GSK vac­cine chief heads for AIDS vac­cine ini­tia­tive; Pfiz­er en­lists Sue Desmond-Hell­mann to its board of di­rec­tors

Rip Bal­lou

Rip Bal­lou, who un­til very re­cent­ly led vac­cine re­search and de­vel­op­ment at Glax­o­SmithK­line, is join­ing the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive (IAVI) to lead its US­AID-fund­ed AD­VANCE pro­gram. The pro­gram us­es a net­work of re­searchers and in­sti­tu­tions in Africa to help de­vel­op a vac­cine for HIV. Bal­lou had worked at GSK since 2010 and has led glob­al vac­cine R&D since 2015. Pri­or to that he held posts at the Bill & Melin­da Gates Foun­da­tion, a dif­fer­ent post at GSK, Med­im­mune, and Wal­ter Reed Army In­sti­tute of Re­search.  IAVI is led by Mark Fein­berg, the for­mer CSO of Mer­ck Vac­cines. 

→ As we re­port­ed yes­ter­day, Sue Desmond-Hell­mann has been elect­ed to Pfiz­er’s board of di­rec­tors along­side a ver­i­ta­ble who’s-who that in­cludes Co­ca-Co­la CEO James Quincey and for­mer FDA chief Scott Got­tlieb. Desmond-Hell­mann was CEO of the Bill & Melin­da Gates Foun­da­tion from 2014 un­til she an­nounced her de­par­ture in De­cem­ber, and be­fore sign­ing on there, was chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co. In her 14-year tenure at Genen­tech, she led the de­vel­op­ment of two land­mark can­cer drugs, Avastin and Her­ceptin.

Lo­cana, which con­cen­trates on an RNA-tar­get­ing gene ther­a­py plat­form, has ap­point­ed Mic­ah Mack­i­son as its CBO. Mack­i­son leaves As­sem­bly Bio­sciences, where he was SVP, cor­po­rate de­vel­op­ment & strat­e­gy since 2015. He had been at a cor­nu­copia of bio­phar­ma play­ers be­fore As­sem­bly: H. Lund­beck A/S, as head of cor­po­rate strat­e­gy and se­nior di­rec­tor, new ven­tures; Ova­tion Phar­ma­ceu­ti­cals, as di­rec­tor, cor­po­rate de­vel­op­ment and M&A; and fi­nan­cial roles at Eli Lil­ly and Pfiz­er.

Mic­ah Mack­i­son

Jesse Mc­Cool has been pro­mot­ed to CEO of Cy­to­vance Bi­o­log­ics, a CD­MO that de­vel­ops and man­u­fac­tures ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) from both mam­malian cell cul­ture and mi­cro­bial fer­men­ta­tion. He re­places Yan Wang, who is step­ping down from the in­ter­im CEO post. Mc­Cool, who was pre­vi­ous­ly chief tech­nol­o­gy of­fi­cer at Ok­la­homa City-based Cy­to­vance, al­so held po­si­tions at Lon­za and Mas­co­ma Corp.

Owl­stone Med­ical gets a breath of fresh air as it wel­comes Neil Tween as its CFO. Owl­stone is the de­vel­op­er of Breath Biop­sy, which acts as a breath­a­lyz­er to mea­sure chem­i­cals in the breath for ear­ly dis­ease de­tec­tion and pre­ci­sion med­i­cine. Tween jumps to Owl­stone from GW Phar­ma­ceu­ti­cals, where he was VP and group fi­nan­cial con­troller. He al­so spent time at Jagex and De­loitte.

Neil Tween Owl­stone

→ Seneca Bio­phar­ma has made some new changes to its lead­er­ship team. The com­pa­ny wel­comed Matthew Kalnik as pres­i­dent and COO and Dane Saglio as CFO. In ad­di­tion, Seneca pro­mot­ed Thomas Hazel — who joined the com­pa­ny in 1998 — to the new po­si­tion of SVP of re­search and de­vel­op­ment. Kalnik joins the com­pa­ny from An­ti­dote Ther­a­peu­tics and held po­si­tions at Pfiz­er and Nabi Bio­phar­ma­ceu­ti­cals. Pre­vi­ous­ly, Saglio served as the CFO of Re­gen­eRx Bio­phar­ma­ceu­ti­cals.

→ AAV gene ther­a­py de­vel­op­er Stride­Bio has added Mar­itza McIn­tyre to its ex­ec­u­tive team as chief de­vel­op­ment of­fi­cer. McIn­tyre brings more than 20 years of ex­pe­ri­ence in the in­dus­try to the Re­search Tri­an­gle-based biotech. The for­mer pres­i­dent of Ad­vanced Ther­a­pies Part­ners, she al­so held VP po­si­tions at Bam­boo Ther­a­peu­tics and Re­genxbio, and was al­so chief of the gene ther­a­py branch at the FDA.

→ Af­ter a short stint at Gy­ro­scope Ther­a­peu­tics, Lau­ra Ro­ca-Alon­so has made the leap to CBO at the AI drug dis­cov­ery biotech e-ther­a­peu­tics. She was Gy­ro­scope’s di­rec­tor of busi­ness de­vel­op­ment, and be­fore that, she had a num­ber of roles at Si­lence Ther­a­peu­tics, most re­cent­ly as VP, head of cor­po­rate de­vel­op­ment.

Mar­itza McIn­tyre

→ Chi­na-based bi­o­log­ics de­vel­op­er and man­u­fac­tur­er CMAB Bio­phar­ma has tapped Ye Shi as the head of qual­i­ty. Be­fore mak­ing the leap to CMAB, Shi served as deputy gen­er­al man­ag­er and qual­i­ty as­sur­ance di­rec­tor at QILU Phar­ma­ceu­ti­cal. In ad­di­tion, Shi held posts at the PDI Com­pa­ny and Im­munomedics.

Joseph Mc­Crack­en has hopped aboard Lu­mos Phar­ma‘s board of di­rec­tors. Mc­Crack­en brings ex­pe­ri­ence from stints at Roche, Genen­tech and Aven­tis Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny has tapped its CEO Rick Hawkins as chair­man of the board.

→ For­mer pres­i­dent of Pfiz­er On­col­o­gy Gar­ry Nichol­son has joined NextCure‘s board of di­rec­tors. In ad­di­tion, board mem­ber Tim­o­thy Shan­non will be step­ping down from his po­si­tion.

Kim Popovits, for­mer CEO of Ge­nom­ic Health, is join­ing the board of di­rec­tors of se­quenc­ing com­pa­ny 10x Ge­nomics.  Popovits al­so serves on the boards of Kiniksa Phar­ma­ceu­ti­cals and MyoKar­dia.

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.