Akre­via scoops ex-Ar­sa­nis chief René Rus­so as CEO; Scott Got­tlieb jumps back in­to in­dus­try; Seat­tle Ge­net­ics raids As­traZeneca for CCO

René Rus­so Akre­via Ther­a­peu­tics

→ Months af­ter re­sign­ing from Ar­sa­nis — now rel­e­gat­ed to biotech his­to­ry books af­ter a re­verse merg­er with X4 Phar­maRené Rus­so has land­ed her next CEO gig at Akre­via Ther­a­peu­tics. The new role will shift her at­ten­tion from an­ti-in­fec­tives to im­muno-on­col­o­gy, but she will lean on her ex­pe­ri­ence scal­ing up biotech op­er­a­tions from an ear­ly stage. Backed by F-Prime Cap­i­tal and At­las Ven­ture, Akre­via em­ploys plat­form tech that pack­ages a CT­LA4 in­hibitor in a way that the an­ti­body would be in­ac­tive un­til it reach­es the tu­mor mi­croen­vi­ron­ment.

Scott Got­tlieb Twit­ter

→ Just a lit­tle more than a month af­ter his sur­prise ex­it from the FDA — sug­gest­ing he want­ed to spend more time with his fam­i­ly in Con­necti­cut, Scott Got­tlieb is jump­ing back in­to the mon­ey side of the in­dus­try and re­join­ing Wash­ing­ton DC-based New En­ter­prise As­so­ci­ates as a full-time in­vest­ing part­ner, where he ex­pects to start back­ing biotech star­tups and sit­ting on boards again.

 

Robin Tay­lor Seat­tle Ge­net­ics

Seat­tle Ge­net­ics $SGEN has raid­ed the top ranks of As­traZeneca $AZN for its first chief com­mer­cial of­fi­cer, Robin Tay­lor. Tay­lor’s stint at As­traZeneca last­ed 7 months, and pri­or to jump­ing to the com­pa­ny, he led the can­cer im­munother­a­py fran­chise at Roche’s Genen­tech for close to 18 years.

“Robin will play a key role in ex­tend­ing our com­mer­cial ex­e­cu­tion across six Ad­cetris lym­phoma in­di­ca­tions, while prepar­ing for the po­ten­tial launch of en­for­tum­ab ve­dotin and lead­ing our glob­al com­mer­cial­iza­tion strat­e­gy for pos­si­ble fu­ture prod­ucts, such as tu­ca­tinib,” not­ed Seat­tle Ge­net­ics CEO Clay Sie­gall.

David Apelian Twit­ter

→ Cur­rent COO and ex­ec­u­tive med­ical of­fi­cer of late-stage Eiger Bio­Phar­ma­ceu­ti­cals, David Apelian, will be step­ping down ef­fec­tive June 14, 2019. Apelian will join a pri­vate biotech as its CEO. Apelian’s de­par­ture is hap­pen­ing while the com­pa­ny’s Phase III pro­gram for ion­a­farnib — a preny­la­tion in­hibitor for the treat­ment of He­pati­tis Delta Virus (HDV) in­fec­tion — is be­ing prepped for an NDA and MAA to treat Hutchin­son-Gil­ford Prog­e­ria Syn­drome (HG­PS or Prog­e­ria) and Progeroid Laminopathies, with plans to file in 2019. Apelian will con­tin­ue to serve on the com­pa­ny’s board of di­rec­tors.

Pamela Gar­zone Scripps Re­search

→ The drug de­vel­op­ment arm of Scripps Re­search, Cal­i­br, has named Pamela Gar­zone as its CMO. Gar­zone has pre­vi­ous­ly served as vice pres­i­dent with­in the ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er $PFE as well as oth­er lead­er­ship roles. Cal­i­br is cur­rent­ly de­vel­op­ing mul­ti­ple drug can­di­dates, such as KA34 — a po­ten­tial os­teoarthri­tis ther­a­py that is cur­rent­ly in a Phase I hu­man clin­i­cal tri­al stage, and lat­er this year the com­pa­ny plans to sub­mit IND ap­pli­ca­tions for two can­cer ther­a­pies.

Mar­tin Tred­er Af­fimed

Af­fimed $AFMD has part­ed ways with CSO Mar­tin Tred­er just as the Ger­man biotech ex­e­cutes a pipeline cleanup and nar­rows its fo­cus. Its AFM11 pro­gram got in­to trou­ble with the FDA last Oc­to­ber due to a pa­tient death and two life-threat­en­ing episodes, and reg­u­la­tors re­cent­ly in­formed them that the Phase I tri­al can­not re­sume with­out more da­ta. CEO Adi Hoess notes that he has a strong team and is in no rush, if ever, to re­place Tred­er — who re­mains as a con­sul­tant. In the mean­time, COO Wolf­gang Fis­ch­er will over­see the dis­cov­ery and pre­clin­i­cal ef­forts.

Di­nah Sah Voy­ager Ther­a­peu­tics

→ Cam­bridge, Mass­a­chu­setts-based clin­i­cal-stage gene com­pa­ny, Voy­ager Ther­a­peu­tics an­nounced the re­tire­ment of its CSO Di­nah Sah and the ex­pan­sion of Omar Khwa­ja’s cur­rent role as CMO to now in­clude head of R&D. Both changes will be ef­fec­tive on June 28, 2019. Sah will con­tin­ue to serve as a con­sul­tant to the com­pa­ny and will al­so join its sci­en­tif­ic ad­vi­so­ry board.  

Mor­gan Sheng Genen­tech

Mor­gan Sheng is re­turn­ing to acad­e­mia fol­low­ing a decade at Roche’s Genen­tech. As VP of neu­ro­science, he spear­head­ed re­search projects dig­ging in­to new treat­ments for neu­rode­gen­er­a­tive dis­eases and pain. He now takes that back to MIT, al­beit in some­what dif­fer­ent po­si­tions than when he left — core mem­ber at the Broad In­sti­tute, and co-di­rec­tor of the Stan­ley Cen­ter for Psy­chi­atric Re­search — with a clear aim to ad­vance new ways to study, di­ag­nose and treat men­tal ill­ness.

Kirk Christof­fersen Linkedin

→ Well on its way in the clin­ic, an­ti-CD47 play­er Arch On­col­o­gy is ready to look be­yond its lead as­set for op­por­tu­ni­ties to grow. Kirk Christof­fersen has been tapped for the new­ly-cre­at­ed chief busi­ness of­fi­cer role, re­spon­si­ble for cor­po­rate strat­e­gy. Jump­ing from Com­pu­gen (pre­ced­ed by a 10-year run at GlobeIm­mune) Christof­fersen joins Arch short­ly af­ter it banked $50 mil­lion in Se­ries B cash, al­low­ing it to ex­pand both the cor­po­rate/clin­i­cal de­vel­op­ment team in the Bay Area and the re­search group at St. Louis.

Greg Rys­lik Linkedin

→ Cam­bridge, Mass­a­chu­setts-based Cel­sius Ther­a­peu­tics — start­ed in 2018 and backed by Third Rock Ven­tures and GV (for­mer­ly Google Ven­tures) — an­nounced its first key lead­er­ship ap­point­ments. Greg Rys­lik has joined the com­pa­ny as its chief da­ta of­fi­cer, and Michael Boret­ti has joined as its CBO.

Michael Boret­ti Linkedin

“Over the past year, we have been build­ing our team and as­sem­bling an in­te­grat­ed, in­dus­tri­al-scale plat­form that com­bines sin­gle-cell ge­nomics, ma­chine learn­ing, deep bi­ol­o­gy and drug dis­cov­ery, which has en­abled Cel­sius to ad­vance its un­der­stand­ing of the spe­cif­ic cells and ge­net­ic dri­vers that could play a key role in au­toim­mune dis­eases and can­cer,” said Alex­is Borisy, chair­man of Cel­sius.

→ Af­ter an­nounc­ing that it had en­tered the bio­me­chan­ics mar­ket launch­ing op­er­a­tion in Min­neapo­lis, Min­neso­ta, Subio­Med has now made ad­di­tions to its man­age­ment team. Patrick Kull­mann joins the com­pa­ny as CEO and board mem­ber af­ter his re­cent stint as COO and pres­i­dent for Medovex Corp.

Patrick Kull­mann Linkedin

Kull­mann has al­so served lead­er­ship po­si­tion at J&J, Boston Sci­en­tif­ic and Medtron­ic and mul­ti­ple start-up med­ical tech­nol­o­gy com­pa­nies. Bri­an Bowen joins the com­pa­ny as ex­ec­u­tive VP and board mem­ber with 32 years of ex­pe­ri­ence in mar­ket­ing strat­e­gy and lead­er­ship. Ad­di­tion­al­ly, John Deedrick — co-founder and ex­ec­u­tive chair­man of Ac­tivOrtho, co-founder and di­rec­tor of DyaMX, co-Founder and di­rec­tor of CHIP II and Pres­i­dent of CHIP So­lu­tions — and Mar­tin Emer­son — pres­i­dent and CEO of Mon­teris Med­ical — have joined the com­pa­ny’s board.

Karin Schmitt Linkedin

→ UK- based com­pa­ny Mo­gri­fy has re­lo­cat­ed to the Bio-In­no­va­tion Cen­tre at the Cam­bridge Sci­ence Park, af­ter adding 15 new staff mem­bers to its sci­en­tif­ic and man­age­ment teams, in­clud­ing Karin Schmitt as CBO and Joe Fos­ter as COO. The com­pa­ny says that “these new hires and fa­cil­i­ties will aid Mo­gri­fy in build­ing a scal­able in­fra­struc­ture to gen­er­ate IP around nov­el cell con­ver­sion to pow­er the de­vel­op­ment and man­u­fac­ture of new cell ther­a­pies across mul­ti­ple ther­a­peu­tic ar­eas.”

Rob Jack­son Linkedin

→ Ramp­ing up prepa­ra­tions for the po­ten­tial launch of RHB-105 — or Tal­i­cia as it’s al­ready call­ing the an­ti-in­fec­tive com­bat­ting H. Py­loriRed­Hill Bio­phar­ma has added three sea­soned ex­ec to its com­mer­cial team. Rob Jack­son, VP of mar­ket­ing, joins from Bioven­tus; Syn­er­gy Phar­ma’s for­mer VP of mar­ket ac­cess, Robert Gilkin, as­sumes the same role at Red­Hill; Steven Thomasian brings ex­pe­ri­ence from Kala and Cem­pra to his role as VP of sup­ply chain.

Je­re­my Grun­stein Linkedin

Am­gen $AMGN vet Je­re­my Grun­stein is the new VP of busi­ness de­vel­op­ment at Xen­cor $XN­CR, tasked with scout­ing new col­lab­o­ra­tions and deals for its an­ti­body tech, with sev­er­al po­ten­tial ap­pli­ca­tions in­clud­ing in bis­pe­cif­ic — re­cent­ly en­tic­ing Genen­tech to sign up for an al­liance.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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