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?”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.