Affini­vax, Astel­las be­gin clin­i­cal quest to beat Pfiz­er's Go­liath with a new kind of pneu­mo­coc­cal vac­cine

Days af­ter the FDA blessed Mer­ck’s ef­fort to chal­lenge Pfiz­er’s mega-block­buster Pre­vnar 13 with a break­through des­ig­na­tion, Affini­vax is mak­ing the leap in­to the clin­ic with its own take on the pneu­mo­coc­cal vac­cine.

It’s no small feat for a biotech play­er that got start­ed with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion in 2014 and has been run­ning pure­ly on grants as well as part­ner­ship dol­lars from Astel­las — which is shoul­der­ing much of clin­i­cal work in the Phase I/II study.

“We’ve done in less than five years at Affini­vax what the big vac­cine play­ers like Mer­ck and Pfiz­er and Sanofi and GSK have been try­ing to do for over 20 years,” CEO Steve Brug­ger tells me. “We have ac­tu­al­ly de­vel­oped a true next gen­er­a­tion tech­nol­o­gy for vac­cines.”

Rick Mal­ley

Hav­ing spent the past few years in­dus­tri­al­iz­ing the tech­nol­o­gy that came out of Rick Mal­ley’s lab at Boston Chil­dren’s Hos­pi­tal, Brug­ger and his crew of 68 are con­fi­dent that its prod­uct, ASP3772, can pro­vide “broad­er pro­tec­tion than any vac­cine in the mar­ket or any vac­cine that we’re aware of in clin­i­cal test­ing to­day.”

The spe­cif­ic num­ber of serotypes it will cov­er, though, will be kept se­cret for a lit­tle longer.

Dubbed the mul­ti­ple anti­gen pre­sent­ing sys­tem, or MAPS, Affini­vax’s tech plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, thus re­duc­ing cross-link­ing be­tween pro­teins and poly­sac­cha­rides. More im­por­tant­ly, the pro­teins — mere car­ri­ers in tra­di­tion­al vac­cines — are de­signed to elic­it B and T cell re­spons­es along­side the poly­sac­cha­rides they are bound to.

It’s an ap­proach that’s sup­posed to sep­a­rate Affini­vax from both the big guys and small­er chal­lengers like SutroVax, which has $170 mil­lion to push its own first-in-class con­ju­gate vac­cine to the clin­ic.

That will all be put to the test in the 618-pa­tient tri­al, as ASP3772 gets ad­min­is­tered to both adults and el­der­ly, and com­pared against Pre­vnar 13 as well as Pneu­movax.

Mean­while, the launch of the tri­al has trig­gered a mile­stone pay­ment from Astel­las — $10 mil­lion in cash that will fund Affini­vax’s oth­er bac­te­r­i­al vac­cine projects and some ear­ly, ex­plorato­ry work on im­muno-on­col­o­gy, where the abil­i­ty to present mul­ti­ple im­mune-re­sponse in­duc­ing anti­gens seems to hold promise.

“We stayed home for the first four years and fo­cused on let’s get the lead flag­ship pro­gram in­to the clin­ic, let’s val­i­date the tech­nol­o­gy clin­i­cal­ly, which we’re on track to do,” Brug­ger says. “Now as we look at be­gin­ning of 2019, where else can we ap­ply this tech­nol­o­gy?”


Im­age: Steve Brug­ger.

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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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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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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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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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.