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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Paul Hastings, Nkarta CEO

With no up­front pay­ment or mile­stones on the line, Nkar­ta and CRISPR join forces on CAR-NK search

Most deals in biotech come with hefty upfront payments attached, and the promise of big biobucks if a program works out. Not this one.

Nkarta has struck what CEO Paul Hastings calls a “real collaboration” with CRISPR Therapeutics to co-develop and commercialize two CAR-NK therapies, in addition to an NK+T program. The duo will split all R&D costs — and any worldwide profits — 50/50, Hastings said.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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