Jeffrey Bluestone, Sonoma co-founder and CEO (Tessa Therapeutics via YouTube)

Jef­frey Blue­stone re­cruits a trio of bio­phar­ma vets to the start­up team at Sono­ma — while adding $30M to the launch round

Jef­frey Blue­stone’s start­up in the Bay Area just added a pack­et of ven­ture mon­ey to its cash re­serves. But more im­por­tant­ly, the ex-chief of the Park­er In­sti­tute for Can­cer Im­munother­a­py re­cruit­ed sev­er­al more ex­pe­ri­enced vets to the ex­ec­u­tive team that will dri­ve new drugs to con­quer au­toim­mune dis­eases like di­a­betes.

On the mon­ey side, Sono­ma Ther­a­peu­tics to­day an­nounced that its syn­di­cate came up with an ex­tra $30 mil­lion for the launch round, bring­ing the to­tal to $70 mil­lion. The cash came from a broad group of in­vestors, led by Rick Klaus­ner’s Lyell and ARCH. Here’s the rest of the crew: 8VC, Life­Force Cap­i­tal, Lil­ly Asia Ven­tures Bio­sciences, Oc­ta­gon Cap­i­tal, Alexan­dria Ven­ture In­vest­ments, the JDRF T1D Fund and ad­di­tion­al undis­closed in­vestors.

That will help fund a team that now in­cludes:

— Leonard Drag­one, the new chief med­ical of­fi­cer. Drag­one is com­ing in from J&J, where he was VP for ear­ly clin­i­cal de­vel­op­ment in in­fec­tious dis­eases. Be­fore that, he had been the ther­a­peu­tic area lead for au­toim­mu­ni­ty, in­flam­ma­tion and oph­thal­mol­o­gy at Mer­ck and ear­li­er com­plet­ed a stint at Genen­tech.

— Se­jal Hall joined the com­pa­ny from Au­dentes, which was re­cent­ly bought out by Astel­las. She steps in as VP, pro­gram, port­fo­lio and al­liance man­age­ment, a role she held ear­li­er at De­nali.

— Ab­b­Vie vet­er­an Su­san Lacy is al­so join­ing the team as head of dis­cov­ery. She worked at the phar­ma gi­ant for the past 20 years.

Blue­stone left the helm of PI­CI and his post at UC San Fran­cis­co to start a biotech that will fo­cus on Tregs in halt­ing au­toim­mune as­saults. Now, in­stead of dri­ving im­mune re­spons­es to van­quish can­cer cells, he’ll be hit­ting the brakes to stop dis­eases like di­a­betes.

Blue­stone’s promi­nence in the West Coast biotech scene has earned some high-pro­file sup­port­ers, in­clud­ing Klaus­ner, the ex­ec­u­tive chair­man at Lyell who al­so chairs the board at Sono­ma.

And he’s aim­ing high. In a re­cent in­ter­view, he told me:

We’ll end up with a cheap­er ther­a­py on­ly hav­ing to do things once, hope­ful­ly, be­cause it’s built on the plat­form of what evo­lu­tion has al­ready cre­at­ed: reg­u­la­to­ry cells as brakes in the im­mune sys­tem.

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?

Image: Shutterstock

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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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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Emmanuel Hanon (Viome)

Glax­o­SmithK­line’s head of vac­cine R&D is jump­ing to a well­ness com­pa­ny con­cen­trat­ing on the mi­cro­bio­me as re­ports of an ex­o­dus start to spread

Back in the fall of 2019, GlaxoSmithKline vaccine R&D chief Emmanuel Hanon had plenty of good things to say about a wellness company called Viome and CEO Naveen Jain. He was particularly interested in Viome’s technology for analyzing the gut microbiome and how that could intersect with new vaccine research.

Today, Hanon is jumping ship to join his collaborator as R&D chief as reports circulate of an exodus at GSK’s big vaccine group.

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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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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.

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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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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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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