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.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.