News brief­ing: Ab­b­Vie se­lects first tar­get for Drag­on­fly part­ner­ship; Cog­ni­to nets BDD for Alzheimer's treat­ment de­vice

Drag­on­fly’s part­ner­ship with Ab­b­Vie is be­gin­ning to bear fruit.

Ab­b­Vie has se­lect­ed its first NK cell en­gager-based im­munother­a­py as part of the deal, trig­ger­ing an undis­closed opt-in pay­ment, the com­pa­nies an­nounced Tues­day. Ab­b­Vie will gain ex­clu­sive world­wide rights to de­vel­op and com­mer­cial­ize prod­ucts di­rect­ed to this first tar­get, which is al­so undis­closed, and Drag­on­fly be­comes el­i­gi­ble for fu­ture mile­stones and roy­al­ties.

“This opt-in, so soon af­ter launch­ing our col­lab­o­ra­tion, is a great vote of con­fi­dence,” Drag­on­fly CEO Bill Haney said in a state­ment. “We look for­ward to con­tin­ued suc­cess and rapid progress with the Ab­b­Vie team.”

The pair signed their col­lab­o­ra­tion back in No­vem­ber 2019. So far, all of Drag­on­fly’s col­lab­o­ra­tions have net­ted $800 mil­lion in up­front pay­ments and ear­ly mile­stones. The biotech is el­i­gi­ble for up to $17 bil­lion in to­tal mile­stones should it achieve them all.

Tues­day’s se­lec­tion comes out of Drag­on­fly’s TriN­KET plat­form, build­ing tri-spe­cif­ic NK cell en­gager ther­a­pies. Drag­on­fly has al­so signed on to three deals with Bris­tol My­ers Squibb, the most re­cent of which came last Ju­ly, and two with Mer­ck. — Max Gel­man

FDA grants Cog­ni­to break­through des­ig­na­tion in Alzheimer’s

Cog­ni­to Ther­a­peu­tics has re­ceived a break­through de­vice des­ig­na­tion for one of the tough­est fields in the in­dus­try — Alzheimer’s dis­ease.

The FDA hand­ed down the des­ig­na­tion Tues­day morn­ing, Cog­ni­to an­nounced, say­ing the agency is plan­ning to re­view its lead prod­uct for the treat­ment of cog­ni­tive and func­tion­al symp­toms as­so­ci­at­ed with Alzheimer’s.

Cog­ni­to says it has de­vel­oped a non-in­va­sive de­vice that us­es gam­ma fre­quen­cy tech­nol­o­gy to stem Alzheimer’s symp­toms. Re­searchers at the com­pa­ny say they found stim­u­lat­ing the brain at a spe­cif­ic fre­quen­cy had the ef­fect of re­ac­ti­vat­ing the im­mune sys­tem in the brain, cor­re­lat­ing with a re­duc­tion in amy­loid plaques and tau tan­gles.

In prac­tice, this could look like an Alzheimer’s pa­tient be­ing ex­posed to strobe lights and click­ing sounds. A study in mice ap­peared to show im­prove­ments in cog­ni­tive and mem­o­ry skills, per the New York Times.

With­in that study, light and sound de­liv­ered to mice at 40 hertz, or 40 flash­es or clicks per sec­ond, os­ten­si­bly syn­chro­nized with the rhythm of the brain’s gam­ma waves. That led to an in­crease in trash-clear­ing and im­mune-reg­u­lat­ing func­tions with­in the brains. — Max Gel­man

BIO chief Michelle Mc­Mur­ry-Heath con­demns Capi­tol vi­o­lence, paus­es po­lit­i­cal con­tri­bu­tions

BIO pres­i­dent and CEO Michelle Mc­Mur­ry-Heath has been clear about the as­so­ci­a­tion’s po­si­tion on the mob vi­o­lence on Capi­tol Hill last week. On Mon­day, she took it one step fur­ther, an­nounc­ing that BIO will pause its po­lit­i­cal con­tri­bu­tions for the time be­ing.

“As of to­day BIO will be paus­ing our po­lit­i­cal giv­ing so we can re­assess the cri­te­ria up­on which we sup­port po­lit­i­cal can­di­dates in the fu­ture. As a mem­ber­ship or­ga­ni­za­tion we owe it to our mem­bers to hear their voic­es in this im­por­tant de­ci­sion,” Mc­Mur­ry-Heath said in the state­ment.

“One of the five new strate­gic pil­lars that BIO an­nounced last fall is to be the voice of and for sci­ence and at its core sci­ence is the search for truth based on ev­i­dence. So it is very con­cern­ing that some elect­ed lead­ers last week chose to ig­nore facts and em­brace wide­ly dis­cred­it­ed con­spir­a­cies which in part led to the hor­rif­ic events at the Capi­tol,” she con­tin­ued.

Last week, the CEO joined many oth­er bio­phar­ma lead­ers in con­demn­ing the vi­o­lence. “It is sim­ply un­con­scionable for an an­gry mob, up­set by an elec­tion out­come to try to dis­en­fran­chise the votes of mil­lions of Amer­i­cans sim­ply be­cause their cho­sen can­di­date lost,” she said.

Je­re­my Levin, chair­man of BIO, post­ed a sim­i­lar­ly heat­ed re­sponse on Twit­ter on Jan 6.

“Our mem­bers take this se­ri­ous­ly and so do we,” Mc­Mur­ry-Heath said in the state­ment. — Nicole De­Feud­is 

Ada­gene and NHLBI dis­cov­er new CAR-T can­di­date

Ada­gene and the Na­tion­al Heart, Lung, and Blood In­sti­tute say they’ve come up with a new kind of CAR-T can­di­date for re­nal cell car­ci­no­ma, based on an­ti­bod­ies dis­cov­ered by the Suzhou, Chi­na-based biotech.

The part­ners say the can­di­date is the first — that they’re aware of — to tar­get a hu­man en­doge­nous retro­virus (HERV) ex­pressed in the ma­jor­i­ty of clear cell kid­ney tu­mors. HERVs are rem­nants of an­cient germ-line in­fec­tions with ex­oge­nous retro­virus­es, and are es­ti­mat­ed to com­prise up to 8% of the hu­man genome.

The can­di­date was de­vel­oped in the lab of Richard Childs, chief of the NHLBI’s Lab­o­ra­to­ry of Trans­plan­ta­tion Im­munother­a­py. From here, the NIH will take over man­u­fac­tur­ing and clin­i­cal de­vel­op­ment.

“This is an en­cour­ag­ing de­vel­op­ment that builds on decades of re­search in our quest to find ways to adapt and en­hance im­mune cells to tar­get and kill even the most ag­gres­sive can­cers,” Childs said in a state­ment. “I look for­ward to the eval­u­a­tion and hope­ful­ly the de­vel­op­ment of this nov­el CAR-T cell and oth­er an­ti­body-based ther­a­pies in clin­i­cal tri­als.”

The can­di­date was dis­cov­ered us­ing Ada­gene’s NEO­body tech, which is part of its Dy­nam­ic Pre­ci­sion Li­brary. Last Jan­u­ary, Ada­gene nabbed a $69 mil­lion Se­ries D to ad­vance its an­ti­body work. — Nicole De­Feud­is 

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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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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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.

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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Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal.

Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.