Neil King (University of Washington)

Is a 'su­per-sea­son­al' flu vac­cine on the hori­zon? The NIH and UW are tak­ing a shot in­to the clin­ic this April

Sev­er­al biotechs and phar­ma com­pa­nies are look­ing to dis­cov­er a uni­ver­sal flu vac­cine that could pro­tect hu­mans from any strain of the virus, re­gard­less of which is pre­dict­ed to cir­cu­late. But giv­en how many of these ef­forts are like­ly years away at best, are there any in­ter­me­di­ate steps avail­able to bridge that gap?

That’s the ques­tion Uni­ver­si­ty of Wash­ing­ton re­searcher Neil King and a group of NIH sci­en­tists are hop­ing to an­swer. In a new Na­ture pa­per pub­lished Wednes­day, the team was able to demon­strate broad ef­fec­tive­ness in an­i­mal mod­els for a “su­per-sea­son­al” flu vac­cine by dis­play­ing mul­ti­ple flu strains at the same time. And King says it’s start­ing hu­man tri­als at the end of April.

The big idea is in­stead of get­ting dif­fer­ent flu shots every year as the virus mu­tates, one could get pro­tec­tion from one vac­cine for three to five years, King said.

“Even that would be a mas­sive ad­vance,” King told End­points News. “The virus mu­tates a lit­tle bit and you’re still cov­ered. And the next year it mu­tates a lit­tle bit more and you’re still cov­ered.”

The tech­nol­o­gy King used to ac­com­plish this is sim­i­lar to virus-like par­ti­cles, though he says he would not use that term for “very tech­ni­cal rea­sons.” It’s still used in a sim­i­lar fash­ion, how­ev­er, on­ly in­stead of uti­liz­ing a cap­sid that lacks a genome, the group de­signed pro­tein nanopar­ti­cles that can self-as­sem­ble.

Es­sen­tial­ly what you get are two of these nanopar­ti­cles, which sep­a­rate­ly don’t do much. But when you mix them to­geth­er in a test tube, King said, they as­sem­ble them­selves in­to a new mol­e­cule that can func­tion like a VLP. The tech­nol­o­gy is the same that’s be­ing used by Icosavax, though the com­pa­ny was not in­volved in this spe­cif­ic pa­per.

Su­per-sea­son­al flu shots have been at­tempt­ed be­fore, but the un­der­ly­ing twist here is while the in vit­ro as­sem­bly of the nanopar­ti­cles was the same, King and the NIH team man­aged to codis­play mul­ti­ple flu strains on the same nanopar­ti­cle. They man­aged to in­duce broad re­spons­es in mice, fer­rets and non-hu­man pri­mates, hit­ting not just the “head” of the spe­cif­ic strains but al­so the “stem.”

The stem of the virus strain — whose sci­en­tif­ic jar­gon name is hemag­glu­tinin — is what many sci­en­tists have been af­ter for a uni­ver­sal flu shot, King said, as cur­rent flu shots on­ly go for the head. Some ap­proach­es in­volve cut­ting off the head to fo­cus on­ly on the stem, but the nanopar­ti­cle ap­proach man­aged to train the im­mune sys­tem to at­tack both.

“Tra­di­tion­al­ly that’s been very hard. The im­mune sys­tem just doesn’t re­act very strong­ly to the stem,” King said. “But some­thing about putting these hemag­glu­tinins on our nanopar­ti­cles taught the im­mune sys­tem, ‘Hey, give me the head … but al­so go get that stem too.’ And that is what’s pro­vid­ing the pro­tec­tive breadth from these vac­cines.”

On top of that, the group used the same strains cur­rent­ly in com­mer­cial flu shots. That proved a key part in their ef­forts, King said, be­cause it makes a po­ten­tial reg­u­la­to­ry path through the FDA much eas­i­er.

Be­cause their ex­per­i­men­tal vac­cine has al­ready been man­u­fac­tured, the NIH is bar­rel­ing ahead with a Phase I tri­al planned to start next month. By the end of the year, King says the nanopar­ti­cle tech­nol­o­gy will have four vac­cine pro­grams in the clin­ic: the su­per-sea­son­al flu shot, two po­ten­tial Covid-19 vac­cines and a pro­gram for res­pi­ra­to­ry syn­cy­tial virus, or RSV.

But in or­der to ful­ly com­mer­cial­ize the flu shots and take them all the way through piv­otal Phase III stud­ies, King said they still need a phar­ma com­pa­ny to li­cense the pro­gram. There has been ini­tial in­ter­est from at least two com­pa­nies, though King stayed mum on who’s look­ing.

At the end of the day, the su­per-sea­son­al flu shots are still a ways away from their first sales and even longer from re­plac­ing con­ven­tion­al flu vac­cines, which still use tech­nol­o­gy from the 1930s by grow­ing the pre­dict­ed strains in­side chick­en eggs, King said. A tra­di­tion­al time­line pre-Covid-19 might have tak­en 10 years, but now every­thing is up in the air.

“Af­ter what we saw in 2020 with SARS-CoV-2, I don’t know,” King said about a time­line. “It could be faster. But this thing is en­ter­ing Phase I next month, you have to do Phase II, Phase III, these things do take time. So my guess is it would be at least five years, but who re­al­ly knows?”

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.