Ivana Magovčević-Liebisch, Vigil CEO (file photo)

Vig­il Neu­ro­science launch­es with a $50M Se­ries A and two for­mer Am­gen neu­ro­science can­di­dates

Af­ter more than 20 years in the in­dus­try, Ivana Magov­če­vić-Liebisch had done it all — ex­cept build a com­pa­ny from scratch. Then Bruce Booth at At­las Ven­ture men­tioned a cou­ple of TREM2 as­sets he was try­ing to snag from Am­gen’s old neu­ro­science pipeline.

Bruce Booth

“I came in to help them bring the as­sets in,” Magov­če­vić-Liebisch said. “As we start­ed work­ing to­geth­er, it be­came a clear fit… It kind of checked all the box­es.”

On Tues­day, they launched mi­croglia-fo­cused Vig­il Neu­ro­science with a $50 mil­lion Se­ries A, 13 staffers and their sights set on the clin­ic. The round, co-led by At­las and North­pond Ven­tures, should be enough to see the start­up’s lead mon­o­clon­al an­ti­body TREM2 ag­o­nist through Phase I, Magov­če­vić-Liebisch said. The oth­er can­di­date, a small mol­e­cule TREM2 ag­o­nist, is on its way to an IND.

Hat­teras Ven­ture Part­ners and Alexan­dria Ven­ture In­vest­ments al­so chipped in on the fi­nanc­ing.

While Vig­il is keep­ing qui­et about the fi­nan­cial terms of its Am­gen deal, Magov­če­vić-Liebisch said Am­gen is a share­hold­er and re­mains “very in­ter­est­ed in these tar­gets.” The CEO didn’t give much in­for­ma­tion on the first in­di­ca­tion, on­ly re­veal­ing that it’s a “rare mi­crogliopa­thy.”

The biotech got its name from the “vig­i­lance of mi­croglia,” Magov­če­vić-Liebisch said. “They are the ones that kind of watch over the health and well-be­ing of the brain and pro­tect against the process­es that lead to neu­rode­gen­er­a­tion.”

Mar­co Colon­na

Many foun­da­tion­al dis­cov­er­ies re­gard­ing TREM’s role in the cen­tral ner­vous sys­tem trace back to Mar­co Colon­na’s lab at the Wash­ing­ton Uni­ver­si­ty School of Med­i­cine. TREM2 is a trig­ger­ing re­cep­tor on Myeloid Cells 2, which me­di­ates mi­croglia re­sponse to en­vi­ron­men­tal sig­nals. It serves as a dam­age sen­sor, said Colon­na, who’s now on Vig­il’s sci­en­tif­ic ad­vi­so­ry board.

“We have iden­ti­fied mul­ti­ple neu­rode­gen­er­a­tive dis­eases with clear ev­i­dence of ge­net­i­cal­ly linked mi­croglial dys­func­tion im­pact­ing small and large pa­tient pop­u­la­tions. Most of these dis­eases are se­vere with lim­it­ed to no treat­ment op­tions,” Booth said in a state­ment.

“We have built Vig­il to trans­late these ex­cit­ing break­throughs in ba­sic sci­ence and hu­man ge­net­ics of mi­croglia in­to pre­ci­sion-based ther­a­pies that will help pa­tients suf­fer­ing from these dev­as­tat­ing dis­eases,” he con­tin­ued.

Over the last sev­er­al years, in­dus­try lead­ers have left or trimmed back pro­grams in neu­ro­science. And last year, Am­gen joined the club. The com­pa­ny cut a ma­jor­i­ty of its neu­ro­science re­search, in­clud­ing the as­sets ac­quired by Vig­il.

“We’re feel­ing ex­cit­ed about the po­ten­tial that mi­croglia bi­ol­o­gy has in bring­ing new in­no­v­a­tive treat­ments to pa­tients in need. Our vi­sion is a bet­ter to­mor­row for peo­ple with neu­rode­gen­er­a­tive dis­eases,”  Magov­če­vić-Liebisch said.

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.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

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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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

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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