Sanofi, Glax­o­SmithK­line hit with a ma­jor de­lay on Covid-19 vac­cine pro­gram as their first jab flops in old­er adults

Hours af­ter Pfiz­er and BioN­Tech won the back­ing of an FDA pan­el for their mR­NA vac­cine, Sanofi and GSK an­nounced that their close­ly watched pro­gram to de­vel­op an ad­ju­vant­ed vac­cine to com­bat Covid-19 had hit a ma­jor set­back.

The com­pa­nies an­nounced ear­ly Fri­day that they were de­lay­ing their de­vel­op­ment pro­gram for an ad­ju­vant­ed re­com­bi­nant pro­tein-based Covid-19 vac­cine af­ter it failed among adults old­er than 49 in the study.

The re­searchers not­ed a “low im­mune re­sponse in old­er adults like­ly due to an in­suf­fi­cient con­cen­tra­tion of the anti­gen.”

The col­lab­o­ra­tors, who had been hop­ing to launch a piv­otal Phase III this month, are now plan­ning a Phase IIb study of a re­vised vac­cine with an im­proved anti­gen for­mu­la­tion. They plan to get that 2-shot study start­ed in Feb­ru­ary, com­par­ing it to an es­tab­lished vac­cine on the mar­ket. The move will force a de­lay on launch­ing sup­plies of the vac­cine from H1 un­til the 4th quar­ter of 2021, at best, af­ter some of­fi­cials in Op­er­a­tion Warp Speed ex­pect to see the end of the pan­dem­ic in the US.

GSK and Sanofi had pro­ject­ed get­ting hun­dreds of mil­lions of dos­es of this vac­cine out to world mar­kets, rep­re­sent­ing a large por­tion of the vac­cine dos­es the world would need to fight the pan­dem­ic. The com­pa­nies had signed a deal to work with the WHO on eq­ui­table dis­tri­b­u­tion of their vac­cine, of­fer­ing hope of a vac­cine among the world’s less af­flu­ent coun­tries. Their vac­cine de­mand­ed a slow­er ap­proach to de­vel­op­ment, but uti­lized what many be­lieved was a more re­li­able tech­nol­o­gy that could de­liv­er vac­cine in bulk around the world. Now, it ap­pears like­ly that Pfiz­er/BioN­Tech and Mod­er­na will get ap­provals in the near term, as As­traZeneca faces ques­tions about the low­er ef­fi­ca­cy it had seen in its late-stage study.

Any set­back like this threat­ens to length­en the time it takes to van­quish the virus as the first ap­proved vac­cines are like­ly to be in short sup­ply for some time. It al­so will ac­cel­er­ate the vir­tu­al rev­o­lu­tion now un­der­way in the vac­cine in­dus­try, as tra­di­tion­al tech makes way for a faster and ev­i­dent­ly more re­li­able mR­NA ap­proach.

Sanofi and GSK, two of the world’s lead­ing vac­cine mak­ers, are stay­ing in the race, even if they’ve fall­en well be­hind the lead­ers.

Thomas Tri­om­phe

“We have iden­ti­fied the path for­ward and re­main con­fi­dent and com­mit­ted to bring­ing a safe and ef­fi­ca­cious COVID-19 vac­cine. Fol­low­ing these re­sults and the lat­est en­cour­ag­ing new pre­clin­i­cal da­ta, we will now work to fur­ther op­ti­mize our can­di­date to achieve this goal,” said Thomas Tri­om­phe, ex­ec­u­tive vice pres­i­dent and head of Sanofi Pas­teur. “No sin­gle phar­ma com­pa­ny can make it alone; the world needs more than one vac­cine to fight the pan­dem­ic.”

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

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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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

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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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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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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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”