Kelly Ganjei, AmplifyBio CEO

Am­pli­fy­Bio scoops up lab space and oth­er as­sets from PACT Phar­ma as cell ther­a­py biotech read­justs

The West Coast cell ther­a­py biotech PACT Phar­ma was fac­ing some chal­lenges af­ter sev­er­al em­ploy­ees got the axe from the com­pa­ny and ex­ecs put the ki­bosh on its on­ly clin­i­cal tri­al. Now, the com­pa­ny has sold some of its as­sets to an Ohio-based con­tract re­search or­ga­ni­za­tion.

Am­pli­fy­Bio has ac­quired a 46,280 square-foot lab in South San Fran­cis­co, CA, with around 40 em­ploy­ees spe­cial­iz­ing in cell and gene ther­a­py de­vel­op­ment and ac­cess to tech­nol­o­gy plat­forms that can be ap­plied to “prod­uct char­ac­ter­i­za­tion.”

In an in­ter­view with End­points News, Am­pli­fy­Bio CEO J. Kel­ly Gan­jei said that he is bull­ish on ac­quir­ing some of PACT’s as­sets since the com­pa­ny’s goal had been to cre­ate per­son­al­ized ther­a­pies for each pa­tient. That those ca­pa­bil­i­ties come with some of PACT’s team, which has ex­pe­ri­ence in craft­ing hun­dreds of per­son­al­ized prod­ucts, is per­fect for Am­pli­fy­Bio’s line of work.

Gan­jei said that the move gives Am­pli­fy­Bio a team of peo­ple to push more in­to the cell ther­a­py space. The team has ef­fec­tive­ly made hun­dreds of per­son­al­ized ther­a­pies and has deep know-how to char­ac­ter­ize prod­ucts.

“So, we want­ed to en­able our clients to not on­ly be able to know what it is that they’re mak­ing from a phar­ma­co­ki­net­ics per­spec­tive, but al­so re­al­ly fol­low the bi­ol­o­gy of what it is that they’re de­vel­op­ing,” Gan­jei told End­points. “And so, what bet­ter way to do that than to ac­quire the peo­ple and tech­nolo­gies and ca­pa­bil­i­ties sets that PACT has de­vel­oped over time that is high­ly spe­cif­ic to prod­uct char­ac­ter­i­za­tion, very deep im­munol­o­gy ex­pe­ri­ence, and ca­pa­bil­i­ty.”

The ac­qui­si­tion hasn’t bought out PACT out­right, as it will be able to keep some of its in­tel­lec­tu­al prop­er­ty and con­tin­ue its work in the T-cell space, PACT’s CEO Scott Gar­land said in a state­ment.

While no fi­nan­cial de­tails on the deal were dis­closed to End­points, Gan­jei said that the as­sets will be ap­plied to the com­pa­ny al­most im­me­di­ate­ly and have cus­tomers lined up that will use Am­pli­fy­Bio’s char­ac­ter­i­za­tion ser­vices, specif­i­cal­ly for TCR and CAR-T prod­ucts.

Gan­jei al­so said that the com­pa­ny plans to add more em­ploy­ees to its new space in South San Fran­cis­co and sees that head­count dou­bling in the near term, but no ma­jor specifics were dis­closed.

Am­pli­fy­Bio has been on an up­swing this year as the Bat­telle spin­out be­gan to es­tab­lish a new 350,000 square-foot fa­cil­i­ty in the Colum­bus, OH sub­urb of New Al­bany. It al­so pre­vi­ous­ly raised $200 mil­lion and has been fo­cused on safe­ty, ef­fi­ca­cy and tox­i­col­o­gy in test­ing drug can­di­dates.

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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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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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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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

Man­u­fac­tur­ing roundup: Touch­light nets $2M grant from the Gates Foun­da­tion; Ex­per­ic clos­es $14M Se­ries B

The manufacturer of the “Doggybone DNA” synthetic vector has netted deals with big names, the latest of which is a grant from the Bill & Melinda Gates Foundation to help further Touchlight’s “preclinical development” of its vaccine platform.

The vaccine program aims to build on evidence that the synthetic DNA the company produces can produce strong antibodies and durable T cell responses following vaccine administration.

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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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.