FDA cuts off use of GSK's Covid treat­ment in al­most half of the US as BA.2 spreads

With the rise of the Omi­cron sis­ter vari­ant BA.2, Glax­o­SmithK­line and Vir Biotech­nol­o­gy’s cru­cial mon­o­clon­al an­ti­body — one of on­ly two mAbs still be­ing shipped by the US gov­ern­ment to states to treat Covid-19 — has fi­nal­ly met its match, and al­most half of all US states have now lost ac­cess to the cru­cial mAb as it’s not as ef­fec­tive against the new strain.

AS­PR on Fri­day said it paused dis­tri­b­u­tion of GSK and Vir’s sotro­vimab to six states across the Mid­west (Illi­nois, In­di­ana, Michi­gan, Min­neso­ta, Ohio and Wis­con­sin), and eight states in the West (Ari­zona, Cal­i­for­nia, Hawaii, Neva­da, Alas­ka, Ida­ho, Ore­gon and Wash­ing­ton), as well as five ter­ri­to­ries — the Com­mon­wealth of the North­ern Mar­i­ana, Guam, Amer­i­can Samoa, Re­pub­lic of Palau and the Re­pub­lic of the Mar­shall Is­lands.

This halt is in ad­di­tion to a pre­vi­ous halt from late last month across the North­east, as AS­PR said sotro­vimab will no longer be used in eight states and two US ter­ri­to­ries.

Sotro­vimab still re­mains au­tho­rized in the US where the CDC es­ti­mate for the pro­por­tion of the BA.2 vari­ant re­mains be­low 50%. FDA says it will con­tin­ue to mon­i­tor BA.2 na­tion­wide and may re­vise the au­tho­riza­tion fur­ther.

“Health care providers in re­gions where sotro­vimab re­mains au­tho­rized should strong­ly con­sid­er the use of oth­er ap­proved or au­tho­rized prod­ucts, and mon­i­tor the fre­quen­cy of BA.2 in their re­gion as they choose ap­pro­pri­ate treat­ment op­tions for pa­tients,” the FDA said on Fri­day.

On top of the loss of sotro­vimab across 22 states, and like­ly more in the near fu­ture, Con­gress has yet to fi­nal­ize ad­di­tion­al funds for ac­quir­ing more mAbs from Eli Lil­ly and As­traZeneca and an­tivi­ral pills from Pfiz­er and Mer­ck to treat Covid-19. An agree­ment for $10 bil­lion in new funds, with $5 bil­lion de­vot­ed to treat­ments, ac­cord­ing to Sen. Roy Blunt (R-MO), is still in the works.

Since last Sep­tem­ber, the US has bought al­most $2 bil­lion worth of sotro­vimab cours­es, ac­cord­ing to BAR­DA, and shipped more than 912,000 cours­es to states (as of Sun­day), ac­cord­ing to the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse. Where­as the oth­er mAb that’s still be­ing shipped to states, Eli Lil­ly’s bebtelovimab, has seen just over 300,000 cours­es shipped, more than $1 bil­lion of the drug has been ac­quired. Ear­ly da­ta sug­gest bebtelovimab will still stand up to BA.2 too, ac­cord­ing to BAR­DA.

Three oth­er mAbs en­tered the grave­yard of Covid-19 treat­ments pre­vi­ous­ly as they were halt­ed due to wan­ing ef­fec­tive­ness against the dom­i­nant strain, in­clud­ing two block­busters from Eli Lil­ly (bam­lanivimab/ete­se­vimab and bam­lanivimab) and one block­buster com­bo mAb from Re­gen­eron (casiriv­imab/imde­vimab).

Re­gen­eron said in an SEC fil­ing re­cent­ly that it has com­plet­ed or dis­con­tin­ued dos­ing with its mAb com­bo in all treat­ment and pre­ven­tion stud­ies. How­ev­er, the com­pa­ny said it con­tin­ues to de­vel­op “next gen” an­ti­bod­ies that are ac­tive against Omi­cron and oth­er vari­ants of con­cern, with new clin­i­cal de­vel­op­ment in the com­ing months.

Mean­while, for those look­ing for Covid-19 treat­ments: AS­PR has now cre­at­ed a web-based site ​lo­ca­tor to make it eas­i­er to find its “Test to Treat” lo­ca­tions, which is a new fed­er­al pro­gram where peo­ple can go to a lo­cal phar­ma­cy, get test­ed for Covid-19, and re­ceive treat­ment on site if the test is pos­i­tive.

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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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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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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