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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.