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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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