Joseph Payne, Arcturus CEO (Arcturus via YouTube)

Arc­turus touts $63M BAR­DA award for new mR­NA in­fluen­za vac­cine, hop­ing to prep against fu­ture pan­demics

A San Diego mR­NA biotech is look­ing to ex­pand its ef­forts in in­fluen­za, and a fed­er­al award will bring it clos­er to that goal.

Arc­turus Ther­a­peu­tics said Wednes­day that it won an award from HHS’s BAR­DA worth $63.2 mil­lion, a grant that was award­ed as part of the en­ti­ty’s pan­dem­ic in­fluen­za ef­forts. The grant will be divvied out over the next three years to boost Arc­turus’ self-am­pli­fy­ing mR­NA vac­cine plat­form tech on mul­ti­ple as­pects, such as pre­clin­i­cal re­search, man­u­fac­tur­ing, non-clin­i­cal safe­ty stud­ies and reg­u­la­to­ry sup­port.

The goal, per an Arc­turus state­ment, is to push a can­di­date for in­fluen­za from pre­clin­i­cal through Phase I clin­i­cal stud­ies.

CEO Joseph Payne tells End­points News that there’s a big dif­fer­ence be­tween sea­son­al in­fluen­za and pan­dem­ic in­fluen­za. One is the kind for which some­one gets their an­nu­al shot, and the oth­er is one that could mu­tate and be­come more of a threat.

“This pan­dem­ic flu is some­thing that is of sig­nif­i­cant con­cern for the Unit­ed States gov­ern­ment, be­cause it could be very lethal — far more lethal than Covid ever was,” Payne added.

The CEO not­ed that there’s in­creased en­er­gy in the US and around the world to be more proac­tive on pan­dem­ic pre­pared­ness, and right now there’s a fo­cus on pan­dem­ic flu.

In the mean­time, the next im­me­di­ate step for Arc­turus is to start pre­clin­i­cal re­search.

“We’re go­ing to be work­ing with the Unit­ed States gov­ern­ment to make sure that we’re go­ing af­ter the strains that are of most con­cern in the pan­dem­ic flu space,” Payne said.

Arc­turus’ vac­cine de­sign, ac­cord­ing to Payne, hinges on its abil­i­ty to be self-am­pli­fy­ing, es­sen­tial­ly the abil­i­ty to ex­press an anti­gen for a week or two once it en­ters a cell, in­stead of one or two days. The CEO not­ed that it would al­low the vac­cine dose to be no big­ger than five µg, a sub­stan­tial dif­fer­ence com­pared to re­cent mR­NA boost­ers at 30 or 50 µg.

On top of that, the fi­nal prod­uct that the com­pa­ny hopes to de­liv­er to BAR­DA would by lyophilized, or freeze-dried, and would al­low for po­ten­tial­ly mul­ti-year stor­age in the na­tion­al strate­gic stock­pile.

The biotech pre­vi­ous­ly had shared re­sults from a “Phase I/II/III study” in late April from its lead can­di­date, a Covid-19 mR­NA vac­cine. While it was 55% ef­fec­tive at stop­ping symp­to­matic Covid-19 in­fec­tion and 95% ef­fec­tive at pre­vent­ing se­vere dis­ease, the da­ta came out af­ter more than a third of Amer­i­cans had al­ready got­ten their first boost­er. In­vestors sent the stock price $ARCT down 15%.

Fast for­ward to to­day, where the stock price is up 2% as of Thurs­day morn­ing.

BAR­DA, for its part, has been busy in re­cent months. On top of mul­ti­ple or­ders of Bavar­i­an Nordic’s mon­key­pox vac­cine Jyn­neos, the of­fice gave out $11 mil­lion to Grand Riv­er Asep­tic Man­u­fac­tur­ing ear­li­er this week, which had agreed to pro­vide fill and fin­ish ser­vices for Bavar­i­an Nordic’s vac­cine.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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