June Lee, Esker CEO

Vik Ba­ja­j's start­up in­cu­ba­tor at Fore­site un­cloaks an im­munol­o­gy play­er with a lead TYK2 in­hibitor in tow

Look­ing at a health­care sys­tem made more un­equal by Covid-19, Fore­site Cap­i­tal man­ag­ing di­rec­tor Vik Ba­jaj re­cent­ly kick­start­ed an ex­pan­sive plan to launch five in­no­v­a­tive star­tups to ad­dress un­met need. Just weeks af­ter the first of those biotechs emerged from stealth, a sec­ond has now un­cloaked, and it’s got im­munol­o­gy in its sights.

Es­ker Ther­a­peu­tics launched Wednes­day with a $70 mil­lion Se­ries A to pur­sue pre­ci­sion im­munol­o­gy tar­gets backed by Ba­jaj’s team at Fore­site, the biotech said. Fore­site foot­ed the en­tire round for Es­ker as it con­tin­ues to de­vel­op its pipeline and ad­vance its lead com­pound.

Un­der the lead­er­ship of founder and CEO June Lee, Es­ker is putting ESK-001, a TYK2 in­hibitor first fo­cused on pso­ri­a­sis, through its paces in a Phase I safe­ty and tol­er­a­bil­i­ty study in healthy pa­tients with a read­out ex­pect­ed by year’s end. Those re­sults will help pro­vide proof of con­cept for Es­ker’s dis­cov­ery plat­form, which the biotech hopes to lever­age to iden­ti­fy ge­net­ic tar­gets for pa­tients who have been left be­hind in the “come-one-come-all” im­munol­o­gy mar­ket, Lee told End­points News.

“I re­al­ly am ex­cit­ed by that vi­sion that we start­ed out with,” Lee said. “That we could do bet­ter in im­munol­o­gy than we have been do­ing. We’ve got to do what on­col­o­gy has been do­ing. There are a lot of pa­tients that haven’t been do­ing great, and I think that’s be­cause we fail to rec­og­nize the het­ero­gene­ity in these au­toim­mune con­di­tions.”

Vik Ba­jaj

Plat­form plays are noth­ing new in biotech, but Lee has rea­son to be­lieve in this one, pri­mar­i­ly be­cause of Ba­jaj’s lead­er­ship and mis­sion, she said. Lee al­so tout­ed her team’s pro­gram for TYK2, a sig­nal­ing path­way in the pan-JAK class, which is in the same chem­i­cal class, she said, as Bris­tol My­ers Squibb’s deu­cravac­i­tinib. That drug re­cent­ly won a head-to-head Phase III test against Am­gen’s Ote­zla in pso­ri­a­sis.

Pre­clin­i­cal da­ta have shown the Es­ker mol­e­cule’s promise as a tru­ly se­lec­tive mol­e­cule for TYK2, Lee said, a key as­ser­tion giv­en the on­go­ing safe­ty con­cerns about oth­er JAK in­hibitors, pri­mar­i­ly Pfiz­er’s Xel­janz. Lee knows there are a lot of play­ers out there tout­ing their own “tru­ly se­lec­tive” TYK2 com­pounds, but she thinks Es­ker’s mol­e­cule will even­tu­al­ly pull away from the pack.

“There’s a lot of peo­ple out there claim­ing to have the best com­pound, and it guess it de­pends on what you de­fine as best,” she said. “What I will say is we have a high­ly se­lec­tive TYK2 com­pound that is al­so high­ly de­risked.”

Lee, the for­mer chief de­vel­op­ment of­fi­cer at MyoKar­dia who joined the team in Feb­ru­ary, was one of a group of biotech lead­ers tapped as part of Ba­jaj’s ex­pan­sive plan to launch five star­tups uti­liz­ing his team’s en­gine to ad­dress un­met needs across the health­care spec­trum.

Es­ker joins Ses­ti­na Bio, a syn­thet­ic bi­ol­o­gy play­er aim­ing to cre­ate sus­tain­able sources for chem­i­cals and ma­te­ri­als, as the on­ly two of Fore­site Labs’ star­tups re­vealed to the pub­lic so far, but Ba­jaj told End­points last month that the oth­er com­pa­nies will fo­cus on pre­ci­sion med­i­cine in car­diometa­bol­ic dis­or­ders, map­ping the “pro­tein in­ter­ac­tome,” and col­lat­ing re­al-time, re­al-world da­ta.

“What we con­tin­ue to look for are en­tre­pre­neurs in res­i­dence who want to change this part of the world, change the health­care sys­tem and have the am­bi­tion to be on a plat­form like that,” Ba­jaj said. “That’s what’s re­al­ly go­ing to gate the num­ber of com­pa­nies that we cre­ate — it’s in find­ing those good re­la­tion­ships and peo­ple who re­al­ly want to adopt some­thing as their mis­sion or come to us with ideas that they think we can help with.”

Es­ker is cur­rent­ly work­ing with a full-time staff of four with plans to ex­pand as part of an “ag­gres­sive growth strat­e­gy” once the com­pa­ny locks in a lease in South San Fran­cis­co that is cur­rent­ly in the works, Lee said. Mean­while, Lee’s team is work­ing with about a dozen con­sul­tants at the start­up.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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