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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

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.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

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.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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