Kee Woo-Sung, Celltrion

Cell­tri­on to be­gin mass pro­duc­ing an­ti­body treat­ment be­fore get­ting ap­proval

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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

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.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

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.”

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

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.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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