Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

Vig­il Neu­ro­science hits Wall Street with two ex-Am­gen TREM2 ag­o­nists

Big Phar­ma large­ly aban­doned neu­ro­science over the last sev­er­al years — but the folks at Vig­il Neu­ro­science be­lieve a re­nais­sance is around the cor­ner, and ap­par­ent­ly, so do in­vestors.

The Cam­bridge, MA-based start­up closed a $98 mil­lion IPO on Tues­day, pric­ing 7 mil­lion shares at $14, just be­low an ex­pect­ed $15 to $17 range. Most of that is go­ing to­ward VGL101, an ex-Am­gen TREM2 ag­o­nist in Phase I for a rare neu­rode­gen­er­a­tive dis­ease.

Vig­il launched back in De­cem­ber 2020 with $50 mil­lion in Se­ries A cash and a cou­ple of TREM2 ag­o­nists picked up from Am­gen af­ter it joined Big Phar­ma’s mass ex­o­dus from neu­ro­science. Then back in Au­gust, the biotech reeled in an­oth­er $90 mil­lion from VC in­vestors.

“Am­gen de­cid­ed to ex­it neu­ro. It was a strate­gic de­ci­sion, so it wasn’t any­thing about these as­sets,” CEO Ivana Magov­če­vić-Liebisch ex­plained to End­points News back in Au­gust.

Now the lead can­di­date, VGL101, is in a Phase I study for an in­her­it­ed con­di­tion called adult-on­set leukoen­cephalopa­thy with ax­on­al spher­oids and pig­ment­ed glia (AL­SP), which is char­ac­ter­ized by changes to cer­tain ar­eas of the brain. Pa­tients with AL­SP of­ten ex­pe­ri­ence ear­ly symp­toms like per­son­al­i­ty changes or de­pres­sion, and go on to de­vel­op de­men­tia, dif­fi­cul­ty walk­ing and tremor, among oth­er symp­toms.

Vig­il is fo­cused on treat­ing dis­eases through the mi­croglia, the pri­ma­ry in­nate im­mune ef­fec­tor cells of the cen­tral ner­vous sys­tem. VGL101 is a mon­o­clon­al an­ti­body ag­o­nist tar­get­ing TREM2, a mi­croglia sen­sor that me­di­ates re­spons­es to en­vi­ron­men­tal sig­nals and main­tains home­osta­sis in the brain.

“Mi­croglia sense sig­nals in the brain, main­tain home­osta­sis, and co­or­di­nate sig­nal-spe­cif­ic down­stream re­spons­es to clear pathogens and cel­lu­lar de­bris that can evolve in­to dis­ease-in­duc­ing agents,” Vig­il’s S-1/A states.

AL­SP is caused by a mu­ta­tion to the CSF1R gene, which con­verges down­stream with TREM2, Magov­če­vić-Liebisch ex­plained. The sci­en­tists be­lieve they can res­cue CSF1R func­tion by over-ac­ti­vat­ing TREM2, thus restor­ing mi­croglia func­tion.

Vig­il al­so has a small mol­e­cule TREM2 ag­o­nist pro­gram from Am­gen up its sleeve, which is still in the lead op­ti­miza­tion stage, ac­cord­ing to the biotech’s web­site. Re­searchers plan on se­lect­ing a de­vel­op­ment can­di­date in the first quar­ter of this year, ini­tial­ly tar­get­ing Alzheimer’s dis­ease, ac­cord­ing to the S-1/A.

Af­ter the of­fer­ing, Magov­če­vić-Liebisch now holds around 1.43% of the com­pa­ny’s stock, while At­las Ven­ture, which co-led the Se­ries A round, has a whop­ping 18.76% of the pie. North­pond Ven­tures, which al­so helped lead the Se­ries A, holds 13.66% of shares, while Am­gen has an 11.35% stake.

Vig­il’s now trad­ing un­der the tick­er $VIGL.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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