Vir CEO George Scangos (L) and chief corporate affairs officer Bolyn Hubby

In post-Covid life, Vir looks to stomp out in­fluen­za in up to $1B BAR­DA con­tract that boosts GSK-al­lied mAb

With its Covid-19 mon­o­clon­al an­ti­body side­lined in the US since April and plans for full ap­proval no longer in the cards, Vir Biotech­nol­o­gy is putting more eggs in­to the in­fluen­za bas­ket with a hefty-sized con­tract from the fed­er­al gov­ern­ment.

A cap­i­tal in­fu­sion will bankroll a US-on­ly Phase II test­ing Vir’s mAb as a pre-ex­po­sure pro­phy­lax­is to safe­guard against sea­son­al and pan­dem­ic flu. The safe­ty, ef­fi­ca­cy and tol­er­a­bil­i­ty tri­al will kick off lat­er this fall and read out ini­tial da­ta around next sum­mer.

HHS’ BAR­DA has in­ject­ed $55 mil­lion in­to the San Fran­cis­co biotech’s as­set, dubbed VIR-2482, and could dole out a to­tal of $1 bil­lion across that pro­gram and oth­ers, Vir said Tues­day morn­ing.

As part of the mul­ti-year con­tract, Vir could be on tap to cre­ate as many as 10 can­di­dates — whether mAbs or oth­er modal­i­ties — for emerg­ing in­fec­tious dis­ease or Chem­i­cal, Bi­o­log­i­cal, Ra­di­o­log­i­cal, and Nu­clear (CBRN) med­ical coun­ter­mea­sures. The fed­er­al gov­ern­ment con­coct­ed a 12-op­tion agree­ment with the biotech, which has an am­bi­tious mis­sion of “a world with­out in­fec­tious dis­ease.”

“This con­ver­sa­tion start­ed sev­er­al years ago and has gone through a cou­ple gen­er­a­tions. Covid, in the mid­dle, slowed every­body down in terms of think­ing about oth­er av­enues of pre­pared­ness that we need to be ready for,” Bolyn Hub­by, Vir’s chief cor­po­rate af­fairs of­fi­cer, told End­points News in a pre­view of the deal, “and so re­al­ly ex­cit­ed to see BAR­DA come back around as soon as Covid start­ed get­ting more un­der con­trol and add an­ti­bod­ies for pro­phy­lax­is to their agen­da, and this is one of the first awards in that space.”

Vac­cines have long been the pri­ma­ry ap­proach to pre­ven­tion for the flu, as is the av­enue be­ing tak­en by Vir’s coun­ter­parts in the fight against Covid, name­ly BioN­Tech-Pfiz­er and Mod­er­na, both with in­fluen­za vac­cines in late-stage test­ing.

Through a 2021 tie-up, Vir’s sotro­vimab part­ner, GSK, can buy the keys to ex­clu­sive­ly test the mAb in Phase III and com­mer­cial­ize the drug, should it win ap­proval. The mAb was ini­tial­ly con­ceived in Vir’s Bellinzona, Switzer­land labs, Hub­by said. The on­go­ing work is a col­lab­o­ra­tion among the Swiss, Port­land, St. Louis and San Fran­cis­co teams.

In a press re­lease not­ing coro­n­avirus’ last­ing re­minder that in­fec­tious dis­eases pose an “ever-present glob­al threat,” Raj Gup­ta, Vir VP of glob­al health and pub­lic-pri­vate part­ner­ships, made a point of say­ing the biotech be­lieves its Covid-19 as­set, sotro­vimab, “con­tin­ues to bring ben­e­fit to ap­pro­pri­ate pa­tients around the world.” Gup­ta al­so high­light­ed Vir’s pri­or work co-dis­cov­er­ing an­su­vimab for Ebo­la.

The biotech po­si­tions its BAR­DA-fund­ed as­set as an in­tra­mus­cu­lar­ly ad­min­is­tered mAb that goes af­ter all strains of in­fluen­za A ob­served since the 1918 pan­dem­ic.

Vir thinks the sin­gle-dose flu-fight­ing tool might last the en­tire flu sea­son and drum up bet­ter pro­tec­tion than cur­rent vac­cines, which need buy-in from an in­di­vid­ual’s im­mune sys­tem to form the an­ti­bod­ies.

“Vac­cine ef­fi­ca­cy in flu, there’s some room for im­prove­ment. I think it’s an av­er­age ef­fi­ca­cy of about 40% and low­er than that in high-risk pop­u­la­tion – el­der­ly or el­der­ly with co­mor­bidi­ties, im­muno­com­pro­mised — so these are mil­lions and mil­lions of peo­ple that don’t have an op­ti­mal op­tion,” Hub­by said.

Hub­by is fa­mil­iar with the world of flu vac­cines — pri­or to join­ing Vir via its con­sump­tion of gene-edit­ing shop Agen­ovir in 2018, she was VP of vac­cines and an­timi­cro­bials at Syn­thet­ic Ge­nomics, now known as Viri­dos.

Else­where in the pipeline, Vir is in the midst of clin­i­cal stud­ies of po­ten­tial HBV treat­ments with the help of Al­ny­lam, Brii Bio­sciences and Gilead. The biotech, which last month cel­e­brat­ed the open­ing of its St. Louis re­search cam­pus, is in the pre­clin­i­cal stages on an HDV treat­ment. With the help of the Bill & Melin­da Gates Foun­da­tion, Vir is al­so in­ves­ti­gat­ing a T cell vac­cine for HIV, cur­rent­ly in Phase I.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Charles Riv­er se­cures $50M ac­qui­si­tion of drug dis­cov­ery tech com­pa­ny

Over the past several years, Massachusetts-based contractor Charles River Laboratories has been busy on the M&A front, with the latest, $50 million buyout coming Monday for a provider of high-throughput screening solutions for discovery research.

Chicago-based SAMDI Tech will now be folded into Charles River’s discovery and safety assessment division, Charles River announced.

The $50 million in cash is for the 80% of SAMDI that Charles River didn’t previously own. Other financial details on the deal were not disclosed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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