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?”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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