Covid-19 man­u­fac­tur­ing roundup: Catal­ent adds freez­er part­ner for vac­cine pro­duc­tion push; In need of vol­un­teers, Lon­za turns to food work­ers

As Catal­ent ramps up its pro­duc­tion of Covid-19 vac­cines in a re­cent push to dou­ble its pro­duc­tion, it has se­cured more of the  tech­nol­o­gy to store them.

Catal­ent and Ster­ling will work to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines. The part­ner­ship has al­ready re­sult­ed in the in­stal­la­tion of over 200 freez­ers at Catal­ent fa­cil­i­ties with plans for an­oth­er 60 to be in­stalled at cell and gene ther­a­py sites across the US, Eu­rope and Asia.

The freez­ers can op­er­ate at tem­per­a­tures as low as -86 de­grees Cel­sius and as high as -20 de­grees Cel­sius.

The freez­ers use 100% nat­ur­al re­frig­er­ants and will pro­duce 30% of the car­bon diox­ide over a 10-year span than a typ­i­cal freez­er would pro­duce, the com­pa­ny said. The Athens, OH-based com­pa­ny al­so claims the in­dus­try’s on­ly portable so­lu­tion for re­mote clin­i­cal tri­als and drug de­liv­ery.

On Thurs­day, Mod­er­na an­nounced that it would ex­pand pro­duc­tion of its mR­NA-based Covid-19 vac­cines at sev­er­al of its fa­cil­i­ties, in­clud­ing Catal­ent’s, in an ef­fort to keep up with virus vari­ants and pro­vide dos­es to coun­tries in need. One of the is­sues it faces is keep­ing the vac­cine cold enough — at least -20 de­grees Cel­sius — while de­liv­er­ing the vac­cines to coun­tries that do not have easy ac­cess to mod­ern re­frig­er­a­tion de­vices.

In need of vol­un­teers, Lon­za turns to food work­ers to help make vac­cine

As a num­ber of com­pa­nies have pledged to ramp up Covid-19 vac­cines fol­low­ing re­cent sec­ond waves around the world, drug­mak­ers are in need of em­ploy­ees to help speed up pro­duc­tion.

In Switzer­land, Lon­za has re­cruit­ed staff from food gi­ant Nes­tle to make in­gre­di­ents, ac­cord­ing to Reuters.

Mod­er­na re­cent­ly an­nounced that it would dou­ble the vac­cine pro­duc­tion at sev­er­al of its plants, and Lon­za’s site in Visp is one of them. Last week, the com­pa­ny blamed de­lays in ship­ments on pro­duc­tion bot­tle­necks. Em­ploy­ees at a west­ern Switzer­land Nes­tle re­search cen­ter were asked a week ago to vol­un­teer to step in­to the vac­cine man­u­fac­tur­ing world for a three-month mis­sion, Reuters said.

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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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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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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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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FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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