Covid-19 roundup: Swiss biotech halts in-pa­tient PhII study; Hous­ton-based vac­cine and Chi­nese mR­NA shot nab EUAs in In­done­sia

An­oth­er Covid-19 study is hit­ting the brakes as a Swiss biotech is paus­ing its Phase II tri­al in pa­tients hos­pi­tal­ized with Covid-19.

Ki­narus Ther­a­peu­tics an­nounced on Fri­day that the Da­ta and Safe­ty Mon­i­tor­ing Board (DSMB) has re­viewed the com­pa­ny’s Phase II study for its can­di­date KIN001 and has rec­om­mend­ed that the study be stopped.

Ac­cord­ing to Ki­narus, the DSMB stat­ed that there was a low prob­a­bil­i­ty to show sta­tis­ti­cal­ly sig­nif­i­cant re­sults as the num­ber of Covid-19 pa­tients that are in the hos­pi­tal is low­er than at oth­er points in the pan­dem­ic.

Thier­ry Fumeaux

“As many of our peers have learned since the be­gin­ning of the pan­dem­ic, it has be­come chal­leng­ing to show the im­pact of ther­a­peu­tic in­ter­ven­tion at the cur­rent pan­dem­ic stage, giv­en the dis­ease char­ac­ter­is­tics in Covid-19 pa­tients with se­vere dis­ease. More­over, there are al­so now rel­a­tive­ly small­er num­bers of pa­tients that meet en­roll­ment cri­te­ria, since few­er pa­tients re­quire hos­pi­tal­iza­tion, in con­trast to the sit­u­a­tion ear­li­er in the pan­dem­ic,” said Thier­ry Fumeaux, Ki­narus CMO, in a state­ment.

Fumeaux con­tin­ued to state that the drug will still be in­ves­ti­gat­ed in am­bu­la­to­ry Covid-19 pa­tients who are not hos­pi­tal­ized, with the goal of re­duc­ing re­cov­ery time and the sever­i­ty of the virus.

The KIN001 can­di­date is a com­bi­na­tion of the small mol­e­cule in­hibitor pamapi­mod and pi­ogli­ta­zone, which is cur­rent­ly used to treat type 2 di­a­betes.

The news has put a damper on the com­pa­ny’s stock price $KNRS.SW, which is down 22% since open­ing on Fri­day.

Hous­ton-de­vel­oped vac­cine and Chi­nese mR­NA shot win EUAs in In­done­sia

While Mod­er­na and Pfiz­er/BioN­Tech’s mR­NA shots to counter Covid-19 have dom­i­nat­ed sup­plies world­wide, a Chi­nese-based mR­NA de­vel­op­er and In­doVac, a re­com­bi­nant pro­tein-based vac­cine, was cre­at­ed and en­gi­neered in Hous­ton by the Texas Chil­dren’s Hos­pi­tal Cen­ter for Vac­cine De­vel­op­ment. And the vac­cine is fi­nal­ly ready to head to an­oth­er na­tion.

Wal­vax and Suzhou Abo­gen’s mR­NA vac­cine, dubbed AW­cor­na, has been ap­proved for emer­gency use for adults 18 and over by the In­done­sian Food and Drug Au­thor­i­ty.

Li Yunchun

“This is the first step, and we are hop­ing to see more fam­i­lies across the coun­try and the rest of the globe pro­tect­ed, which is a shared goal for us all,” said Wal­vax chair­man Li Yunchun in a state­ment.

Ac­cord­ing to Wal­vax, the vac­cine is 83% ef­fec­tive against the “wild-type” of SARS-CoV-2 in­fec­tion with the strength against the Omi­cron vari­ants stand­ing at around 71%. The shots are al­so not re­quired to be stored in deep freeze con­di­tions and can be put in stor­age at 2 to 8 de­grees Cel­sius.

Wal­vax and Abo­gen have been mak­ing progress on their mR­NA vac­cine for a while. Last year, Abo­gen re­ceived a mas­sive amount of fund­ing as it was mov­ing the can­di­date for­ward.

How­ev­er, while the can­di­date is mov­ing for­ward over­seas, it’s still find­ing it­self stuck in reg­u­la­to­ry ap­proval in Chi­na. Ac­cord­ing to a re­port from BNN Bloomberg, Chi­na has not ap­proved any mR­NA vac­cines for do­mes­tic us­age.

Mean­while, PT Bio Far­ma, the hold­ing com­pa­ny for state-owned phar­ma com­pa­nies in In­done­sia, is prep­ping to make 20 mil­lion dos­es of the In­doVac Covid-19 vac­cine this year and 100 mil­lion dos­es by 2024.

In­doVac’s pri­ma­ry se­ries vac­cines in­clude near­ly 80% of lo­cal­ly sourced con­tent. In­done­sia is seek­ing Ha­lal Cer­ti­fi­ca­tion for the vac­cine since no an­i­mal cells or prod­ucts were used in the pro­duc­tion of the vac­cine. In­doVac suc­cess­ful­ly com­plet­ed an au­dit from the In­done­sian Ule­ma Coun­cil Food and Drug Analy­sis Agency, and the Ha­lal Cer­ti­fi­ca­tion Agency of the Re­li­gious Af­fairs Min­istry is ex­pect­ed to grant their ap­proval soon.

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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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

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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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

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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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.