Google’s Ver­i­ly and Glax­o­SmithK­line hatch a $713M plan to spark a biorev­o­lu­tion

Glob­al phar­ma gi­ant Glax­o­SmithK­line is team­ing up with Google’s life sci­ences ven­ture Ver­i­ly, chan­nel­ing its four-year ef­fort to cre­ate new nan­otech-based bio­elec­tron­ic ther­a­peu­tics in­to a start­up called Gal­vani Bio­elec­tron­ics, with joint plans to in­vest $713 mil­lion in­to the ven­ture over the next sev­en years.

GSK’s Chair­man of Vac­cines, Mon­cef Slaoui

GSK’s Mon­cef Slaoui has billed this ef­fort as a rev­o­lu­tion­ary at­tempt to break out of the tra­di­tion­al mode of ther­a­peu­tic de­vel­op­ment, re­think­ing the sci­ence and tech­nol­o­gy of drug R&D to cre­ate a com­plete­ly new de­vel­op­ment field in elec­tro­ceu­ti­cals, which will now be fo­cused on in­flam­ma­to­ry, meta­bol­ic and en­docrine dis­or­ders, in­clud­ing type 2 di­a­betes. And now Ver­i­ly Life Sci­ences, for­mer­ly Google Life Sci­ences which op­er­ates un­der the new Al­pha­bet ban­ner, is mak­ing a big biotech bet that it can live up to its mis­sion to trans­form med­i­cine by part­ner­ing with GSK.

Gal­vani will be based in the UK biotech hub in Steve­nage, with an­oth­er re­search cen­ter at Ver­i­ly’s cam­pus in South San Fran­cis­co. They’ll get start­ed with a staff of 30 and GSK’s start­up en­deav­ors to date. Glaxo will own 55% of the com­pa­ny, with Ver­i­ly tak­ing the rest. Slaoui has been tapped to chair the new com­pa­ny and shep­herd one of his fa­vorite projects.

They’re not think­ing small. And they aren’t stop­ping at 30. A spokesper­son for Ver­i­ly of­fered End­points this in­sight on the new jobs that are ex­pect­ed to be cre­at­ed.

“In ad­di­tion to the 30 ini­tial FTEs, Gal­vani will fund and in­te­grate – both through strate­gic col­lab­o­ra­tions with the two par­ent com­pa­nies and with oth­ers – a broad range of oth­er col­lab­o­ra­tions in acad­e­mia and with R&D com­pa­nies, build­ing on the suc­cess­ful mod­el we’ve de­vel­oped in GSK Bio­elec­tron­ics over three years. It will in­volve ap­prox­i­mate­ly 100 FTEs (full time equiv­a­lents) at Ver­i­ly and about 100 FTEs across the spec­trum of oth­er part­ner­ships. By ef­fec­tive­ly ty­ing such a net­work of ex­perts to­geth­er, we be­lieve we can rapid­ly ac­cel­er­ate the de­vel­op­ment of bio­elec­tron­ic med­i­cines.”

“This is an am­bi­tious col­lab­o­ra­tion al­low­ing GSK and Ver­i­ly to com­bine forces and have a huge im­pact on an emerg­ing field,” said Ver­i­ly Chief Tech­nol­o­gy Of­fi­cer Bri­an Otis. “Bio­elec­tron­ic med­i­cine is a new area of ther­a­peu­tic ex­plo­ration, and we know that suc­cess will re­quire the con­flu­ence of deep dis­ease bi­ol­o­gy ex­per­tise and new high­ly minia­turised tech­nolo­gies.

Ver­i­ly’s big agen­da is to har­ness new life sci­ence tech­nol­o­gy in search of a mul­ti­tude of new ways to im­prove hu­man health and rev up a longer life with­out the many af­flic­tions that drag peo­ple down the longer they live.

In Glax­o­SmithK­line’s case, they start­ed out with spe­cif­ic dis­eases in mind, look­ing to di­rect nerve stim­u­la­tors that could, for ex­am­ple, in­flu­ence rheuma­toid arthri­tis. The com­pa­ny set up a spe­cial $50 mil­lion fund to help jump­start a small group of biotechs spe­cial­iz­ing in elec­tro­ceu­ti­cals. A $1 mil­lion sci­ence prize was set up to help gin up some ex­cite­ment. And col­lab­o­ra­tions fol­lowed with oth­er com­pa­nies in the field. More part­ner­ing is ex­pect­ed as the new com­pa­ny gets up and run­ning.

GSK said ear­li­er this year that it plans to be in the clin­ic with its first pro­grams in 2017.

A cou­ple of years ago, GSK’s Slaoui, who now runs the vac­cines group for GSK, had this to say in an in­ter­view with The Chi­na Post:

(W)e re­al­ized that when we use chem­i­cal struc­ture or re­com­bi­nant pro­tein as a med­i­cine, what we use in fact are the struc­tures of these med­i­cines to in­ter­act with the struc­ture of a re­cep­tor or pro­tein in our body … Our body us­es struc­ture to com­mu­ni­cate with bi­ol­o­gy, but it al­so us­es elec­tri­cal im­puls­es which go through our nerves. So we asked the ques­tion: ‘Can we use elec­tri­cal im­puls­es to mod­i­fy the way or­gans func­tion?’”

“We have ev­i­dence that our body can read elec­tri­cal mes­sages we give it. This has cre­at­ed a new vi­sion to de­sign nano-tech­no­log­i­cal de­vices that will be able to read the elec­tri­cal sig­nals that are trans­mit­ting in our nerves, and hope­ful­ly (we will) be able to iden­ti­fy ab­nor­mal sig­nals … and cor­rect it by giv­ing it a dif­fer­ent sig­nal.”

To test that con­cept, in­ves­ti­ga­tors found that the right elec­tron­ic puls­es could spur the pan­creas to pro­duce in­sulin, to treat di­a­betes. And an­oth­er pre­clin­i­cal test worked on blood pres­sure.

Cre­at­ing a new modal­i­ty for ther­a­peu­tic de­vel­op­ment, though, presents huge and ex­pen­sive hur­dles, es­pe­cial­ly when you’re talk­ing about mass ail­ments like di­a­betes and heart dis­ease. Reg­u­la­tors put up high bars on safe­ty that most biotechs could nev­er hope to clear with a small, lim­it­ed re­search bud­get.

Ver­i­ly and Google, though, are a whole dif­fer­ent mat­ter.

Google has the kind of deep pock­ets that most com­pa­ny ex­ecs can on­ly dream about. That’s al­so help­ing fund Cal­i­co, which has stealth­ily moved ahead on a num­ber of pro­grams aimed at healthy longevi­ty.

STAT has been tak­ing some round­house swings at Ver­i­ly, claim­ing that its top de­vel­op­ment pro­grams are more sci­ence fic­tion than po­ten­tial near-term tools for the life sci­ences mar­ket.

GSK doesn’t ap­pear to be both­ered by that, though.

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?

Voting in the 2020 election (AP Images)

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We oppose all attempts to introduce laws that reduce the rights of US citizens to vote or that restrict them from exercising that right. The right to vote is fundamental to democracy. States that have enacted, or are proposing to enact, legislation to restrict voting are undermining our democracy and posing a threat to our nation. As leaders of the life sciences industry, we stand for what we believe is right for our country, our enterprises, our employees and those who benefit from our work. We join the first groups of business leaders who have challenged these laws and will continue to make our collective voices heard on this matter.

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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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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Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

Anand Shah (FDA)

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.

Stéphane Bancel, Moderna CEO (Jeff Rumans)

'Learned a lot last year': Af­ter Covid-19 suc­cess, Mod­er­na's Stéphane Ban­cel plans to give rest of pipeline a big push

A year ago, Stéphane Bancel would have described Moderna as cautious — walking step-by-step to investigate whether mRNA vaccines could prevent a host of viruses. Then the pandemic hit, and the Cambridge, MA-based biotech got a multibillion-dollar windfall to produce the world’s second-ever authorized mRNA vaccine in a matter of months.

What’s next? Bancel is planning a big acceleration and expansion of the rest of the pipeline, including the company’s Phase III-ready candidate for cytomegalovirus (CMV), which was the lead program before Covid-19 came around.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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