FDA halts the use of GSK's Covid-19 drug com­plete­ly as BA.2 sub­vari­ant blan­kets the coun­try

It on­ly took the Omi­cron BA.2 sub­vari­ant three busi­ness days to go from shut­ting down Glax­o­SmithK­line and Vir Biotech­nol­o­gy’s Covid-19 treat­ment sotro­vimab in 22 states, as of last Fri­day, to the FDA com­plete­ly shut­ting off use of the mon­o­clon­al an­ti­body na­tion­wide on Tues­day af­ter­noon.

The de­ci­sion was made as the CDC now es­ti­mates that the pro­por­tion of Covid-19 cas­es caused by BA.2 is above 50% na­tion­wide.

“Sotro­vimab is no longer au­tho­rized to treat COVID-19 in any U.S. re­gion due to in­creas­es in the pro­por­tion of COVID-19 cas­es caused by the Omi­cron BA.2 sub-vari­ant,” the FDA said in a state­ment.

While Omi­cron and its sub­vari­ant haven’t strained the health sys­tem like pre­vi­ous vari­ants, at least so far, they have elim­i­nat­ed the use of sev­er­al key drugs from the US ar­ma­men­tar­i­um of Covid treat­ments.

But GSK and Vir made clear on Tues­day that sotro­vimab is far from done. In ad­di­tion to prepar­ing to sub­mit new da­ta to the FDA to sup­port a high­er dose of sotro­vimab to treat the BA.2 sub­vari­ant, the com­pa­nies are al­so still mov­ing ahead with their plans to sub­mit for a full FDA ap­proval for sotro­vimab in the sec­ond half of this year.

The pair al­so still ex­pect to man­u­fac­ture ap­prox­i­mate­ly 2 mil­lion dos­es in the first half of 2022, and ad­di­tion­al dos­es in the sec­ond half of the year.

They al­so still ex­pect to com­mence two Phase III tri­als this quar­ter, ac­cord­ing to a Vir SEC fil­ing, to as­sess the use of sotro­vimab in un­in­fect­ed im­muno­com­pro­mised pa­tients to de­ter­mine whether sotro­vimab can pre­vent symp­to­matic Covid in­fec­tion.

One tri­al is a plat­form tri­al, and the oth­er is a com­pa­ny-spon­sored tri­al, known as COMET-STAR, al­though the pri­ma­ry end­points for both are the in­ci­dence of symp­to­matic PCR-con­firmed Covid-19. Vir said COMET-STAR re­sults are still ex­pect­ed to come as ear­ly as the sec­ond half of this year, while ini­tial da­ta from the UK’s RE­COV­ERY Tri­al, which is eval­u­at­ing sotro­vimab among pa­tients hos­pi­tal­ized with Covid in the UK, is al­so ex­pect­ed in the sec­ond half of 2022.

But the loss of sotro­vimab right now in the US means the land­scape for Covid-19 treat­ments con­tin­ues to dwin­dle, with Eli Lil­ly’s bebtelovimab serv­ing as the last re­main­ing mAb.

Since last Sep­tem­ber, the US 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. Vir said it ex­pects to rec­og­nize over $1 bil­lion in sotro­vimab col­lab­o­ra­tion rev­enues in the first half of this year.

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).

On the pos­i­tive side: More than $1 bil­lion of bebtelovimab has been ac­quired so far, and ear­ly da­ta sug­gest it will still stand up to BA.2.

On the neg­a­tive side: Con­gress has yet to fi­nal­ize ad­di­tion­al funds for ac­quir­ing more mAbs from Lil­ly, As­traZeneca’s pro­phy­lac­tic mAb, and an­tivi­ral pills from Pfiz­er and Mer­ck to treat Covid-19.

An agree­ment for $10 bil­lion in new funds has been agreed to in prin­ci­ple, but $5 bil­lion of that is like­ly de­vot­ed to pay­ing for the next round of Pfiz­er’s Paxlovid.

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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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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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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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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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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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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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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