Covid-19 roundup: Sh­iono­gi’s an­tivi­ral pill hits the mark; Ocu­gen strikes deal for in­tranasal vac­cine

Japan­ese phar­ma Sh­iono­gi’s Covid-19 an­tivi­ral against Omi­cron passed its Phase III tri­al in Asia, meet­ing its pri­ma­ry end­point.

The drug, a pro­tease in­hibitor known as en­sitrelvir, was ad­min­is­tered dai­ly for five days and led to a sig­nif­i­cant re­duc­tion in symp­toms such as stuffy or run­ny nose, sore throat, cough, feel­ing hot or fever­ish, and low en­er­gy or tired­ness with­in 72 hours of its on­set, the com­pa­ny an­nounced Wednes­day. A to­tal of 1,821 most­ly vac­ci­nat­ed pa­tients from Japan, South Ko­rea and Viet­nam were en­rolled in the study.

The me­di­an time for pa­tients to ex­pe­ri­ence re­lief in five Covid-19 symp­toms was sig­nif­i­cant­ly re­duced in the co­hort that was treat­ed with the low dose of en­sitrelvir (the dose lev­el sub­mit­ted for ap­proval in Japan) com­pared to place­bo: 167.9 hours ver­sus 192.2. No sig­nif­i­cant ad­verse ef­fects were not­ed, the com­pa­ny said.

Mean­while, the study al­so hit its sec­ondary end­point — re­duc­tion in vi­ral RNA on day 4 — fol­low­ing the third dose.

The com­pa­ny has sub­mit­ted the topline re­sults of the Phase III tri­al to Japan­ese drug reg­u­la­tors for re­view. Pre­vi­ous­ly, the reg­u­la­to­ry au­thor­i­ties in Japan de­nied emer­gency ap­proval for use of the pill, and asked for more da­ta on its ef­fec­tive­ness, Reuters re­port­ed.

If ap­proved, Sh­iono­gi’s drug could face stiff com­pe­ti­tion with Covid-19 pills from Pfiz­er and Mer­ck’s Covid-19 an­tivi­rals that have al­ready been ap­proved in Japan and in oth­er coun­tries.

Ocu­gen en­ters a deal to com­mer­cial­ize a ‘uni­ver­sal’ in­tranasal covid vac­cine

Penn­syl­va­nia-based Ocu­gen wants to com­mer­cial­ize an in­tranasal­ly de­liv­ered Covid-19 vac­cine in the US, Eu­rope, and Japan.

The com­pa­ny has en­tered a li­cens­ing deal with Wash­ing­ton Uni­ver­si­ty in St. Louis, which de­vel­oped the vac­cine along with In­di­an phar­ma­ceu­ti­cal Bharat Biotech. Ocu­gen claims that the in­tranasal shot could be ef­fec­tive against all vari­ants of Covid-19. This vac­cine is al­ready au­tho­rized for emer­gency use in In­dia, the com­pa­ny said.

“As the ef­fort to end the pan­dem­ic fo­cus­es on ef­fec­tive boost­er op­tions, Ocu­gen is ex­cit­ed about the po­ten­tial for this vac­cine to be a uni­ver­sal boost­er, re­gard­less of pre­vi­ous COVID-19 vac­ci­na­tion his­to­ry,” the com­pa­ny added in a press re­lease.

The vac­cine con­tains spike pro­tein of the SARS-CoV-2 virus, pack­aged in an ade­n­ovirus vec­tor.

Ac­cord­ing to the com­pa­ny, de­liv­er­ing the vac­cine through the nasal route cre­ates strong im­mu­ni­ty against the virus in the nose, mouth, up­per air­ways and lungs, where the virus tends to in­fect the most.

“Be­cause the vac­cine can be de­liv­ered di­rect­ly in­to the nose, it is specif­i­cal­ly de­signed to block in­fec­tion at the por­tal of virus en­try, and we be­lieve it may help pre­vent trans­mis­sion as well as pro­vide pro­tec­tion against new COVID-19 vari­ants,” said Michael Di­a­mond, in­ven­tor of the nasal vac­cine tech­nol­o­gy.

Re­vive’s Covid pill finds a stop sign at the FDA’s doorsteps

Re­vive Ther­a­peu­tics has hit a hilly road with its oral Covid-19 drug.

The FDA has re­ject­ed the pri­ma­ry end­point for the Phase III study of the com­pa­ny’s an­tivi­ral drug bu­cil­lamine. Re­vive is cur­rent­ly study­ing the drug’s an­ti-in­flam­ma­to­ry and an­tivi­ral prop­er­ties in pa­tients with mild to mod­er­ate Covid-19.

Reg­u­la­tors, how­ev­er, have asked the com­pa­ny to sub­mit a meet­ing re­quest to dis­cuss the “ap­pro­pri­ate end­points and jus­ti­fi­ca­tion of the rel­e­vance of the re­vised pri­ma­ry end­point,” the com­pa­ny said in a press re­lease.

Mean­while, the com­pa­ny has de­cid­ed to con­tin­ue with and re­view post-dose se­lec­tion da­ta in around 500 pa­tients.

“Re­gard­less of the out­come, the Com­pa­ny would pro­ceed to seek a meet­ing with the FDA to agree on a pro­posed plan for po­ten­tial reg­u­la­to­ry ap­proval,” Re­vive said in a press state­ment.

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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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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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.