J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days af­ter J&J dosed the first par­tic­i­pants of its Phase III EN­SEM­BLE tri­al, the phar­ma gi­ant has de­tailed the ear­ly-stage da­ta that gave them con­fi­dence in a sin­gle-dose reg­i­men.

Test­ing two dose lev­els ei­ther as a sin­gle dose or in a two-dose sched­ule spaced by 56 days in, the sci­en­tists from Janssen, the J&J sub­sidiary de­vel­op­ing its vac­cine, re­port­ed that the low dose in­duced a sim­i­lar im­mune re­sponse as the high dose. The in­ter­im Phase I/IIa re­sults were post­ed in a preprint on medRx­iv.

More im­por­tant­ly:

A sin­gle dose of Ad26.COV2.S elicit­ed strong hu­moral re­spons­es in the vast ma­jor­i­ty of vac­cine re­cip­i­ents. S-bind­ing an­ti­body titers as mea­sured by ELISA, in­creased from base­line to Day 29 post vac­ci­na­tion in 99% of the par­tic­i­pants in co­hort 1a and 100% of the first par­tic­i­pants in co­hort 3, in­de­pen­dent of the vac­cine dose lev­el that was giv­en.

When it comes to neu­tral­iz­ing an­ti­bod­ies, 98% had de­tectable neu­tral­iz­ing an­ti­bod­ies against the wild-type virus af­ter 29 days.

The J&J sci­en­tists made note of the fact all oth­er Covid-19 vac­cines cur­rent­ly in de­vel­op­ment re­quire two dos­es, but every­one who had a neu­tral­iz­ing an­ti­body re­sponse on their can­di­date ob­tained it af­ter a sin­gle dose.

A chal­lenge study they’ve con­duct­ed in mon­keys sup­port this fund­ing, they added: Pre­vi­ous­ly dis­closed pre­clin­i­cal da­ta showed that a sin­gle dose pro­vid­ed com­plete pro­tec­tion against SARS-CoV-2 repli­ca­tion in the lung and near-com­plete pro­tec­tion against vi­ral repli­ca­tion in the nose.”

In­ter­est­ing­ly, the re­sults sug­gest­ed that old­er adults may be less like­ly to ex­pe­ri­ence side ef­fects on the vac­cine.

“Al­though the safe­ty da­ta in this in­ter­im re­port re­main blind­ed, the over­all oc­cur­rence in­de­pen­dent of dose lev­el of so­licit­ed sys­temic AEs of 64% with a 19% fever rate (5% grade 3) in adults aged 18 to 55 (Co­hort 1a and 1b) stands in con­trast to the so­licit­ed sys­temic AEs of 36% with a 4% fever rate (0% grade 3), found in the par­tic­i­pants ≥ 65 years of age,” the re­searchers wrote.

Lever­ag­ing a re­com­bi­nant ver­sion of ade­n­ovirus serotype 26 (Ad26) that can’t repli­cate as the vec­tor, J&J’s Ad26.COV2.S con­sists of a trans­gene cas­sette en­cod­ing a pre­fu­sion sta­bi­lized SARS-CoV-2 spike pro­tein, de­rived from the first clin­i­cal iso­late of the Wuhan strain.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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