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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 billion-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.