Alice Zhang, founder and CEO of Verge Genomics

Al­ice Zhang's 'all-in-hu­man' AI and ge­nomics up­start scores a $98M Se­ries B

Just a few months af­ter Cal­i­for­nia AI and ge­nomics play­er Verge Ge­nomics part­nered with Eli Lil­ly in a $700 mil­lion-plus biobucks deal for 4 neu­ro­log­i­cal pro­grams, the biotech has fin­ished rais­ing its next fi­nanc­ing round — net­ting $98 mil­lion in eq­ui­ty fund­ing with Lil­ly jump­ing on board as a new in­vestor.

The South San Fran­cis­co-based, neu­ro­science-fo­cused com­pa­ny an­nounced the com­ple­tion of the Se­ries B this morn­ing, which was led by Black­Rock-man­aged funds and sup­port­ed by some new big-name in­vestors such as Eli Lil­ly, Mer­ck’s Glob­al Health In­no­va­tion Fund and Vul­can Cap­i­tal. Some ex­ist­ing in­vestors joined in as well, in­clud­ing ALS In­vest­ment Fund and Tao Cap­i­tal Part­ners.

Ac­cord­ing to Verge, the $98 mil­lion from the round will be used to ad­vance lead pro­grams in­to the clin­ic and grow their pipeline with dis­cov­ery, pre­clin­i­cal and clin­i­cal pro­grams.

Hir­ing more em­ploy­ees is al­so on Verge’s to-do list, as the biotech cur­rent­ly has 32 em­ploy­ees — and the plan is to dou­ble that in the next 12-18 months.

The biotech has been fo­cused on its dis­cov­ery and pre­clin­i­cal plat­form, where it seeks to dis­tin­guish it­self with an “all-in-hu­man” ap­proach.

To sum­ma­rize, the biotech se­quences genomes de­rived from hu­man brain sam­ples — and in the case of ALS, spinal sam­ples as well. These se­quences then get fed in­to Verge’s ma­chine learn­ing soft­ware, which is where AI comes in — and from that da­ta, it sug­gests po­ten­tial drug tar­gets.

Why go the hu­man sam­ple route, in­stead of the more com­mon mice or lab rats?

In short, “The over­all idea is that we can not on­ly use tech­nol­o­gy to ac­cel­er­ate drug de­vel­op­ment it­self, but then de­vel­op drugs that are more like­ly to suc­ceed in hu­mans, be­cause we’re start­ing in hu­mans,” Verge CEO and founder Al­ice Zhang told End­points News.

“Verge has be­come one of the first AI-en­abled drug dis­cov­ery com­pa­nies to dis­cov­er a nov­el tar­get and de­vel­op it in­ter­nal­ly in­to a pro­pri­etary clin­i­cal can­di­date en­tire­ly us­ing its plat­form,” the biotech tout­ed in its press re­lease. And ac­cord­ing to Zhang, that drug can­di­date is its lead can­di­date in ALS — which the biotech hopes to have in the clin­ic some­time next year. That can­di­date is a PIK­fyve gene in­hibitor, which Verge said back in Ju­ly has shown a con­nec­tion to ALS.

Alexander Lefterov/Endpoints News

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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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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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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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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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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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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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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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.