Fred­er­ic Pla en­list­ed as COO at the Park­er In­sti­tute; For­mer Alk­er­mes ex­ec named CMO at Seres Ther­a­peu­tics

Fred­er­ic Pla Park­er In­sti­tute

→ The Park­er In­sti­tute for Can­cer Im­munother­a­py has wel­comed Fred­er­ic Pla aboard as COO. Pri­or to his ap­point­ment, Pla served as COO at Ge­nom­ic Health. Pla has held ap­point­ments at Life Tech­nolo­gies — as VP, cor­po­rate busi­ness de­vel­op­ment — and GE Health­care. He be­gan his ca­reer at the NASA Glenn Re­search Cen­ter. PI­CI, found­ed by bil­lion­aire Sean Park­er, con­tin­ues to search for a new CEO in the wake of Jef­frey Blue­stone’s de­par­ture to launch a new biotech com­pa­ny.

Lisa von Moltke

Lisa von Moltke has stepped in as EVP and CMO at Seres Ther­a­peu­tics, whose SER-109 pro­gram is in Phase III de­vel­op­ment for re­cur­rent C. dif­fi­cile in­fec­tion. She comes to Seres af­ter 5 years at Alk­er­mes, where she most re­cent­ly had been SVP and head of clin­i­cal de­vel­op­ment. She’s al­so been VP, clin­i­cal and ex­plorato­ry phar­ma­col­o­gy at Sanofi and se­nior di­rec­tor of trans­la­tion­al med­i­cine at Take­da.

Af­ter bid­ding adieu to its then-CEO Michael Pehl more than a year ago, along with a sur­prise com­plete re­sponse let­ter from the FDA, Im­munomedics has en­list­ed No­var­tis On­col­o­gy vet Harout Se­mer­jian as CEO. Se­mer­jian’s ap­point­ment comes just in time for him to steer the com­pa­ny to a new PDU­FA date in June. Most re­cent­ly, Se­mer­jian served as EVP, CCO at Ipsen. Dur­ing his time at No­var­tis On­col­o­gy, Se­mer­jian held var­i­ous roles, cul­mi­nat­ing in his last role as SVP, glob­al head of Ri­bo­ci­clib. With his ap­point­ment, Scott Canute will step down from his role as ex­ec­u­tive di­rec­tor and re­sume his role as board mem­ber.

Gade­ta — fo­cused on hema­to­log­i­cal can­cers and sol­id tu­mors — has tapped Mar­co Lon­dei as CEO. Lon­dei’s ap­point­ment comes at a time in which the com­pa­ny is tran­si­tion­ing from a pre­clin­i­cal stage com­pa­ny to a clin­i­cal stage com­pa­ny. Lon­dei hops aboard af­ter a stint as CMO and chief de­vel­op­ment of­fi­cer of Anap­tys­Bio. In ad­di­tion, Lon­dei held posts at No­var­tis and Bris­tol My­ers Squibb.

Gail McIn­tyre has stepped up as CEO of Ar­a­vive af­ter the res­ig­na­tion of Rekha Hem­ra­jani. McIn­tyre joined Ar­a­vive in 2016 and most re­cent­ly served as the com­pa­ny’s CSO. In ad­di­tion, the board ap­point­ed the founder of Es­hel­man Ven­ture Fred Es­hel­man as chair­man of the board. Jay Shep­ard, Srini­vas Akkara­ju and Robert Hoff­man have all re­signed from the board of di­rec­tors.

Harout Se­mer­jian

→ British bank Bar­clays has ap­point­ed JP Mor­gan vet Khaled Habayeb as man­ag­ing di­rec­tor in health­care eq­ui­ty cap­i­tal mar­kets (ECM). Habayeb will be based in New York. Habayeb joins the com­pa­ny from Deutsche Bank and pre­vi­ous­ly served as man­ag­ing di­rec­tor and head of health­care ECM at UBS.

→ Changes at Ar­ix Bio­science have been plen­ti­ful re­cent­ly. In March, it was Rober­to Ia­cone join­ing Ar­ix; in April, they’re do­ing a big­ger shuf­fle. Co-founder Joe An­der­son will step down ef­fec­tive im­me­di­ate­ly, while Naseem Amin, cur­rent­ly non-ex­ec­u­tive di­rec­tor, will step in as ex­ec­u­tive chair­man. The board of di­rec­tors al­so will have a new look as Jonathan Pea­cock, co-founder and chair­man, and Art Pap­pas, non-ex­ec­u­tive di­rec­tor, will ex­it the board at the Lon­don biotech’s An­nu­al Gen­er­al Meet­ing.

→ Fol­low­ing up its ad­di­tion of Pe­ter Linde as CMO, Mor­phic Ther­a­peu­tic has named Marc Schegerin CFO and COO. Schegerin heads to the Waltham, Mass­a­chu­setts biotech from Ar­Qule, where he was CFO, trea­sur­er and head of strat­e­gy & com­mu­ni­ca­tions be­fore Mer­ck ac­quired the on­col­o­gy-fo­cused drug de­vel­op­er for $2.7 bil­lion. Else­where in the in­dus­try, he pre­vi­ous­ly held di­rec­tor­ships at Bio­gen and Sage.

Marc Schegerin Mor­phic

→ Swiss-based Polyneu­ron Phar­ma­ceu­ti­cals, which reeled in $22.6 mil­lion in Se­ries A fi­nanc­ing last year, has ap­point­ed De­bra Bark­er as CMO. Be­fore join­ing Polyneu­ron, which fo­cus­es on au­toim­mune dis­eases of the ner­vous sys­tem, Bark­er was chief med­ical and de­vel­op­ment of­fi­cer of Polyphor. She al­so had a num­ber of roles at No­var­tis, no­tably as glob­al pro­gram head, on­col­o­gy, as well as po­si­tions at GSK and Roche.

Cal­lid­i­tas Ther­a­peu­tics, known for its de­vel­op­ment of Ne­fe­con to po­ten­tial­ly treat the in­flam­ma­to­ry re­nal dis­ease IgA nephropa­thy (IgAN), has a new CMO. Richard Philip­son has al­most a quar­ter-cen­tu­ry of ex­pe­ri­ence in the in­dus­try and tran­si­tions from his CMO role at Trizell to the Stock­holm-based phar­ma. Philip­son’s pre­vi­ous stops in­clude Take­da as ex­ec­u­tive med­ical di­rec­tor and Glax­o­SmithK­line, where he round­ed out his near­ly 16-year tenure as dis­ease area head and act­ing CMO for the rare dis­eases unit.

→ Hous­ton-based Ar­a­vive is un­der­go­ing a shake­up at the top. Out goes CEO Rekha Hem­ra­jani, who’s be­ing re­placed at the helm by CSO Gail McIn­tyre. Jay Shep­ard, Srini­vas Akkara­ju and Robert Hoff­man have re­signed from the board of di­rec­tors while Fred Es­hel­man was named chair­man of the board.

De­bra Bark­er

Tim Adams has an­nounced his res­ig­na­tion as CFO of Ob­sE­va SA, a Swiss bio­phar­ma cen­tered on women’s re­pro­duc­tive health. He’ll be re­placed by Fa­bi­en de Ladon­champs, Ob­sE­va’s VP, cor­po­rate af­fairs & fi­nance. Adams seeks new op­por­tu­ni­ties af­ter be­ing CFO for three years.

Lara Hashimo­to has tak­en over as CMO at SOPHiA GE­NET­ICS, join­ing the da­ta-dri­ven med­i­cine biotech ef­fec­tive April 1. Pri­or to her ar­rival, Hashimo­to had been chief com­mer­cial of­fi­cer at Roche Se­quenc­ing So­lu­tions, and be­fore that, she was in charge of IVD (in vit­ro di­ag­nos­tic) de­vel­op­ment and com­mer­cial­iza­tion at Roche Di­ag­nos­tics.

In­cyte vet Richard Levy has leapt on­to the board of di­rec­tors at Con­stel­la­tion Phar­ma­ceu­ti­cals. Levy served as EVP and chief drug de­vel­op­ment and med­ical of­fi­cer at In­cyte and pre­vi­ous­ly served at Cel­gene and San­doz/No­var­tis.

Kevin O’Dono­van H.E.L

→ Chad Mirkin is step­ping down as chair­man of the board of di­rec­tors at Al­ler­gan-part­nered gene ex­pres­sion ex­pert Ex­i­cure. Tim­o­thy Wal­bert, CEO of Hori­zon Ther­a­peu­tics, has been named as his suc­ces­sor. Mirkin will re­main on the board.

Glob­al de­vel­op­er and man­u­fac­tur­er of lab­o­ra­to­ry tools H.E.L Group has wel­comed Kevin O’Dono­van as chair of the com­pa­ny’s board of di­rec­tors, tak­ing over from in­ter­im chair Jon An­drew. O’Dono­van was pre­vi­ous­ly the founder of Hy­baid, a mol­e­c­u­lar bi­ol­o­gy in­stru­men­ta­tion com­pa­ny.

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

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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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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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.