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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

Back in May 2017, following an FDA rejection, TherapeuticsMD saw its share price plummet to the lowest levels in two years. The little Florida biotech eventually found its way back to the good side of regulators, scoring a curious OK a year later for its therapy preventing vaginal pain during sex. But the SEC is now accusing it of selectively disclosing nonpublic information in attempts to manipulate its stock.

In two instances in June and July of 2017, TherapeuticsMD allegedly violated the Regulation Fair Disclosure rule by sharing material information with certain sell-side analysts and not the public, resulting in a more favorable stock move than otherwise would be expected.

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Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin Bio Ventures and UBS Oncology Impact Fund in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.