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 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.

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.