Diana Brainard, incoming AlloVir CEO

One of the mas­ter­minds be­hind remde­sivir, Gilead­'s Di­ana Brainard jumps ship to an­tivi­ral T cell play­er AlloVir

As one of the star­tups tapped to join David Hal­lal’s dis­rup­tive man­u­fac­tur­ing out­fit El­e­vate­Bio in the Boston area, AlloVir has built an ag­gres­sive clin­i­cal pro­gram for its virus-spe­cif­ic T cells. Now, the biotech is tap­ping as chief a Gilead vet­er­an with her own ex­pe­ri­ence rac­ing a high­ly tout­ed an­tivi­ral to mar­ket.

Di­ana Brainard, one of the key dri­vers be­hind Gilead’s push to se­cure an emer­gency use au­tho­riza­tion for an­tivi­ral remde­sivir in Covid-19, will take over as CEO of the up­start vi­ral play­er on May 17.

A long­time Gilead vet­er­an head­ing the drug­mak­er’s vi­ral ther­a­peu­tics area, Brainard has served on AlloVir’s board since and as an in­de­pen­dent di­rec­tor since April 2019. Her el­e­va­tion to AlloVir’s top spot comes as Hal­lal moves over to the ex­ec­u­tive chair­man role.

Gilead was one of AlloVir’s ear­li­est in­vestors af­ter Hal­lal tapped the biotech for its next-man­u­fac­tur­ing “base­camp” at El­e­vate­Bio in ear­ly 2019. The com­pa­ny, pre­vi­ous­ly known as Vira­Cyte and based in Hous­ton, scored a $120 mil­lion fundrais­ing round at the time to chase its al­lo­gene­ic virus-spe­cif­ic T cells.

Brainard will take the helm as AlloVir nav­i­gates eight sep­a­rate clin­i­cal tri­als, part of an R&D pro­gram Brainard said has “blown up” over the course of the past year. The most ad­vanced of those can­di­dates, a mul­ti-spe­cif­ic T cell ther­a­py dubbed Vi­ra­lym-M, tar­gets five vi­ral pathogens and is cur­rent­ly in a Phase III piv­otal study against virus-as­so­ci­at­ed he­m­or­rhag­ic-cys­ti­tis. The can­di­date is be­ing test­ed in cy­tomegalovirus, BK virus, ade­n­ovirus, Ep­stein-Barr and hu­man her­pesvirus-6.

Jump­ing in­to the CEO role is a big leap for Brainard on two fronts: She’s nev­er held the top post, and, as a vet­er­an of Gilead and Mer­ck, she’s nev­er been hand­ed the keys to a nim­ble biotech.

“To be hon­est, I’m ter­ri­fied. It’s a brand new thing for me — but those but­ter­flies are part of the ap­peal of the job,” she told me. “I think that’s part of the dri­ver for me is miss­ing that, miss­ing that sense of ‘wow, I’m re­al­ly stretch­ing my­self.'”

With a cou­ple months be­fore she starts, Brainard has leaned on her A-list cir­cle of peers for guid­ance, in­clud­ing Nor­bert Bischof­berg­er, the for­mer Gilead R&D head who jumped ship to steer Kro­nos Bio, and Robin Wash­ing­ton, for­mer­ly Gilead CFO, now a board mem­ber at Google’s Al­pha­bet. Mean­while, she hopes to mod­el her lead­er­ship style off Gilead head Daniel O’Day and in­cum­bent leader Hal­lal and his ex­pe­ri­ence at Alex­ion.

“There will be con­ti­nu­ity, and we have a great part­ner­ship,” Brainard said of Hal­lal. “We have com­ple­men­tary back­ground and skills, and that will be ter­rif­ic.”

Hal­lal will be watch­ing from his ex­ec­u­tive chair seat as well as steer­ing the biotech that made this all hap­pen: El­e­vate­Bio, which has been on a rapid growth clip in its own right. Ear­li­er this month, the start­up closed a mas­sive $525 mil­lion Se­ries C it will use to keep build­ing its next-gen start­up en­gine and one-stop-shop cell and gene ther­a­py man­u­fac­tur­ing “ecosys­tem.” AlloVir is one of three star­tups on board at El­e­vate’s Cam­bridge, MA site, and Hal­lal re­cent­ly said the plan is to add a new com­pa­ny each year mov­ing for­ward.

The move up the cor­po­rate lad­der al­so struck a per­son­al tone for Brainard, who is leav­ing the Bay Area to re­turn to Boston, where she spent near­ly 10 years at Mass Gen­er­al and met her hus­band, the ven­ture cap­i­tal­ist David Shay­witz. Mak­ing the move with three teenage daugh­ters will be no easy task, she said, but the new land­ing spot feels like a “home­com­ing.”

AlloVir will im­me­di­ate­ly lean on Brainard’s lengthy ex­pe­ri­ence at Gilead build­ing and run­ning the he­pati­tis C port­fo­lio in Fos­ter City as well as her clos­ing act in bring­ing remde­sivir to mar­ket. In a con­ver­sa­tion with Fier­cePhar­ma in Oc­to­ber, Brainard dis­cussed her team’s role in re­pur­pos­ing remde­sivir, an an­tivi­ral once de­vel­oped for Ebo­la, in record time to treat hos­pi­tal­ized Covid-19 pa­tients. De­spite some mixed re­sults in ben­e­fit­ting Covid-19 pa­tients across the treat­ment spec­trum, remde­sivir has emerged as an ear­ly stan­dard-of-care in hos­pi­tal­ized pa­tients. That rapid scale-up didn’t hap­pen with­out some sweat eq­ui­ty.

“There was a chance for us to make a dif­fer­ence, and if we were go­ing to do that, we were go­ing to have to work re­al­ly hard,” she said at the time.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Aptinyx eval­u­ates fu­ture of the com­pa­ny fol­low­ing two failed tri­als, 60% lay­offs

This year has been tough for Aptinyx — two failed trials, a 60% cut in its workforce, and now the company has brought on a firm to help evaluate the future of the company.

The press release noted it’s working with the firm Ladenburg Thalmann as its financial advisor to assist in exploring and evaluating “strategic alternatives” — a process that a growing group of struggling biotechs has embarked on, sometimes ending in a merger, asset sale or wind-down.

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Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

Paul Stoffels, Galapagos CEO (Andrew Harnik/AP Images)

Gala­pa­gos sends some em­ploy­ees — and a re­search unit — off to drug dis­cov­ery CRO as part of re­org

Paul Stoffels has made it clear that he views cutting jobs at Galapagos as difficult but necessary — but he’s getting creative about it.

Galapagos, headquartered in Mechelen, Belgium, has struck an arrangement with French contract research organization NovAliX to transfer its drug discovery and research activities. While NovAliX is based in Strasbourg, it will take over running the site that Galapagos ran in Romainville, France.

CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.