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?”

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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