In the race for some­thing — any­thing — to rein in the pan­dem­ic, Cell­tri­on says it will be­gin mass-pro­duc­ing its po­ten­tial Covid-19 an­ti­body treat­ment this month. The In­cheon, South Ko­rea-based com­pa­ny hopes to snag emer­gency ap­proval short­ly there­after.

The drug has gone through a Phase I tri­al with 32 vol­un­teers in South Ko­rea, and will be test­ed in 9 more pa­tients in an­oth­er Phase I study be­fore ad­vanc­ing to lat­er-stage tri­als, per a Reuters re­port. The biotech says it’s go­ing to reg­u­la­tors for emer­gency ap­proval soon — but could pro­duce about 1 mil­lion dos­es be­fore even get­ting the green light.

Cell­tri­on got ap­proval to con­duct a sep­a­rate Phase I tri­al in the UK back in Ju­ly, and it’s plan­ning glob­al Phase II and III stud­ies.

“Our hu­man tri­als are con­duct­ed glob­al­ly, so we will be able to ex­port for sure, but will of­fer it to pa­tients abroad on­ly af­ter se­cur­ing do­mes­tic sup­plies for South Ko­rea,” CEO Kee Woo-Sung told Reuters in Ju­ly.

The can­di­date is de­signed to neu­tral­ize the D614G vari­ant of Covid-19, which is as­so­ci­at­ed with vi­ral trans­mis­sion. The Ko­rea Cen­ters for Dis­ease Con­trol and Pre­ven­tion (KCDC) gave Cell­tri­on a nod to be­gin de­vel­op­ing the an­ti­body in March, when cas­es there were spik­ing.

Cell­tri­on hopes it can de­vel­op a “su­per an­ti­body,” which could neu­tral­ize not on­ly SARS-CoV-2, but al­so re­lat­ed strains.

Its can­di­date is one of sev­er­al an­ti­body treat­ments in de­vel­op­ment world­wide, in­clud­ing Re­gen­eron’s REGN10933 and REGN10987, which tar­get the spike pro­tein at dif­fer­ent, non-over­lap­ping lo­ca­tions. The cock­tail en­tered Phase II/III test­ing in Ju­ly, and ac­cord­ing to ear­ly da­ta, re­duced dam­age to the lungs and cas­es of pneu­mo­nia in mon­keys com­pared to a place­bo.

Eli Lil­ly ini­ti­at­ed a Phase III tri­al of its an­ti­body ther­a­py in ear­ly Au­gust. The study will take place across long-term care fa­cil­i­ties in the US, and could en­roll up to 2,400 pa­tients.

In an ear­ly clin­i­cal tri­al, pa­tients on Hu­mani­gen and Catal­ent Bi­o­log­ics’ lenzilum­ab had a me­di­an time to re­cov­ery and dis­charge of five days, ac­cord­ing to the com­pa­nies. In Au­gust, they got the OK to ex­pand a Phase III study of the mon­o­clon­al an­ti­body to Brazil.

“We may have missed a win­dow to scale the man­u­fac­tur­ing of an­ti­body drugs that could have been an im­por­tant bridge to a vac­cine and a hedge in the event vac­cines are de­layed or don’t work,” for­mer FDA com­mis­sion­er Scott Got­tlieb told STAT last month. “These drugs had the abil­i­ty to per­haps mean­ing­ful­ly change the con­tours of this epi­dem­ic, and we just won’t have enough dos­es to re­al­ize that goal.”

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

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.