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

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Chica­go-area biotech sends 2nd drug to In­di­a's reg­u­la­tors; Pen­ny stock play­er spins out PhI­II can­cer can­di­date in­to new com­pa­ny

Pharmazz is on its way to India’s drug regulator for the second time as its investigational treatment passed muster in a Phase III study in patients with acute ischemic stroke.

The Chicago suburbs-based biotech said its drug sovateltide led to better improvement than placebo on certain measurements of neurological outcomes.

Sovateltide led an improvement of ≥2 points on mRS and an increase of ≥6 points on NIHSS at day 90 in the trial of 158 adults in India. The modified Rankin scale looks at the degree of dependence in the daily activities of people post-stroke event, and the NIH stroke scale measures the stroke-related neurologic deficit.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.