Roche grabs a re­myeli­na­tion MS drug from Ver­sant as the re­search team spins out in­to a $25M re­gen­er­a­tive med start­up

Near­ly 4 years af­ter Roche agreed to pay the re­search tab for a team of in­ves­ti­ga­tors at Ver­sant Ven­tures’ dis­cov­ery group In­cep­tion Sci­ences to see if they could come up with a vi­able, IND-ready com­pound to take in­to the clin­ic for re­myeli­na­tion work in mul­ti­ple scle­ro­sis, the phar­ma gi­ant has grabbed its star can­di­date. And the team they helped fund is now be­ing spun out in­to a start­up fo­cused on neu­rore­gen­er­a­tion with the bless­ings of Ver­sant and a com­mit­ment of $25 mil­lion to help fund their new, in­de­pen­dent ex­is­tence.

Brad Bol­zon

Not un­usu­al­ly for ear­ly-stage work, we aren’t get­ting the full suite of de­tails on ei­ther the Roche deal teams or the start­up. Ver­sant’s Brad Bol­zon says the phar­ma gi­ant is ready to go in­to the clin­ic, and he sees Ver­sant’s start­up crew at the new­ly cre­at­ed Pipeline Ther­a­peu­tics as an­oth­er sign of the re­birth of the re­gen­er­a­tive med­i­cine field — some­thing they’ve al­ready bet big on with the launch of Bay­er-backed Blue­Rock.

Re­myeli­na­tion in­volves a re­pair to the nerve dam­age that caus­es MS, an at­tempt to re­verse a dev­as­tat­ing dis­ease. That’s a big goal, and a tough tar­get. Bio­gen tried and failed on re­myeli­na­tion in a high-pro­file Phase II with opicinum­ab, or an­ti-Lin­go-1, in 2016. The drug, though, re­mains in Bio­gen’s pipeline.

Clare Oza­wa

Bri­an Stearns and Daniel Lor­rain, who helped lead the dis­cov­ery work with leads from UC San Fran­cis­co, are off to run the R&D group at Pipeline now, as Clare Oza­wa, Ver­sant’s man­ag­ing di­rec­tor, takes the helm. Pipeline is get­ting start­ed with a team of 12 and plans to seek out­come ear­ly al­liances among phar­ma play­ers look­ing to get back in­to re­gen­er­a­tive med­i­cine af­ter a long ab­sence.

In an in­ter­view, Stearns tells me that the new com­pa­ny plans to re­main a “bit cagey” about its pipeline right now, but not­ed that synap­tic de­fi­cien­cies will be one area of neu­rore­gen­er­a­tion it plans to fo­cus on.

“This is ex­act­ly what the dis­cov­ery en­gines were de­signed to do,” says Bol­zon, “be an ear­ly mover in­to a new field like re­myeli­na­tion.” These new op­er­a­tions can part­ner or go it alone, rais­ing more mon­ey — just like we saw a few days ago with Ver­sant spin­out Tem­pest’s $70 mil­lion round.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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