Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Sanofi lands 3rd Covid-19 vac­cine man­u­fac­tur­ing part­ner as it works to push for­ward its own jab

As the de­mand for mR­NA-based Covid-19 vac­cines per­sists, Sanofi is jump­ing in­to the fray.

The French drug­mak­er has en­tered an agree­ment with Mod­er­na to man­u­fac­ture the com­pa­ny’s Covid-19 vac­cine. The agree­ment marks the third dif­fer­ent com­pa­ny Sanofi has paired with to man­u­fac­ture a Covid-19 vac­cine, since their own ef­fort to de­vel­op a pan­dem­ic in­oc­u­la­tion faced sig­nif­i­cant set­backs.

The com­pa­ny will per­form fill-and-fin­ish at its Ridge­field, NJ site to com­plete up to 200 mil­lion dos­es of the vac­cine. That will be­gin in Sep­tem­ber.

“Since the be­gin­ning of the pan­dem­ic, we have been mo­bi­liz­ing on mul­ti­ple fronts and we showed sol­i­dar­i­ty across the in­dus­try,” CEO Paul Hud­son said in a state­ment. “We are one of the few phar­ma­ceu­ti­cal com­pa­nies to lever­age many in­dus­tri­al part­ner­ships to im­prove eq­ui­table glob­al sup­ply and ac­cess to Covid-19 vac­cines, while in par­al­lel, al­so con­tin­u­ing to de­vel­op our 2 Covid-19 vac­cine pro­grams.”

In Feb­ru­ary, Sanofi an­nounced that it would sup­port man­u­fac­tur­ing for 12 mil­lion dos­es a month of J&J’s vac­cine at its man­u­fac­tur­ing site in France. Be­fore that, the com­pa­ny signed on to pro­vide 125 mil­lion dos­es of the Pfiz­er-BioN­Tech vac­cine for the EU, step­ping up as some coun­tries wor­ried if they’d re­ceive enough dos­es and Italy threat­ened le­gal ac­tion.

Its own at­tempt at a Covid-19 vac­cine, along­side Glax­o­SmithK­line, hit a ma­jor set­back in De­cem­ber, af­ter the com­pa­nies an­nounced the shot failed among adults old­er than 49 years old in an ear­ly study. A low im­mune re­sponse “like­ly due to suf­fi­cient con­cen­tra­tion of the anti­gen” was to blame, ac­cord­ing to re­searchers. The 2 com­pa­nies had an­tic­i­pat­ed get­ting hun­dreds of mil­lions of the vac­cine on the mar­ket to help parts of the world in dire need of pan­dem­ic help, and re­lied on a slow­er but more proven tech­nol­o­gy.

That vac­cine can­di­date us­es the same re­com­bi­nant pro­tein-based tech­nol­o­gy as 1 of the com­pa­ny’s sea­son­al flu vac­cines. In Feb­ru­ary, Sanofi an­nounced the start of a Phase II study with an im­proved anti­gen fo­mu­la­tion, and a to­tal of 720 par­tic­i­pants. The ear­li­est that vac­cine would be avail­able would be Q4 2021. It pre­vi­ous­ly was look­ing to head to Phase III tri­als in De­cem­ber 2020.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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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.

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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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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