PhI­II deal­mak­ing fren­zy in i/o con­tin­ues as As­traZeneca fol­lows PA­CIF­IC with a new In­cyte IDO1 com­bo

In­cyte CEO Hervé Hop­penot made it clear a long time ago that he was hap­pi­ly fast and loose about which ap­proved PD-(L)1 drug he part­nered with on his IDO1 drug epaca­do­stat. He launched piv­otal com­bo stud­ies with Mer­ck and Bris­tol-My­ers Squibb, and now he’s kick­ing off a new Phase III tie-up with As­traZeneca’s Imfinzi (dur­val­um­ab) in stage III non-small cell lung can­cer, con­tin­u­ing a re­la­tion­ship that dates back three years.

Hervé Hop­penot

For As­traZeneca, this is a chance to fol­low up on its PA­CIF­IC study af­ter un­veil­ing some (very bad­ly need­ed) pos­i­tive da­ta in Sep­tem­ber for in­op­er­a­ble, lo­cal­ly ad­vanced stage 3 lung can­cer where the can­cer had not ad­vanced af­ter chemo.

Stage 3 it­self rep­re­sents a third of NSCLC in­ci­dence, and As­traZeneca CEO Pas­cal So­ri­ot with chief med­ical of­fi­cer Sean Bo­hen ex­plained at ES­MO that it po­si­tioned Imfinzi as the lead check­point in the front half of the crit­i­cal lung can­cer mar­ket for stages 1 through 3, with a strate­gic ad­van­tage for mov­ing in­to stage 4 cas­es.

That suc­cess was re­port­ed just two months af­ter a ma­jor set­back on their late-stage com­bo study us­ing dur­val­um­ab with the CT­LA-4 drug treme­li­mum­ab, which failed the first leg of a two-part piv­otal tri­al. That helped raise new doubts about the fu­ture of CT­LA-4 drug com­bi­na­tions, though As­traZeneca has con­sid­er­able hope that the over­all sur­vival stats in the study will be pos­i­tive.

Sean Bo­hen

The new com­bo study al­so high­lights the fren­zy of part­ner­ing that’s been go­ing on in the check­point field. PD-(L)1 drugs can be used sys­tem­i­cal­ly against a wide range of on­col­o­gy tar­gets and have a lot of po­ten­tial in terms of com­bi­na­tions with more tar­get­ed agents. It al­so fol­lows close­ly on the heels of a new deal that In­cyte struck with Macro­Gen­ics to in-li­cense an ex­per­i­men­tal PD-1 drug af­ter their own in-house pro­gram ran smack in­to some safe­ty is­sues, es­sen­tial­ly ru­in­ing its com­mer­cial po­ten­tial.

“Imfinzi has shown ex­cit­ing clin­i­cal po­ten­tial in treat­ing pa­tients with lo­cal­ly-ad­vanced lung can­cer. We are pleased to build on re­cent da­ta from the PA­CIF­IC tri­al to fur­ther ex­plore how Imfinzi, in com­bi­na­tion with an IDO1 en­zyme in­hibitor, could pro­vide ad­di­tion­al ben­e­fit to pa­tients with lo­cal­ly-ad­vanced lung can­cer,” said Sean Bo­hen, As­traZeneca’s chief med­ical of­fi­cer.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,000+ biopharma pros reading Endpoints daily — and it's free.

Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.