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.

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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