John Mendlein leaves Mod­er­na for Flag­ship; Paul Sekhri to steer first xeno­trans­plan­ta­tion tri­als as eGe­n­e­sis CEO

John Mendlein is out at Mod­er­na just a year — a mo­men­tous year, no less, that saw Mod­er­na reap a $604 mil­lion IPO — af­ter be­com­ing pres­i­dent of the biotech uni­corn. The new role as ex­ec­u­tive part­ner at Flag­ship Pi­o­neer­ing brings him back to his “roots and pas­sion for cre­at­ing and grow­ing in­no­v­a­tive plat­form com­pa­nies,” he said in a state­ment. He will have stay an­oth­er six months as a con­sul­tant to Mod­er­na, where he led a cross-func­tion­al team prep­ping the com­pa­ny for the pub­lic mar­ket as well as cor­po­rate strat­e­gy, part­ner­ing, le­gal and in­tel­lec­tu­al prop­er­ty.

→ Af­ter hold­ing down the fort at eGe­n­e­sis as in­ter­im CEO for over a year, Julie Sun­der­land is pass­ing the role to Paul Sekhri and fo­cus­ing again on be­ing man­ag­ing di­rec­tor of Bio­mat­ics Cap­i­tal — one of the ma­jor back­ers for eGe­n­e­sis’ rad­i­cal gene edit­ing ap­proach to xeno­trans­plan­ta­tion. A one-time biotech founder, two-time CEO and three-time pres­i­dent, Sekhri has al­so held BD roles at Te­va and No­var­tis be­fore his most re­cent gig at Lyc­era. He is tasked with help­ing the biotech launch its first tests of trans­plant­i­ng mod­i­fied pig or­gans in­to hu­mans.

→ Months af­ter poach­ing As­traZeneca vet Kevin Hor­gan to serve as CMO at mi­cro­bio­me drug de­vel­op­er Seres, the Cam­bridge, MA-based com­pa­ny has el­e­vat­ed CFO Er­ic Shaff to the po­si­tion of CEO, to suc­ceed Roger Pomer­antz, who will re­main board chair­man. Shaff, who will con­tin­ue to serve as Seres’ prin­ci­pal fi­nan­cial of­fi­cer on an in­ter­im ba­sis, joined the com­pa­ny in 2014 as CFO and was giv­en the ad­di­tion­al po­si­tion of COO in ear­ly last year.

On­cono­va Ther­a­peu­tics is hand­ing Steven Frucht­man a sec­ond pro­mo­tion in less than a year as it dou­bles down on Phase III pro­grams for lead drug rigosert­ib and brings an­oth­er can­di­date in­to the clin­ic. Frucht­man, the for­mer CMO who re­cent­ly be­came pres­i­dent, will of­fi­cial­ly take over as CEO af­ter learn­ing close­ly from Ramesh Ku­mar. A hema­tol­o­gist by train­ing — fit­ting with On­cono­va’s pri­ma­ry fo­cus on myelodys­plas­tic syn­dromes — Frucht­man’s pre­vi­ous in­dus­try ex­pe­ri­ence spanned from Or­tho Biotech to No­var­tis.

→ As ArunA Bio looks to move its neur­al ex­o­some plat­form — with ap­pli­ca­tions as both ther­a­peu­tics and de­liv­ery ve­hi­cles — in­to clin­i­cal tri­als and in­dus­try col­lab­o­ra­tions, Steven Stice is switch­ing the CEO of­fice for a CSO role to fo­cus on R&D. His suc­ces­sor, Mark Sir­go, brings fresh ex­pe­ri­ence run­ning spe­cial­ty phar­ma BioDe­liv­ery Sci­ences, which shares a fo­cus on CNS with ArunA.

David Berman — Jeff Ru­mans for End­points News

Click on the im­age to see the full-sized ver­sion

David Berman, who un­til re­cent­ly was head of I/O re­search at As­traZeneca, has been bumped up to the top job in R&D at Im­muno­core, the TCR biotech which re­cent­ly re­cruit­ed Med­Im­mune chief Bahi­ja Jal­lal as CEO. Berman is a well known play­er in on­col­o­gy R&D and comes with cre­den­tials that in­cludes a lengthy stint along­side his new CEO at Im­muno­core, which spe­cial­izes in TCR work. Berman ac­tu­al­ly joined Im­muno­core, which is look­ing to reestab­lish its rep as a leader in its field wor­thy of a hefty uni­corn val­u­a­tion, last Sep­tem­ber ahead of a ma­jor re­vamp. He took over the lead role for the com­pa­ny’s top pro­gram for the late-stage ef­fort on IM­Cgp100.

Omar Khwa­ja has jumped from his post as glob­al head of Roche’s neu­ro­science trans­la­tion­al med­i­cine group as well as rare dis­eases to Voy­ager Ther­a­peu­tics $VY­GR, where he’ll be CMO. His work at Roche in­volved cre­at­ing new gene ther­a­py pro­grams for a list of rare dis­eases, in­clud­ing spinal mus­cu­lar at­ro­phy as well as Hunt­ing­ton’s dis­ease. And he’ll put that ex­per­tise to work now for Voy­ager, which has been strug­gling with a lead pro­gram on Parkin­son’s.

Terns Phar­ma­ceu­ti­cals has re­cruit­ed Gilead vet Erin Quirk to re­al­ize its am­bi­tious clin­i­cal plans in NASH. As CMO, Quirk will co­or­di­nate a dis­cov­ery team in San Ma­teo, CA, where she is based, and a small de­vel­op­ment group in Chi­na. The hope is this mod­el could as­sem­ble a pipeline and ef­fi­cient­ly de­vel­op new drugs pri­mar­i­ly for the Chi­nese mar­ket, with op­por­tu­ni­ties to reach US pa­tients si­mul­ta­ne­ous­ly. Most re­cent­ly a VP of clin­i­cal re­search at Gilead, Quirk has al­so run clin­i­cal pro­grams for Mer­ck.

→ Hav­ing steered an an­tibi­ot­ic through to an ap­proval at In­smed, CMO Paul Streck is mov­ing on­to the next project at Alder Bio­Phar­ma­ceu­ti­cals $AL­DR. He will have the same role but work on a much dif­fer­ent drug: eptinezum­ab, a CGRP mi­graine drug look­ing to find a place among big ri­vals, with a sub­mis­sion slat­ed for this quar­ter. Streck, who ran clin­i­cal pro­grams across a range of ther­a­peu­tic ar­eas while at Glax­o­SmithK­line and Shire, suc­ceeds in­ter­im CMO Er­ic Carter.

→ De­spite a de­layed re­view for its peanut al­ler­gy drug — which Aim­mune $AIMT has at­trib­uted to the FDA shut­down, though Com­mis­sion­er Scott Got­tlieb seems to sug­gest oth­er­wise — the com­pa­ny is go­ing ahead with the ap­point­ment of a chief com­mer­cial of­fi­cer. An­drew Ox­to­by jumps from Eli Lil­ly, where he was in charge of the in­sulin busi­ness af­ter stints in the on­col­o­gy unit.

→ As Tri­ci­da $TC­DA hus­tles its late-stage chron­ic kid­ney dis­ease drug to the FDA, it’s brought in Su­san­nah Cantrell as chief com­mer­cial of­fi­cer. A Big Phar­ma vet with stints at Glax­o­SmithK­line and Roche/Genen­tech, Cantrell most re­cent­ly man­aged Gilead’s on­col­o­gy busi­ness.

→ Con­ju­gate vac­cine de­vel­op­er SutroVax has named Elaine Sun its chief strat­e­gy of­fi­cer in ad­di­tion to her cur­rent role as CFO, with re­spon­si­bil­i­ties for fi­nan­cial, cor­po­rate de­vel­op­ment and strat­e­gy func­tions. Sun, who first joined the com­pa­ny in 2017, has a back­ground in fi­nan­cial and busi­ness ad­vi­so­ry with ex­pe­ri­ence lead­ing the health­care groups at Ever­core and Mer­rill Lynch. Mean­while, Jane Wright-Mitchell has been hired as gen­er­al coun­sel.

Richard Christo­pher is the new CFO at In­Vi­vo Ther­a­peu­tics, a biotech found­ed on lab work done by MIT’s Bob Langer and Joseph Va­can­ti to treat spinal cord in­jury.

→ Back in busi­ness to roll out its AD­HD drug af­ter a spell in lim­no, Iron­shore Phar­ma­ceu­ti­cals has tapped Mer­ck vet Lewis War­ring­ton to sup­port the com­mer­cial­iza­tion as VP and head of med­ical af­fairs.

Pe­ter Van Vlas­se­laer is stack­ing up his board ap­point­ments af­ter sell­ing AR­MO Bio­sciences to Eli Lil­ly. He’s tak­ing the chair­man seat at As­ceneu­ron, a Mer­ck spin­off de­vel­op­ing tau mod­u­la­tors for Alzheimer’s and oth­er neu­rode­gen­er­a­tive dis­eases.

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 with any issues.

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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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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 and UBS 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.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

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.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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