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 

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

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.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

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.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

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.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

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.