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.

I am rag­ing. Tell me why the great­est democ­ra­cy in the world would elect a cryp­to-dic­ta­tor, al­low him lie to the na­tion for 4 years, then launch a full out phys­i­cal as­sault on our in­sti­tu­tions- and un­til now not one of his Cab­i­net re­signed???? #cab­i­ne­tre­sign­now

— Je­re­my Levin (@jmaxlevin) Jan­u­ary 6, 2021

“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 

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.