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 

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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