad­vi­so­ry ca­pac­i­ty as need­ed.”

→ Hav­ing led Oric Phar­ma’s tran­si­tion from re­search to de­vel­op­ment stage, se­r­i­al en­tre­pre­neur Rich Hey­man fig­ured it’s time to pass the reins to a per­ma­nent CEO. En­ter Ja­cob Chacko, the for­mer Igny­ta CFO who helped grow the com­pa­ny from a val­u­a­tion of $50 mil­lion to $1.7 bil­lion — the price at which Roche bought it out. So while this will be his first time in the chief ex­ec­u­tive role, he brings to Oric both fundrais­ing ex­pe­ri­ence and knowl­edge about an ear­ly-stage on­col­o­gy com­pa­ny. (Be­fore Igny­ta, he worked as an in­vestor for pri­vate eq­ui­ty firm TPG Cap­i­tal.) For now, his pri­or­i­ty lies in pro­gress­ing the pipeline of drugs ad­dress­ing treat­ment re­sis­tance, es­pe­cial­ly lead can­di­date ORIC-101. Hey­man, who over­saw a $50 mil­lion Se­ries C fi­nanc­ing dur­ing his one-year-plus in­ter­im term, will stay on as board chair­man.

→ A start­up try­ing to de­vel­op a stem cell cure for type 1 di­a­betes has re­cruit­ed for­mer Ma­gen­ta ex­ec­u­tive Bas­tiano San­na — a guy best known for lead­ing the de­vel­op­ment of No­var­tis’ cell-based med­i­cines — to serve as the com­pa­ny’s new CEO. Cam­bridge-based Sem­ma Ther­a­peu­tics is bring­ing San­na in to re­place its in­ter­im CEO Eliz­a­beth Ston­er. San­na comes di­rect­ly from Ma­gen­ta — an­oth­er start­up de­vel­op­ing stem cell tech — where he was chief op­er­at­ing of­fi­cer. Be­fore that, San­na was an ex­ec­u­tive at No­var­tis’ cell and gene ther­a­py di­vi­sion, over­see­ing the de­vel­op­ment of CAR-T drugs.

→ Fol­low­ing its first pub­lic ap­pear­ance with $14 mil­lion in Se­ries A cash, Austin-based TFF Phar­ma­ceu­ti­cals an­nounced that it has tapped Glenn Mattes as CEO. A J&J vet and two-time biotech CEO, Mattes has been brought in for the long haul, trust­ed to take the biotech to com­mer­cial suc­cess. In­stead of an­tivi­ral ther­a­pies or can­cer treat­ments, how­ev­er, he will now fo­cus on TFF’s dry pow­der in­haler ver­sions of pul­monary drugs gen­er­at­ed with its name­sake, the Thin Film Freez­ing tech­nol­o­gy. He takes over from Robert Mills, who is now chair­man of the board.

David Moataze­di

→ Al­ler­gan aes­thet­ics chief David Moataze­di is leav­ing to take the helm of Evo­lus, a much small­er biotech de­vel­op­ing a ri­val to Botox. Evo­lus’ new drug DWP-450 (Prabot­u­linum­tox­inA) is un­der re­view. Moataze­di not­ed: “The team at Evo­lus has done a fan­tas­tic job in bring­ing for­ward what I be­lieve will be the most ex­cit­ing new prod­uct in aes­thet­ics. I look for­ward to work­ing with this tal­ent­ed group of pro­fes­sion­als and com­plet­ing the build out of a best in class lead­er­ship team.”

→ Six months in­to Daniel O’Con­nor’s tenure at On­cosec $ONCS, Punit Dhillon is phas­ing out even more from the biotech he co-found­ed and once helmed. In a con­sol­i­da­tion, O’Con­nor will now serve as both CEO and pres­i­dent — a role that for­mer­ly be­longed to Dhillon. Dhillon will, how­ev­er, re­main on the board.

→ In­di­cat­ing its dri­ve to gain mar­ket share in the gene en­gi­neer­ing ser­vices space, Hori­zon Dis­cov­ery has pro­mot­ed its head of com­mer­cial op­er­a­tions Ter­ry Pizzie to CEO, fill­ing a va­can­cy left by the de­par­ture of Dar­rin Dis­ley three months ago. Richard Vel­la­cott, who’s been shoul­der­ing most of the re­spon­si­bil­i­ties, will go back to just be­ing CFO. Be­fore join­ing Cam­bridge, UK-based Hori­zon last year and start­ing to build out its team, Pizzie had led com­mer­cial op­er­a­tions for Genetix and Bi­a­core.

Michael Stocum is step­ping down from Ini­va­ta, the liq­uid biop­sy com­pa­ny he’s led for four years, to make way for a new CEO “with a dif­fer­ent set of skills” as the Uni­ver­si­ty of Cam­bridge spin­out en­ters its “next stage of growth.” Stocum, for­mer­ly of GSK, found­ed and con­tin­ues to run a strat­e­gy con­sult­ing busi­ness called Per­son­al­ized Med­i­cine Part­ners.

→ A se­nior glob­al R&D leader at Genen­tech is leav­ing the biotech gi­ant for a new post at South San Fran­cis­co’s Atara Bio­ther­a­peu­tics. Di­et­mar Berg­er will join Atara $ATRA as glob­al head of R&D, tak­ing the com­pa­ny’s al­lo­gene­ic T cell treat­ments through the clin­ic. Berg­er is best known for his re­cent role at Genen­tech/Roche, where he’d been work­ing as se­nior vice pres­i­dent and glob­al head of prod­uct de­vel­op­ment with­in the com­pa­ny’s hema­tol­ogy and on­col­o­gy unit since 2014. There, he led med­ical strat­e­gy for Genen­tech’s port­fo­lio of can­cer med­i­cines, in­clud­ing glob­al fil­ings of ap­proved drugs like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. At Atara, he will man­age a slate of R&D pro­grams, in­clud­ing a CAR-T part­ner­ship with Juno co-founder Michel Sade­lain an­nounced just a day af­ter his ap­point­ment.

→ In the af­ter­math of a de­ci­sive PhII fail­ure for one in­di­ca­tion of its sole drug, Men­lo Ther­a­peu­tics $MN­LO has reshuf­fled its C-suite to divvy up ear­ly- and late-stage clin­i­cal re­spon­si­bil­i­ties. Paul Kwon, a Genen­tech vet who’s been CMO for the last two years, will now take on the role of CSO, iden­ti­fy­ing po­ten­tial new in­di­ca­tions for ser­lop­i­tant and run­ning ear­ly-stage tri­als. Mary Spell­man, pre­vi­ous­ly SVP of clin­i­cal de­vel­op­ment, has been tapped to man­age the plan­ning and ex­e­cu­tion of late-stage clin­i­cal pro­grams as CMO. The new ap­point­ments for Kwon and Spell­man, both of whom are der­ma­tol­o­gists, un­der­scores Men­lo’s con­vic­tion for its drug in the pruri­go nodu­laris itch and pso­ri­a­sis itch in­di­ca­tions, though it does have Phase II da­ta for its re­frac­to­ry cough pro­gram com­ing up lat­er this year.

Au­dentes Ther­a­peu­tics COO Na­tal­ie Holles is adding “pres­i­dent” to her ti­tle. Her new man­date cov­ers day-to-day op­er­a­tions of the com­pa­ny $BOLD, in­clud­ing R&D, man­u­fac­tur­ing, pro­gram man­age­ment and cor­po­rate de­vel­op­ment. For Au­dentes, this marks an evo­lu­tion in their lead­er­ship struc­ture, part of a quest to bring gene ther­a­py for rare dis­eases to the mar­ket.

→ As Third Rock-backed Tan­go Ther­a­peu­tics be­gins to trans­late its CRISPR-based dis­cov­ery plat­form in­to next-gen im­muno-on­col­o­gy ther­a­peu­tics, it has pro­mot­ed a found­ing staffer to the C-suite and brought in an­oth­er ex­ec from No­var­tis. New CSO Alan Huang and SVP of phar­ma­ceu­ti­cal sci­ences Charles Davis share roots in No­var­tis In­sti­tutes for Bio­Med­ical Re­search; Huang lat­er went on to be­come a con­sul­tant at Third Rock. To­geth­er with Davis, a GSK vet of 20 years, he will work to build a pipeline for the young biotech.

→ On the brink of mov­ing its fi­bro­sis drugs in­to the clin­ic, Pli­ant Ther­a­peu­tics has brought in Éric Lefeb­vre from Al­ler­gan to lead de­vel­op­ment strat­e­gy and clin­i­cal op­er­a­tions for its prod­uct can­di­dates. As CMO, over time, Lefeb­vre is ex­pect­ed to chan­nel the many skills he’s ac­crued at To­bi­ra, Janssen and GSK — rang­ing from de­vel­op­ment and med­ical af­fairs to com­mer­cial­iza­tion. He will do all this un­der the lead­er­ship of new­ly in­stalled board chair­man Hoy­oung Huh, a for­mer McK­in­sey part­ner and vet­er­an board di­rec­tor who will guide the man­age­ment team on high-lev­el busi­ness strat­e­gy.

Flex­ion Ther­a­peu­tics $FLXN has found a suc­ces­sor for re­tir­ing CFO Fred­er­ick Driscoll in David Arkowitz. Be­tween Vis­ter­ra, AM­AG Phar­ma and Mer­ck, Arkowitz has served in COO, CBO and con­troller roles in ad­di­tion to be­ing the top fi­nan­cial per­son. Ex­ecs al­so liked his com­mer­cial ex­pe­ri­ence, giv­en that Flex­ion is still rel­a­tive­ly new in the mar­ket­ing game for its in­jectable drug for os­teoarthri­tis-re­lat­ed knee pain.

→ Look­ing to bring its cell-based im­plant to the US, Cana­da’s Ser­no­va has hired Sean Hod­gins to as­sist the CEO in ex­e­cut­ing the com­pa­ny’s busi­ness de­vel­op­ment and cap­i­tal mar­ket strate­gies. The new CFO man­aged a cou­ple of Nas­daq IPOs while work­ing in the US and has han­dled sev­er­al Cana­di­an list­ings and CFO jobs since then. He re­places Scott Langille.

→ Tap­ping what they see as a boom in stem cell-based re­gen­er­a­tive med­i­cine, Tel Aviv-based Cel­lect Biotech­nol­o­gy $APOP is open­ing a US cen­ter of op­er­a­tions and wooed a for­mer GE Health­care ex­ec to lead it. An­drew Sabati­er’s of­fi­cial ti­tle will be chief busi­ness of­fi­cer, in which he will lever­age his pre­vi­ous ex­pe­ri­ence mar­ket­ing raw ma­te­ri­als to a gen­er­a­tion of biotechs de­vel­op­ing new ther­a­pies.

→ Mov­ing from one women’s health bio­phar­ma to the next, John Fair has tak­en a CBO job at Daré Bio­science $DARE. The San Diego com­pa­ny is de­vel­op­ing a non-hor­mon­al con­tra­cep­tive and a drug for fe­male sex­u­al arousal dis­or­der us­ing the ac­tive in­gre­di­ent in Vi­a­gra; Fair will be seek­ing part­ner­ships for these and oth­er re­pro­duc­tive prod­uct can­di­dates in the works.

→ Fol­low­ing a four-month search, Sy­neos Health con­clud­ed that its in­ter­im CFO Ja­son Meg­gs is the best per­son for the job left be­hind by Greg Rush. For­mer­ly an EVP and CFO of com­mer­cial so­lu­tions, Meg­gs joined INC Re­search back be­fore it merged with In­Ven­tiv Health, cre­at­ing an in­te­grat­ed com­pa­ny $SYNH with both con­tract re­search and con­tract com­mer­cial­iza­tion ca­pa­bil­i­ties.

Adare Phar­ma­ceu­ti­cals’ Prince­ton, NJ head­quar­ters is bub­bling with ac­tiv­i­ty. En­do Phar­ma vet Robert Rush is join­ing as VP, fi­nance and CFO; Ajay Damani has left Lon­za to lead Adare’s phar­ma­ceu­ti­cal tech­nolo­gies busi­ness unit as a VP; and Giuseppe Di Vin­cen­zo has been pro­mot­ed to VP, strat­e­gy. To­geth­er, they will help bal­ance an op­er­a­tion that fea­tures both in-house R&D and clin­i­cal ser­vices. Joseph Del Buono, who used to have Rush’s job, has re­signed to pur­sue oth­er op­por­tu­ni­ties.

→ Leav­ing be­hind a clin­i­cal pro­gram lead po­si­tion at Bris­tol-My­ers Squibb’s vi­rol­o­gy unit, Stephanie Noviel­lo is now the VP of clin­i­cal de­vel­op­ment at an­tibi­otics mak­er Mo­tif Bio. Noviel­lo will stay — at least ini­tial­ly — laser-fo­cused on the EMA sub­mis­sion for Mo­tif Bio’s Phase III Gram-pos­i­tive bac­te­r­i­al in­fec­tion drug iclaprim.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.