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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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