Is­rael's VBL Ther­a­peu­tics hit with CMC de­lays in ovar­i­an can­cer study; No­vo Hold­ings buys out di­ag­nos­tics play­er BBI

VBL Ther­a­peu­tics has hit a road­block in its Phase III study for plat­inum-re­sis­tant ovar­i­an can­cer.

Batch­es of the VB-111 com­pound be­ing eval­u­at­ed in the study are still be­ing re­viewed by the FDA’s CMC group, the com­pa­ny an­nounced Tues­day, with reg­u­la­tors try­ing to com­pare VB-111 man­u­fac­tur­ing be­tween dif­fer­ent sites. As a re­sult, sup­ply will be lim­it­ed and VBL is paus­ing en­roll­ment of the 400-pa­tient study un­til the batch­es can be cleared.

To date, VBL has re­cruit­ed about 75% of the ex­pect­ed pa­tient pool. The com­pa­ny says it’s work­ing on pro­vid­ing the re­quest­ed in­for­ma­tion to the FDA, and ex­pects to com­plete the new sub­mis­sion in the next two to three months.

“We do not ex­pect a ma­te­r­i­al change to our da­ta read­out time­lines,” CEO Dror Harats said in a state­ment. “We are in reg­u­lar con­tact with the FDA and tak­ing the steps nec­es­sary to min­i­mize dis­rup­tion to the tri­al in the US.”

The de­lay fol­lows an amend­ment to the tri­al, as rec­om­mend­ed by the FDA, to in­clude a co-pri­ma­ry end­point of pro­gres­sion free sur­vival. Pre­vi­ous­ly, the on­ly end­point had been over­all sur­vival, VBL said. Hit­ting ei­ther of the pri­maries “is ex­pect­ed to be suf­fi­cient to sup­port BLA sub­mis­sion.” — Max Gel­man

No­vo Hold­ings ac­quires di­ag­nos­tics and reagents play­er BBI Group

No­vo Hold­ings, the par­ent com­pa­ny of drug­mak­er No­vo Nordisk, has bought out a com­pa­ny in the di­ag­nos­tics and reagents field.

No­vo an­nounced the ac­qui­si­tion of BBI Group on Tues­day morn­ing, pick­ing it off from Ex­po­nent to the tune of about $563.1 mil­lion. BBI is head­quar­tered in South Wales, op­er­at­ing in sev­en coun­tries across four con­ti­nents.

Per the re­lease, BBI “pro­vides crit­i­cal reagents and im­munoas­say de­vel­op­ment, lat­er­al flow de­vel­op­ment, di­ag­nos­tic man­u­fac­tur­ing ser­vices, and smart­phone read­er tech­nolo­gies to a glob­al blue-chip cus­tomer base that in­cludes Ther­mo-Fish­er, Mer­ck and Siemens.” BBI So­lu­tions, the com­pa­ny’s lead­ing prod­uct, sup­plied things like an­ti­bod­ies, anti­gens, la­bels, com­ple­men­tary reagents and point of care tests.

“We are proud to be the next own­ers of BBI. Di­ag­nos­tics is a very at­trac­tive space which, with an en­hanced glob­al fo­cus on pre­ven­ta­tive med­i­cine, will play an in­creas­ing­ly im­por­tant part in im­prov­ing health out­comes for pa­tients around the world,” No­vo Hold­ings se­nior part­ner Jo­han Hu­ef­fer said in a state­ment. — Max Gel­man

NanoS­tring, PI­CI team up on mol­e­c­u­lar char­ac­ter­i­za­tion project for cell ther­a­pies

Seat­tle-based NanoS­tring Tech­nolo­gies has en­tered a re­search pact with the Park­er In­sti­tute for Can­cer Im­munother­a­py in San Fran­cis­co on a mol­e­c­u­lar char­ac­ter­i­za­tion project the part­ners hope will pro­vide a blue­print to de­vel­op­ing ef­fec­tive CAR-Ts across tu­mor types.

As part of the pact, the part­ners will lever­age PI­CI’s net­work of re­search cen­ters to test NanoS­tring’s CAR-T “char­ac­ter­i­za­tion pan­el.” The tech­nol­o­gy screens 780 genes to laser in on eight bi­o­log­i­cal char­ac­ter­is­tics the teams hope will al­low them to laser fo­cus on more ef­fec­tive CAR-Ts.

The re­sults from the part­ner­ship are ex­pect­ed to be made pub­lic as part of PI­CI’s Can­cer Da­ta and Ev­i­dence Li­brary plat­form, NanoS­tring said in a state­ment.

“By work­ing to­geth­er, NanoS­tring and PI­CI will gen­er­ate mean­ing­ful in­for­ma­tion from our sci­en­tif­ic com­mu­ni­ty to de­vel­op a stan­dard­ized ap­proach to cell ther­a­py de­vel­op­ment, al­low­ing us to bet­ter un­der­stand the at­trib­ut­es that make treat­ments ef­fec­tive and to ul­ti­mate­ly im­prove pa­tient out­comes,” NanoS­tring CSO and se­nior VP of R&D Joseph Beechem said in a state­ment. — Kyle Blanken­ship

FDA and Con­cer­tAI ink deal to study da­ta in ef­forts to im­prove can­cer treat­ment

A Boston-based AI life sci­ences com­pa­ny will col­lab­o­rate with the FDA on a 5-year re­search pro­gram in­volv­ing re­al-world out­comes of can­cer treat­ment, the com­pa­ny an­nounced Tues­day.

The col­lab­o­ra­tion will use Con­cer­tAI’s re­al-world da­ta to bet­ter un­der­stand the out­comes and safe­ty of cur­rent treat­ments in sub­pop­u­la­tions. Re­searchers will look to use tech­nol­o­gy that can aid in de­vel­op­ing strate­gies to im­prove pa­tient clin­i­cal out­comes, op­ti­mize the de­sign of clin­i­cal tri­als and help with safe­ty as­sess­ments.

In the press re­lease, CEO Jeff El­ton said:

The im­por­tance of RWD in the gen­er­a­tion of ev­i­dence has been ac­cel­er­at­ing. We see our col­lab­o­ra­tion with the FDA as gen­er­at­ing foun­da­tion­al re­search and method­olo­gies to ad­vance RWE’s po­ten­tial us­es. We look for­ward to bring­ing our RWD and da­ta sci­ence ex­per­tise to this col­lab­o­ra­tion to help cre­ate method­olo­gies for re­al-world ev­i­dence to ac­cel­er­ate more ef­fec­tive and safe on­col­o­gy ther­a­peu­tics.

The da­ta will come from elec­tron­ic med­ical records from pa­tients in aca­d­e­m­ic and com­mu­ni­ty can­cer care set­tings, such as the Can­cer­LinQ da­ta base from AS­CO. — Josh Sul­li­van

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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