Crack­ing the IL-2 puz­zle box has been a point of con­tention in biotech for years as drug de­vel­op­ers look to beat a slate of se­ri­ous side ef­fects. An­oth­er play­er in that ef­fort has piqued the in­ter­est of in­vestors and is now flush with cash to take the next step in­to hu­man stud­ies.

Ash­er Bio­ther­a­peu­tics closed a $108 mil­lion Se­ries B led by Welling­ton Man­age­ment Com­pa­ny with biotech blue-chip­per RA Cap­i­tal al­so on board to ad­vance its lead “cis-tar­get­ed” IL-2 drug through the clin­ic with more from its “mod­u­lar” plat­form geared up for tri­als, the biotech said Wednes­day.

The round was al­so joined by new in­vestors Janus Hen­der­son In­vestors, Lo­gos Cap­i­tal, Mar­shall Wace and Alexan­dria Ven­ture In­vest­ments along with ex­ist­ing in­vestors Third Rock Ven­tures, In­vus, Box­er Cap­i­tal of Tavi­s­tock Group, Mis­sion Bio­Cap­i­tal, and oth­er undis­closed in­sti­tu­tion­al in­vestors.

The funds will be used to ad­vance Ash­er’s lead drug, dubbed AB248, an en­gi­neered IL-2 tar­get­ing CD8+ ef­fec­tor T cells, through a proof-of-con­cept hu­man study while al­so ad­vanc­ing at least one oth­er pro­gram through IND-en­abling stud­ies. Ash­er’s sales pitch is that its IL-2, en­gi­neered to ex­hib­it few­er dele­te­ri­ous side ef­fects while more ef­fec­tive­ly tar­get­ing sur­face tu­mor anti­gens, could prove a game chang­er in the race to de­vel­op a bet­ter cy­tokine.

Ash­er is re­ly­ing on a “mod­u­lar” de­sign pro­gram for its fol­low-on pipeline, us­ing com­mon fea­tures from its en­gi­neered cy­tokines across mul­ti­ple ther­a­peu­tic ar­eas, CEO Craig Gibbs told End­points News. Con­sid­er the next two drugs in Ash­er’s pipeline: One is a STAT3 cy­tokine en­gi­neered with the same CD8+ T cell re­cep­tor, while the sec­ond is an en­gi­neered IL-2 with a CAR-T re­cep­tor.

Prov­ing proof of con­cept in AB248, Gibbs ar­gued, should have some fol­low-through on the rest of the pipeline. But that hu­man proof is still yet to come.

But Ash­er had enough da­ta on hand to en­tice RA, a fre­quent in­vestor in the space. Gibbs said Ash­er is now RA’s fifth next-gen IL-2 play — a sign in his team’s mind that the plat­form is good enough to be con­sid­ered a fron­trun­ner in the space.

“Our plat­form is quite unique and is dif­fer­ent from what a lot of oth­er peo­ple are do­ing,” Gibbs said. “We think those ap­proach­es are valid and can ap­prove se­lec­tiv­i­ty, but there’re like­ly in­cre­men­tal.”

Mean­while, Ash­er’s team of 33 will look to ex­pand as clin­i­cal ex­pan­sion ap­proach­es, but Gibbs was most­ly mum on what the hir­ing num­bers would look like.

Ei­ther way, the com­pa­ny is laser fo­cused on its lead pro­grams and didn’t of­fer much in terms of whether a pub­lic of­fer­ing was on the near hori­zon. Gibbs said Ash­er would keep its op­tions open, con­sid­er­ing non-di­lu­tive fund­ing op­tions like ven­ture debt, phar­ma part­ner­ships or oth­er­wise to spur growth, along­side the po­ten­tial for an IPO.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.