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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.