Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology…

Santa Ana, California–based NKGen Biotech has received FDA clearance to begin a phase 1/2a trial for their “natural killer” cell therapy, SNK01, designed to treat Alzheimer’s Disease. The autologous, non-genetically modified natural killer (NK) cell therapy involves extracting a patient’s own cells through a blood draw, and then processing them to enhance their natural abilities…

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were…

Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants. The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron. The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies…

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2. “Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral…

Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given…

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award. “But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.…

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them. The criteria divide variants into three categories including the following: Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples…

A recent Phase 3 trial found that Lilly’s bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19. The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm.…