Io­vance has post­ed a first look at its tu­mor in­fil­trat­ing lym­pho­cytes as a treat­ment for non-small cell lung can­cer, paving the way for a piv­otal study.

Among 28 pa­tients en­rolled in Co­hort 3B of the IOV-COM-202 bas­ket study — 24 of whom were evalu­able — in­ves­ti­ga­tors record­ed an over­all re­sponse rate of 21.4% at the in­ter­im, with 1 com­plete re­sponse and 5 par­tial re­spons­es. All pa­tients in the group had pro­gressed on pri­or im­mune check­point in­hibitor ther­a­py, and some had re­ceived ty­ro­sine ki­nase in­hibitors. The six re­spon­ders al­so un­der­went chemother­a­py.

The me­di­an du­ra­tion of re­sponse was not yet reached af­ter 8.2 months of fol­lowup.

CMO Friedrich Graf Finck­en­stein called the da­ta “very promis­ing.”

“There re­mains a very sig­nif­i­cant un­met need to in­crease re­sponse rates and pro­long sur­vival in the sec­ond line non-small cell lung can­cer treat­ment set­ting,” he added.

Mizuho an­a­lyst Mara Gold­stein ev­i­dent­ly agreed, writ­ing in a note that the tri­al in­clud­ed a late-stage pop­u­la­tion.

“More en­cour­ag­ing­ly, the ini­tial dura­bil­i­ty seems con­sis­tent with that re­port­ed with TILs in melanoma, sug­gest­ing that durable re­spons­es may be a com­mon theme with TIL ther­a­py,” Boris Peak­er of Cowen echoed.

The biotech, which is lead­ing with the cer­vi­cal can­cer in­di­ca­tion, said it has dosed the first pa­tient in IOV-LUN-202, a po­ten­tial­ly reg­is­tra­tional study ded­i­cat­ed for sec­ond-line pa­tients who have pro­gressed on one pri­or check­point and chemo. — Am­ber Tong

An­tios and Ar­bu­tus join hands on HBV com­bo treat­ment

A few days af­ter an­nounc­ing its he­pati­tis B can­di­date worked as billed as a monother­a­py, An­tios Ther­a­peu­tics is un­veil­ing a part­ner­ship to pair the drug with Ar­bu­tus’ RNAi ther­a­py AB-729 and Gilead’s Viread.

The com­bi­na­tion will be as­sessed in a co­hort of the on­go­ing Phase IIa ANTT201 tri­al. An­tios will foot the bill for that por­tion of the tri­al, which is ex­pect­ed to kick off in the sec­ond half of this year. Ar­bu­tus will take re­spon­si­bil­i­ty for the man­u­fac­tur­ing and sup­ply of AB-729.

Greg Mayes

“ATI-2173 has, to date, demon­strat­ed a well-tol­er­at­ed safe­ty pro­file and sus­tained on- and off-treat­ment an­tivi­ral re­spons­es as a monother­a­py in pa­tients with chron­ic HBV,” An­tios CEO Greg Mayes said in a state­ment.

The can­di­date is an in­ves­ti­ga­tion­al pro­drug of cle­vu­dine, which has his­tor­i­cal­ly demon­strat­ed po­tent and sus­tained re­duc­tions in HBV vi­ral load. How­ev­er, high plas­ma lev­els of cle­vu­dine have been as­so­ci­at­ed with re­versible my­opa­thy, ac­cord­ing to CMO Dou­glas May­ers. ATI-2173 was de­signed to have a sim­i­lar mech­a­nism of ac­tion in the liv­er, with min­i­mal plas­ma ex­po­sure.

“We be­lieve that its unique mech­a­nism of ac­tion and ear­ly ev­i­dence of clin­i­cal ac­tiv­i­ty may po­si­tion ATI-2173 as the back­bone of a once-dai­ly cu­ra­tive reg­i­men in com­bi­na­tion with oth­er agents for chron­ic HBV,” Mayes said. — Nicole De­Feud­is 

Nor­we­gian ra­dio­phar­ma play­er lands $29M

Rid­ing on the grow­ing mo­men­tum for ra­dio­phar­ma, a Nor­we­gian biotech has raised NOK 250 mil­lion ($29.19 mil­lion) to fund mid-stage clin­i­cal stud­ies in ovar­i­an and col­orec­tal can­cer.

The next step, On­coin­vent was ea­ger to share, will be an IPO in the com­ing year.

Thanks to en­thu­si­as­tic sup­port from Hadean Ven­tures, Gev­er­an, RAD­FORSK In­vester­ingss­tif­telse, Sundt, Must In­vest, Cani­ca, MP Pen­sjon and Wa­tri­um, On­coin­vent ac­tu­al­ly upped the round, CEO Jan Alfheim said, al­low­ing them to start pre­clin­i­cal de­vel­op­ment of two can­di­dates ear­li­er than planned.

Like oth­ers in the space — from phar­ma gi­ant No­var­tis to up­starts like Rayze­Bio and Ak­tis — On­coin­vent is all about de­liv­er­ing al­pha-emit­ting par­ti­cles pre­cise­ly to where the tu­mors are. What sets it apart, ac­cord­ing to the com­pa­ny, is the way it for­mu­lates the ra­dioiso­topes in a sus­pen­sion of in­or­gan­ic mi­cros­pheres. That means they can go af­ter can­cer metas­tases on in­tra­cav­i­tary sur­faces and liq­uid vol­umes with­out go­ing too deep in­to or­gans and tis­sues.

The lead can­di­date, Rad­spherin, is cur­rent­ly in Phase I tri­als. — Am­ber Tong

Look­ing to turn an­ti­body in­to ADC, In­novent taps Dutch part­ner

Hav­ing long brand­ed it­self as a lead­ing an­ti­body de­vel­op­er in Chi­na, In­novent is branch­ing out.

The Suzhou-based com­pa­ny is team­ing up with Synaf­fix, a Dutch spe­cial­ist of an­ti­body-drug con­ju­gates, to lever­age one of its own an­ti­bod­ies and make a best-in-class ADC can­di­date. With­out spec­i­fy­ing which one, In­novent said it will have ac­cess to Synaf­fix’s suite of tech­nolo­gies.

The deal fol­lows an ini­tial re­search pe­ri­od in which the two com­pa­nies worked to­geth­er on proof-of-con­cept. Synaf­fix will con­tin­ue to help with the ex­per­i­ments as well as man­u­fac­tur­ing of any ADC-re­lat­ed parts. — Am­ber Tong

Gilead races to the fin­ish line with a new HIV can­di­date for drug-re­sis­tant pa­tients

HIV pa­tients who have de­vel­oped re­sis­tance to mul­ti­ple drugs could soon have an­oth­er op­tion. Gilead has sub­mit­ted a new drug ap­pli­ca­tion for its long-act­ing HIV-1 cap­sid in­hibitor lenaca­pavir, the com­pa­ny said on Mon­day.

The fil­ing is based on da­ta from the Phase II/III CAPEL­LA tri­al which showed that 88% of pa­tients in the treat­ment arm achieved a mean­ing­ful vi­ral load re­duc­tion (at least 0.5 log10) com­pared to just 17% in the place­bo arm over a 14-day pe­ri­od (p<0.0001). The drug was gen­er­al­ly well-tol­er­at­ed, with no se­ri­ous ad­verse events re­lat­ed to the study and no dis­con­tin­u­a­tions in the 14-day pe­ri­od, ac­cord­ing to Gilead.

“We ac­knowl­edge the sal­vage HIV mar­ket is <10% of the to­tal mar­ket and per­haps not too ma­te­r­i­al to GILD’s top-line,” Jef­feries’ Michael Yee said back in No­vem­ber, when Gilead read out the first piv­otal re­sults. “But this is an im­por­tant step to­wards broad­en­ing of the long-act­ing op­por­tu­ni­ty in­to the big­ger on-treat­ment and PrEP mar­kets.”

At the time, Yee said Gilead’s can­di­date was look­ing bet­ter than fos­tem­savir — a GSK drug com­mon­ly giv­en to HIV pa­tients with drug re­sis­tance. In a piv­otal tri­al, just 68% of pa­tients on fos­tem­savir achieved the re­quired vi­ral load re­duc­tion. — Nicole De­Feud­is

Eikonok­lastes Ther­a­peu­tics clos­es Se­ries A fundrais­ing

An Ohio-based bio­phar­ma has com­plet­ed its Se­ries A round of fundrais­ing, but hasn’t yet dis­closed that num­ber, the com­pa­ny an­nounced Tues­day.

Eikonok­lastes Ther­a­peu­tics round was led by Cin­cyTech with par­tic­i­pa­tion from Elk Cap­i­tal Ven­tures, Jobs Ohio and Rev1. The funds will be used to pre­pare IND stud­ies for L-ICON3, a tis­sue fac­tor im­munother­a­py for the treat­ment of triple-neg­a­tive breast can­cer, which ac­counts for 15% of all breast can­cers, the com­pa­ny said in a press re­lease. The drug tar­gets tis­sue fac­tor, but not healthy cells.

The com­pa­ny closed its over­sub­scribed seed fi­nanc­ing in Ju­ly 2020. The Ohio State Uni­ver­si­ty Cor­po­rate En­gage­ment Of­fice is al­so in­volved with the project. — Josh Sul­li­van

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.