Re­gen­eron’s Covid mAb as a pro­phy­lac­tic in­jec­tion: Re­duced risk of symp­to­matic in­fec­tion by 81%

Re­gen­eron’s mon­o­clon­al an­ti­body cock­tail for Covid-19 con­tin­ues to im­press, this time in a joint tri­al with NIH that found the nor­mal­ly in­fused treat­ment works as a pre­ven­tive sub­cu­ta­neous in­jec­tion.

The tri­al showed that RE­GEN-COV (casiriv­imab with imde­vimab) re­duced the risk of symp­to­matic in­fec­tions by 81% in those who did not have Covid be­fore the tri­al with­in 29 days. There were 11 cas­es in the 753-per­son mAb arm, ver­sus 59 cas­es in the 752-per­son place­bo arm.

Part of the rea­son the up­take of mon­o­clon­al an­ti­bod­ies like Re­gen­eron’s has been slow is be­cause they re­quire time-con­sum­ing in­fu­sions in spe­cial­ized cen­ters. Each of the lead­ing mAb de­vel­op­ers have been seek­ing to speed the in­fu­sion process or fig­ure out ways to ad­min­is­ter a mAb ther­a­py as an in­jec­tion.

“I think the switch to sub­cu­ta­neous ad­min­is­tra­tion is sig­nif­i­cant be­cause it has the po­ten­tial to move use away from in­fu­sion cen­ters and to doc­tor’s of­fices or even in home ad­min­is­tra­tion. This would like­ly have the ef­fect of in­creas­ing use,” Jeff Hen­der­son, an in­fec­tious dis­ease doc­tor at Wash­ing­ton Uni­ver­si­ty in St. Louis and who was not in­volved with the tri­al, told End­points News.

The tri­al re­sults have not been pub­lished yet in a peer-re­viewed jour­nal, but Re­gen­eron said it will share the da­ta with the US FDA and re­quest that the EUA be ex­pand­ed to in­clude pre­ven­tive treat­ment for the ap­pro­pri­ate pop­u­la­tions, us­ing a 1,200 mg sub­cu­ta­neous dose.

“If au­tho­rized, con­ve­nient sub­cu­ta­neous ad­min­is­tra­tion of RE­GEN-COV could help con­trol out­breaks in high-risk set­tings where in­di­vid­u­als have not yet been vac­ci­nat­ed, in­clud­ing in­di­vid­ual house­holds and group liv­ing set­tings,” My­ron Co­hen, who leads the mon­o­clon­al an­ti­body ef­forts for the NIH-spon­sored COVID Pre­ven­tion Net­work, said in a state­ment.

On av­er­age, in­di­vid­u­als treat­ed with RE­GEN-COV in this lat­est tri­al and who ex­pe­ri­enced a symp­to­matic in­fec­tion re­solved their symp­toms in about 1 week, com­pared to about 3 weeks for those on place­bo. “RE­GEN-COV had rapid on­set, with 72% pro­tec­tion against symp­to­matic in­fec­tions in the first week, ris­ing to 93% in sub­se­quent weeks,” the com­pa­ny said.

The mAb cock­tail is cur­rent­ly avail­able un­der an emer­gency use au­tho­riza­tion for those 12 and old­er who aren’t hos­pi­tal­ized and have mild-to-mod­er­ate Covid-19 and are at high risk for pro­gress­ing to se­vere Covid-19 and/or hos­pi­tal­iza­tion. The US gov­ern­ment has spent more than $3 bil­lion to help de­vel­op, man­u­fac­ture and pur­chase about 1.5 mil­lion treat­ment cours­es of Re­gen­eron’s ther­a­peu­tic, which are ex­pect­ed to be de­liv­ered in the first half of this year.

Hen­der­son al­so said that look­ing at all of the da­ta on mon­o­clon­al an­ti­body treat­ments for Covid-19, this re­sult makes sense be­cause the soon­er they can be ad­min­is­tered, gen­er­al­ly, the bet­ter the out­come. “This is what would be ex­pect­ed, but it’s very good,” he said.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Thomas Schall, ChemoCentryx CEO (file photo)

Chemo­Cen­tryx plunges as FDA rais­es ques­tions about rare dis­ease drug ahead of ad­comm

ChemoCentryx’s stock price on Wednesday was cut in half by the release of FDA briefing documents ahead of a Thursday adcomm, raising questions on the company’s clinical data to support avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

ANCA-associated vasculitides (AAV) affect small to medium-size blood vessels that can be fatal in less than a year if left untreated, according to FDA. Only Roche’s Rituxan is currently FDA-approved for the treatment of AAV, while glucocorticoids are approved for the broader indication of vasculitis.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.

Re­gen­eron’s gold­en goose Eylea may stave off biosim­i­lar com­pe­ti­tion un­til 2024 or be­yond

Almost 10 years have passed since its first FDA approval and Regeneron’s macular degeneration injection Eylea continues to pile up sales to the tune of about $5 billion per year, or more than half of Regeneron’s annual revenues.

Those billions are not expected to go anywhere anytime soon thanks to competition, even as Novartis subsidiary Sandoz announced Monday that it’s beginning a Phase III trial for an Eylea biosimilar in 460 patients across 20 countries.