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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.