Long­time Api­tope CEO Kei­th Mar­tin steps down; Clear­side Bio­med­ical taps Spark ex­ec as CMO

Hay­ley French

Kei­th Mar­tin is re­tir­ing from the CEO post at Api­tope, the Uni­ver­si­ty of Bris­tol spin­out he’s led from launch to clin­i­cal stage. While the biotech search­es for a per­ma­nent re­place­ment, Hay­ley French is step­ping up to the re­spon­si­bil­i­ties as the new­ly in­stalled COO. She will like­ly pre­side over an event­ful time Api­tope, with three new tri­als com­ing up for its au­toim­mune ther­a­pies in the next quar­ter. But she has had plen­ty of time to get fa­mil­iar with the pipeline in the past eight years, most re­cent­ly as CBO.

→ NDA-ready for its mac­u­lar ede­ma treat­ment, Clear­side Bio­med­ical $CLSD has re­cruit­ed Thomas Ciul­la from Spark Ther­a­peu­tics to be­come its CMO. As oph­thalmic strat­e­gy lead at the gene ther­a­py com­pa­ny, Ciul­la was cred­it­ed for defin­ing a med­ical strat­e­gy that sup­port­ed pi­o­neer­ing vi­sion loss ther­a­py Lux­tur­na. Ev­i­dent­ly up­beat about a po­ten­tial ap­proval, Clear­side has al­so tapped in­dus­try vet Thomas Craw­ford as VP, sup­ply chain, plan­ning the dis­tri­b­u­tion of supra­choroidal CLS-TA. Clear­side has for­mu­lat­ed this sus­pen­sion of the cor­ti­cos­teroid tri­am­ci­nolone ace­tonide for ad­min­is­tra­tion to the back of the eye.

Dol­ca Thomas

→ Sea­soned phar­ma ex­ec Dol­ca Thomas is tak­ing up the CMO post at new­ly pub­lic Prin­cip­ia Bio­phar­ma $PRNB to steer a late-stage pro­gram for its BTK in­hibitor. Hav­ing been in­volved with a dozen im­munol­o­gy prod­uct can­di­dates be­tween Bris­tol-My­ers Squibb, Pfiz­er and Roche, she will now spear­head a Phase III for PRN1008 in a chron­ic skin con­di­tion called pem­phi­gus. Her pre­de­ces­sor Steve Gourlay will cap his five-year tenure with a tran­si­tion pe­ri­od as se­nior med­ical ad­vis­er.

→ Af­ter spend­ing 13 years try­ing to crack T cell en­gi­neer­ing at Sang­amo Ther­a­peu­tics, Gary Lee has de­cid­ed to join Sen­ti Bio­sciences’ up­start crew at “the fore­front of next gen­er­a­tion adap­tive ther­a­pies.” As CSO, Lee is tasked with stew­ard­ing ap­pli­ca­tions of Sen­ti’s syn­thet­ic bi­ol­o­gy tech plat­form in­to the clin­ic, start­ing with pro­grams in sol­id and liq­uid tu­mors.

An­dreas Muhs is tak­ing a med­ical leave from AC Im­mune $ACIU. The CSO will pass his du­ties tem­porar­i­ly to his deputy, David Lowe, who will con­tin­ue the re­search on neu­rode­gen­er­a­tive dis­eases with some guid­ance from Muhs.

→ Just a month af­ter woo­ing Bri­an Gal­lagher from SR One to run its Boston of­fice, Abing­worth has poached SV Health In­vestors’ Jack­ie Grant to be a prin­ci­pal work­ing un­der him. Armed with $315 mil­lion the UK-based biotech fund raised in Ju­ly, the team will scout transat­lantic ven­ture in­vest­ments to­geth­er with col­leagues in Men­lo Park and Lon­don.

→ Bio­phar­ma­ceu­ti­cal com­pa­ny Cara Ther­a­peu­tics $CARA, which is de­vel­op­ing treat­ments for itchy skin, has hired Joana Goncalves as chief med­ical of­fi­cer, to re­place Joseph Stauf­fer, who is tran­si­tion­ing in­to a con­sult­ing role. Goncalves, who most re­cent­ly served as VP of med­ical af­fairs for der­ma­tol­ogy and neu­rol­o­gy at Cel­gene $CELG and worked on the biotech’s pso­ri­a­sis drug Ote­zla, is tasked with ex­e­cut­ing the late-stage de­vel­op­ment of Cara’s Ko­r­su­va, an ex­per­i­men­tal drug for chron­ic kid­ney dis­ease-as­so­ci­at­ed pru­ri­tus.

→ As­traZeneca vet Kevin Hor­gan is jump­ing over to Cam­bridge, MA-based Seres as its new CMO. “Kevin is an ac­com­plished drug de­vel­op­er with ex­ten­sive ex­pe­ri­ence suc­cess­ful­ly lead­ing nu­mer­ous mid- and late-stage clin­i­cal pro­grams to ap­proval. Seres’ R&D ef­forts are in­creas­ing­ly fo­cused on ear­ly and lat­er stage im­muno­log­i­cal in­di­ca­tions, and Kevin’s deep clin­i­cal back­ground in these ar­eas makes him very well suit­ed to lead our clin­i­cal de­vel­op­ment stud­ies,” said Seres CEO Roger Pomer­antz.

→ Hous­ton-based Mark­er Ther­a­peu­tics has built out its lead­er­ship team by giv­ing its sci­en­tif­ic founders some of­fi­cial ti­tles and hir­ing oth­er lo­cal tal­ents. Juan Ve­ra, a sci­en­tif­ic co-founder of Mark­er’s mul­ti-anti­gen T cell ther­a­peu­tic plat­form, has been named chief de­vel­op­ment of­fi­cer; Ann Leen, an­oth­er co-founder cred­it­ed for the Mul­ti­TAA T cell ther­a­py plat­form, will be chief sci­en­tif­ic of­fi­cer; Gen­er­al coun­sel Ken Mose­ley jumps from im­munother­a­py com­pa­ny Bel­licum, as does Tsvetelina Penche­va Hoang, the new VP of R&D.

→ A few months af­ter ex­it­ing No­var­tis’ US on­col­o­gy group to pick up the reins of Ax­cel­la, Bill Hin­shaw has con­vinced a for­mer col­league to make the same jump. Mark­ing an end to a 15-year ca­reer at the Big Phar­ma, Stephen Mitch­en­er will as­sume the role of CBO and SVP of the biotech, which is fo­cused on the nascent field of meta­bol­ic mod­u­la­tors.

→ With CFO Hen­rik Ju­uel leav­ing for Bavar­i­an Nordic, Swe­den’s Orexo has quick­ly pro­mot­ed Joseph De­Feo — who was head of fi­nance and op­er­a­tions in its US sub­sidiary — to the po­si­tion. Jo­hannes Doll, EVP and head of cor­po­rate de­vel­op­ment, will pick up the in­vestor re­la­tions por­tion of the job.  

→ Hav­ing worked in the re­gion­al of­fices of a num­ber of big multi­na­tion­al drug­mak­ers, Cheryl Tan is join­ing Sin­ga­pore-head­quar­tered Cerecin for a change. As head of com­mer­cial strat­e­gy, she’s ex­pect­ed to of­fer com­mer­cial guid­ance on the biotech’s neu­rol­o­gy ther­a­pies based on her ex­pe­ri­ence with Al­ler­gan, Acte­lion and Sanofi Gen­zyme, among oth­ers.

→ Can­cer im­munother­a­py de­vel­op­er Epi­Vax On­col­o­gy has ap­point­ed Do­minique Bridon chief tech­nol­o­gy of­fi­cer.

→ As Kala Phar­ma­ceu­ti­cals $KALA preps the launch of its first eye prod­uct and gears up for clin­i­cal de­vel­op­ment of an­oth­er, it’s brought in Shire vet Steven Zhang as VP of med­ical af­fairs.

→ Fol­low­ing Ar­a­vive’s re­verse merg­er with Ver­sar­tis, founder Ray Tabib­i­azar has found a new gig as SVP cor­po­rate de­vel­op­ment and busi­ness strat­e­gy at Twist Bio­science, where he will al­so man­age the bi­o­log­ics drug dis­cov­ery di­vi­sion.

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.