Fresh out of the blue­bird bio on­col­o­gy split, Joanne Smith-Far­rell flies the coop to Be Bio and its B cell plat­form

Stung by set­backs and a stag­nant pipeline, blue­bird bio, the once-dar­ling of gene ther­a­py biotech, made the tough call to sev­er its rare dis­ease and on­col­o­gy units ear­li­er this year. One of the busi­ness leads on blue­bird’s on­col­o­gy side has now popped up at a new­ly launched B cell play­er — and she’s tak­ing her for­mer em­ploy­er’s “pi­o­neer­ing” ex­am­ple to heart.

Joanne Smith-Far­rell

Joanne Smith-Far­rell, for­mer­ly blue­bird’s chief op­er­at­ing of­fi­cer and head of the on­col­o­gy busi­ness unit, is now CEO at Be Bio­phar­ma, an ear­ly-stage biotech tar­get­ing en­gi­neered B cells for ther­a­peu­tic use. Smith-Far­rell is joined on the team by CSO Rick Mor­gan, an­oth­er blue­bird vet who was most re­cent­ly se­nior VP of im­muno­genet­ics at Ed­i­tas.

Tak­ing the lead at Be Bio rep­re­sents a step in­to the CEO seat for the first time for Smith-Far­rell, who cut her teeth study­ing bio­med­ical en­gi­neer­ing in Bob Langer’s famed lab at MIT be­fore mak­ing the jump to in­dus­try. She’s both a Pfiz­er and Mer­ck vet­er­an and joined blue­bird in March 2017 to head the on­col­o­gy fran­chise. The most ad­vanced can­di­date there is mul­ti­ple myelo­ma can­di­date ide-cel, a Bris­tol My­ers Squibb-part­nered CAR-T that faces an FDA re­view this year.

In her telling, Smith-Far­rell was “at the heart” of de­lib­er­a­tions over spin­ning off blue­bird’s on­col­o­gy unit in­to an as-yet-un­named busi­ness led by CEO Nick Leschly. Mean­while, the re­main­ing gene ther­a­py as­sets, in­clud­ing gene ther­a­py Zyn­te­glo and can­di­dates in be­ta tha­lassemia and sick­le cell dis­ease, will keep the blue­bird moniker. De­spite the tec­ton­ic shift in the busi­ness mod­el af­ter a dis­ap­point­ing few years, Smith-Far­rell said the spin­off “was not the rea­son” she chose to de­part.

“It was very op­por­tunis­tic,” Smith-Far­rell told End­points News. “This (op­por­tu­ni­ty) came across, and it’s very hard to see some­thing with this kind of po­ten­tial for im­pact. It’s rare. The op­por­tu­ni­ty to come out and be a CEO … feels like a great next step.”

Mean­while, Smith-Far­rell looked back at the blue­bird’s de­ci­sion to split and called it “the right de­ci­sion” at the time.

“I have a lot of con­fi­dence in the blue­bird team be­ing able to do what they need to do go­ing for­ward,” she said.

As part of a rapid ex­pan­sion tak­ing Be Bio from just two em­ploy­ees at the end of 2020 to about 20 cur­rent­ly on staff, Smith-Far­rell said her first or­ders of busi­ness are build­ing a team that can mod­el the sort of “pi­o­neer­ing” work she be­came fa­mil­iar with at blue­bird.

Rick Mor­gan

Mean­while, Mor­gan will take over a B cell ther­a­peu­tic plat­form with a lot of promise but not much to show so ear­ly in­to launch. His first fo­cus, he said, will al­so be re­fin­ing the vi­sion for the plat­form’s po­ten­tial and build­ing a team that can suc­cess­ful­ly scale the pipeline.

“With the un­der­ly­ing tech­nol­o­gy, where do you point the ap­pli­ca­tions?” he said. “We’re not there yet in terms of say­ing what the first in­di­ca­tions will be, but be­cause the plat­form lends it­self to di­verse in­di­ca­tions, we will build a pipeline that has some breadth to it and a lit­tle more ver­sa­til­i­ty than you would see at oth­er cell ther­a­py com­pa­nies.”

Be Bio launched back in Oc­to­ber with a $52 mil­lion de­but round co-led by At­las Ven­tures and RA Cap­i­tal Man­age­ment. The biotech hopes to re-en­gi­neer B cells as a nov­el ther­a­peu­tic modal­i­ty that can skip past the se­vere side ef­fects of T cell and NK cell ther­a­pies and can al­so be pro­duced al­lo­gene­ical­ly.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Alan List, new Precision BioSciences CMO, in 2019 (Diane Bondareff/AP Images for Moffitt Cancer Center)

Eli Lil­ly-part­nered biotech taps star in­ves­ti­ga­tor Alan List as CMO — a year af­ter he re­signed from Mof­fitt over Chi­na scan­dal

After laying low for more than a year following a scandal that led to his ouster, former Moffitt Cancer Center CEO Alan List has emerged in the frontlines of biotech.

An expert in hematology and oncology drug development known as a lead investigator for Celgene’s blockbuster Revlimid, List is swapping “clinical trials consultant” for the chief medical officer title at Precision BioSciences — a Eli Lilly-partnered biotech boasting a new gene editing approach to cell and gene correction therapies.