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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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