Io­vance's TIL ther­a­py makes ear­ly head­way in lung can­cer; An­tios and Ar­bu­tus join hands on HBV com­bo treat­ment

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Take­da snaps up the Japan­ese rights to an old Shire cast-off; Boehringer In­gel­heim ac­quires Abexxa Bi­o­log­ics

A week before the FDA is set to decide on Mirum Pharmaceuticals’ lead liver disease drug — an old Shire cast-off called maralixibat — Takeda is swooping in to secure the rights in Japan.

Maralixibat’s roots trace back to Lumena, which was snapped up by Shire for $260 million-plus back in 2014. While the candidate had failed mid-stage studies at Shire, Mirum believes better trial design and patient selection will deliver the wins it needs. The drug is currently in development for Alagille syndrome (a condition called ALGS in which bile builds up in the liver), progressive familial intrahepatic cholestasis (PFIC, which causes progressive liver disease) and biliary atresia (a blockage in the ducts that carry bile from the liver to the gallbladder).

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.