IGM Biosciences Inc. (NASDAQ: IGM) has announced progress in two Phase I clinical studies evaluating an anti-SARS-CoV-2 IgM monoclonal antibody, IGM-6268, for prevention and treatment of COVID-19.
US cleared the first two dose cohorts of the study
The first is a multi-centre, double-blinded, randomized, placebo-controlled multiple (MAD) and single (SAD) ascending dose trial in healthy subjects to examine the pharmacokinetics, tolerability and safety of IGM-6268 delivered intranasally. The study’s first two dose groups of healthy subjects were cleared in the United States, and results are anticipated in the 1H 2022.
Also, the second trial, a Phase 1a/1b clinical study in South Africa, will be a multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the pharmacokinetics, tolerability, safety, and preliminary effectiveness of IGM-6268 delivered intranasally first in healthy subjects, then in outpatients with mild-to-moderate COVID-19 when a suitable dose cohort has been cleared. The first dose batch of healthy subjects has been approved in the South African study, and results are anticipated in mid-2022.
IGM-6268 is effective against variants of concern
The company also announced that findings from in vitro pseudovirus test conducted by a well-known commercial lab show that IGM-6268 has effective in vitro neutralization action against most SARS-CoV-2 Variants of Interest and Variants of Concern evaluated to date, such as the Delta variant, with an IC50 of 230 ng/mL. Based on earlier animal investigations, the suggested IC50 for the Omicron version is likely to be considerably below the quantities achievable by intranasal delivery in important infection and viral reproduction areas. The findings add to previous research published in Nature that established IGM-6268 was effective against wild type SARS-CoV-2.
Chief Medical Officer Chris Takimoto stated, “IgM antibodies are the first antibodies produced by the immune system when a virus attacks, and they demonstrate very high avidity, or overall binding strength, against the viral antigens they target. Our in vitro neutralization data suggest that engineered IgM antibodies, because of their inherently enhanced avidity and engineered specificity, offer resilience against the emergence of resistant variants of SARS-CoV-2, while demonstrating superior potency over an IgG antibody with the same binding domains.”
