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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Clay Siegall (Life Science Washington via YouTube)

#ES­MO20: Seat­tle Ge­net­ics eyes 4th ap­proval with new da­ta in a crowd­ed field

Does Seattle Genetics have another approval on its hands?

The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion deal with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval.

Jonathan Rigby, Immune Regulation group CEO

Im­mune Reg­u­la­tion, tak­ing two clin­i­cal pro­grams to 're­set' the im­mune sys­tem, nets $53M+ Se­ries B

A little under two years after a company rebranding, Immune Regulation is taking an even bigger step toward advancing its goals.

Formerly known as Peptinnovate, the British biotech announced a $53.4 million Series B early Monday morning, helping to further advance two clinical programs in rheumatoid arthritis and asthma. Though those are the two initial indications the company is focusing on, CEO Jonathan Rigby told Endpoints News he hopes the candidates can be applied to a broad swath of autoimmune disorders.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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