Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­er­s' Op­di­vo notch­es a dou­ble win against chemo in esophageal can­cer, po­ten­tial­ly set­ting up 1st-line nod

Bris­tol My­ers Squibb is one of a group of drug­mak­ers prep­ping for a tense FDA ad­comm lat­er this month to re­view a host of ac­cel­er­at­ed ap­provals. Look­ing to start the month on the right note, the drug­mak­er rolled out new da­ta for its PD-(L)1 check­point in­hibitor Op­di­vo show­ing more promise in esophageal can­cer.

Op­di­vo in com­bi­na­tion with chemother­a­py and a com­bi­na­tion of Op­di­vo and Yer­voy beat out chemo alone in ex­tend­ing the lives of first-line esophageal squa­mous cell car­ci­no­ma pa­tients whose tu­mors are metasta­t­ic or can’t be sur­gi­cal­ly re­moved, ac­cord­ing to in­ter­im re­sults re­leased Thurs­day.

A com­bi­na­tion of Op­di­vo and chemo hit its pri­ma­ry OS and PFS end­points over chemo alone in PD-(L)1 ex­press­ing tu­mors at a pre­spec­i­fied check-in on the Phase III CHECK­MATE-648 study. Mean­while, Op­di­vo plus Yer­voy showed more mixed re­sults, hit­ting its OS pri­ma­ry end­point but miss­ing the PFS co-pri­ma­ry end­point, Bris­tol My­ers said.

Bris­tol My­ers is tout­ing the re­sults as the first time a PD-(L)1 check­point in­hibitor has shown first-line ef­fi­ca­cy across all up­per GI tu­mor lo­ca­tions, in­clud­ing in the stom­ach, gas­troe­sophageal junc­tion, and esoph­a­gus. The study backed up re­sults from CHECK­MATE-649, which test­ed Op­di­vo plus chemo in first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma.

The FDA agreed to re­view re­sults from that study as part of a pri­or­i­ty re­view grant­ed in Feb­ru­ary, with an ac­tion date set for May 25. Earn­ing a nod in those ear­ly pa­tients would be a clear leg up on Mer­ck’s su­per­star check­point in­hibitor Keytru­da, which sports an ap­proval in third-line pa­tients with the PD-(L)1 bio­mark­er dat­ing back to Sep­tem­ber 2017 but has since flopped con­fir­ma­to­ry tri­als in first- and sec­ond-line use.

CHECK­MATE-648 is an­oth­er win un­der Bris­tol My­ers’ belt as it pre­pares for a three-day ad­comm in April to re­view a broad range of im­mune check­point in­di­ca­tions with ac­cel­er­at­ed ap­provals that flopped con­fir­ma­to­ry stud­ies, in­clud­ing a sin­gle Op­di­vo in­di­ca­tion.

In De­cem­ber, Bris­tol walked on Op­di­vo’s third-line-or-lat­er FDA ap­proval for small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod in that in­di­ca­tion back in 2018 failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. Based on find­ings from its Check­mate-451 and -331 tri­als, which found Op­di­vo failed to hit its OS pri­ma­ry end­points as both a monother­a­py and com­bo treat­ment with Yer­voy, Bris­tol de­cid­ed to pull its ap­proval based on the FDA’s rec­om­men­da­tions to fol­low post-mar­ket­ing sci­ence.

Just a week be­fore that, Bris­tol opt­ed to for­go its chances in brain can­cer glioblas­toma, an­oth­er chron­i­cal­ly dif­fi­cult-to-treat in­di­ca­tion, fol­low­ing mul­ti­ple clin­i­cal fails. The drug­mak­er ad­mit­ted a com­bo of Op­di­vo on top of stan­dard-of-care temo­zolo­mide plus ra­di­a­tion couldn’t beat place­bo in ex­tend­ing over­all sur­vival in pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme who pre­vi­ous­ly had their tu­mor sur­gi­cal­ly re­moved.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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George Yancopoulos, Regeneron

Re­gen­eron's lat­est ge­net­ics dis­cov­ery hooks As­traZeneca — now all-in on de­vel­op­ing small mol­e­cules for obe­si­ty

Just weeks after its widely lauded genetics research arm tagged a promising new target for obesity, Regeneron has signed up an industry heavyweight to collaborate with on developing new drugs that can potentially act as a game-changer in what has proven to be a tough field for developers.

The Regeneron Genetics Center published a paper in Science at the beginning of this month highlighting how their work sequencing the genomes of 650,000 people highlighted how people with at least 1 inactive copy of the GPR75 gene weighed on average 12 pounds less than the rest of the population with a 54% reduction in risk of obesity.

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