Martin Babler, Esker

Fore­site's im­munol­o­gy play gets a $200M megaround for TYK2 pro­gram, re­brand­ing as Alu­mis

A Fore­site-in­cu­bat­ed biotech that de­buted just eight months ago closed a new mega fi­nanc­ing round on Thurs­day, and with it comes a com­pa­ny re­brand­ing.

Es­ker Ther­a­peu­tics will now call it­self Alu­mis fol­low­ing the com­ple­tion of a $200 mil­lion Se­ries B, the biotech an­nounced Thurs­day. The funds are ex­pect­ed to go to­ward Alu­mis’ pipeline, in­clud­ing its lead pro­gram ESK-001, a TYK2 in­hibitor tar­get­ing the pan-JAK path­way that the com­pa­ny has tout­ed as po­ten­tial­ly safer than cur­rent JAK in­hibitors.

“The fund­ing re­al­ly serves for us to ad­vance the pro­gram in­to the clin­ic, and then we have al­so a pipeline build­ing be­hind it,” CEO Mar­tin Babler told End­points News in an in­ter­view. “And we want to al­so make sure that we can take full ad­van­tage of our da­ta an­a­lyt­ics plat­form to re­al­ly ex­plore ad­di­tion­al tar­gets and ad­di­tion­al in­di­ca­tions.”

The lead com­pound is be­ing eval­u­at­ed in pso­ri­a­sis, and a Phase I safe­ty and tol­er­a­bil­i­ty study was ex­pect­ed to read out by the end of 2021. Though the com­pa­ny hasn’t put out a press re­lease with the da­ta yet, Babler said Alu­mis is “ex­treme­ly pleased” with the mol­e­cule.

“The fea­tures that we see is re­al­ly that we have a great PK pro­file, and that we have good se­lec­tiv­i­ty,” he said. “We’re on track to re­al­ly un­der­stand how this mol­e­cule stacks up against oth­ers in the field.”

For­mer CEO and founder June Lee had pre­vi­ous­ly said she ex­pect­ed the pro­gram to serve as a proof-of-con­cept for the rest of Alu­mis’ plat­form. By aim­ing to iden­ti­fy cer­tain ge­net­ic tar­gets, Lee not­ed she want­ed to serve pa­tients she felt had been in the “come-one-come-all” im­munol­o­gy mar­ket.

ESK-001 will have plen­ty of com­pe­ti­tion as the JAK field has seen much crowd­ing in re­cent years. Though Lee said Alu­mis’ mol­e­cule sprout­ed from the same class as Bris­tol My­ers Squibb’s deu­cravac­i­tinib, that drug beat out Am­gen’s Ote­zla in a piv­otal head-to-head pso­ri­a­sis tri­al last year, and the FDA has set a PDU­FA date for Sep­tem­ber.

“Fun­da­men­tal­ly, TYK2 is a mem­ber of the class of the JAK in­hibitors, but it has re­al­ly a dif­fer­en­ti­at­ed pro­file,” Babler said. “And one of the things about this mol­e­cule, it’s one of sev­er­al al­losteric TYK2 in­hibitors that are in de­vel­op­ment. And those in­hibitors re­al­ly don’t have a lot of JAK phar­ma­col­o­gy. And so we don’t re­al­ly see at least so far from from the lead­ing mol­e­cule in this class, which is the BMS mol­e­cule, and our own and oth­ers, the same phar­ma­col­o­gy that you see with JAK in­hibitors.”

Out­side this mol­e­cule, the com­pa­ny is aim­ing to de­vel­op oth­er can­di­dates in the im­munol­o­gy space, with Babler say­ing in a re­lease Thurs­day the com­pa­ny may look to ac­quire oth­er as­sets in ad­di­tion to build­ing out its pipeline.

The JAK space has been shak­en in re­cent months by re­peat­ed safe­ty is­sues, fol­low­ing a post-mar­ket­ing study for Pfiz­er’s Xel­janz that el­e­vat­ed the con­cerns in ear­ly 2021. De­spite the re­newed scruti­ny, the FDA has waved through new JAK in­hibitors re­cent­ly, ap­prov­ing Xel­janz and Ab­b­Vie’s Rin­voq for new in­di­ca­tions last month.

But the drugs came with ex­pand­ed warn­ings and a key la­bel change, say­ing they can on­ly be tak­en af­ter a pa­tient has failed on one or more TNF block­ers such as Hu­mi­ra. The shift came af­ter reg­u­la­tors flagged the risk of car­dio­vas­cu­lar events in pa­tients old­er than 50 with boxed warn­ings on Xel­janz, Rin­voq and Eli Lil­ly’s Olu­mi­ant.

“While we have a lead as­set, this is al­so about build­ing an en­tire pipeline be­hind it,” Babler said. “And so we are ac­tive­ly work­ing on sev­er­al oth­er pro­grams that we will dis­close at the ap­pro­pri­ate time.”

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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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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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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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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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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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.

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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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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