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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Diem Nguyen tapped to lead 'point of in­flec­tion' at Xalud Ther­a­peu­tics; Di­ana Es­co­lar dances her way to Avro­bio CMO

Diem Nguyen considers herself a “point of inflection seer.”

Helping businesses strategize and scale up is “where my sweet spot is,” the Pfizer veteran said. So when she was tapped to take the helm at gene therapy-focused Xalud Therapeutics, she knew it would be a great fit.

Xalud, founded in 2009 and headquartered in New York City, is working on non-viral gene therapies to treat pathologic inflammation. The company’s lead candidate, XT-150, is a locally injectable plasmid DNA gene therapy expressing Interleukin 10 (IL-10) — an upstream modulator for many pro-inflammatory and anti-inflammatory mediators.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.