Biotech part­ner drops Glax­o­SmithK­line’s ad­ju­vant as it moves Covid-19 vac­cine in­to PhII/III, cit­ing ‘man­u­fac­tur­ing con­sid­er­a­tions’

When Glax­o­SmithK­line re­vealed that its Sanofi-part­nered re­com­bi­nant pro­tein-based Covid-19 vac­cine pro­gram was run­ning in­to a ma­jor de­lay, the phar­ma gi­ant tucked in a para­graph not­ing the oth­er low­er-pro­file col­lab­o­ra­tions it had go­ing on that uti­lized its pan­dem­ic ad­ju­vant.

One of those part­ner­ships, though, is now com­ing to an end.

Chi­na’s Clover Bio­phar­ma­ceu­ti­cals — the first biotech to take up GSK’s of­fer to test its ad­ju­vant sys­tem with vac­cine can­di­dates back in Feb­ru­ary — said it’s go­ing to en­ter Phase II/III with an ad­ju­vant from Dy­navax in­stead.

In­ter­est­ing­ly, Phase I re­sults pub­lished just hours be­fore­hand sug­gest that the GSK ad­ju­vant, dubbed AS03, in­duced high im­mune re­spons­es and an­ti­body lev­els, with “lit­tle mean­ing­ful dif­fer­ence” be­tween younger and old­er adults. Dy­navax’s CpG/Alum, by com­par­i­son, kicked up low­er im­mune re­spons­es that were dose de­pen­dent — and old­er vol­un­teers had a weak­er re­sponse.

Al­though the AS03 for­mu­la­tion was al­so tied to more side ef­fects, they were tran­sient and the “re­ac­to­genic­i­ty pro­file com­pares favourably with those of the mR­NA SARS-CoV-2 vac­cine.”

The in­ves­ti­ga­tors’ con­clu­sion, post­ed on The Lancet:

Based on these re­sults, 9 μg SCB-2019 ad­ju­vant­ed with AS03 and 30 μg SCB-2019 ad­ju­vant­ed with CpG/Alum are the pre­ferred can­di­dates to be tak­en in­to the phase 2/3 tri­al; the fi­nal se­lec­tion will be de­ter­mined by man­u­fac­tur­ing con­sid­er­a­tions.

Joshua Liang

Clover didn’t spec­i­fy the con­cerns, but said in a state­ment that the com­pa­nies still have the com­mon goal of max­i­miz­ing their con­tri­bu­tions to end­ing the pan­dem­ic. The hope, CEO Joshua Liang added, is that they will of­fer a vac­cine op­tion with a dif­fer­en­ti­at­ed safe­ty pro­file.

CEPI, which fund­ed the first-in-hu­man study, will con­tin­ue to fi­nance the rest of the clin­i­cal pro­gram.

“To end the acute phase of this pan­dem­ic, and to con­trol the virus in the longer term, the world needs mul­ti­ple safe and ef­fec­tive vac­cines which can be de­ployed in a range of pop­u­la­tions and coun­tries,” said CEPI chief Richard Hatch­ett. “Clover’s vac­cine can­di­date has the po­ten­tial to be man­u­fac­tured at scale and stored in a reg­u­lar re­frig­er­a­tor which makes it suit­able for use around the globe, in­clud­ing in low-re­source set­tings. Through this part­ner­ship we hope to make hun­dreds of mil­lions of dos­es of this vac­cine glob­al­ly ac­ces­si­ble through CO­V­AX, if it is proven to be safe and ef­fec­tive.”

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.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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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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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Immunocore CEO Bahija Jallal (L) and Gadeta CEO Marcel Zwaal

In search for a 'u­ni­ver­sal T cell en­gager', Im­muno­core inks deal with Gilead-backed Gade­ta

Immunocore, which became the first company to win approval for a TCR therapy earlier this year, has penned a deal with gamma delta T cell specialist Gadeta to develop treatments for solid tumors, starting with colorectal cancer.

Immunocore R&D head David Berman told Endpoints News the deal is part of the company’s efforts to develop a “universal T cell engager.” TCR therapies made from typical T cells, like Immunocore’s TCR therapy Kimmtrak, are restricted to patients with certain HLA types, a kind of marker that helps the body separate friend and foe. Kimmtrak, for instance, is indicated only for patients with unresectable or metastatic uveal melanoma, a rare form of cancer that happens in the eye, who have the tissue type HLA-A*02:01, one of the more common HLA types which by Berman’s estimate includes around 40-50% of the population.