IGM Biosciences Advances Novel Antibody IGM-6268 Into Clinical Trials for the Treatment and Prevention of COVID-19

– In vitro studies indicate IGM-6268 exhibits potent neutralization activity against the Omicron variant and all other Variants of Concern and Variants of Interest tested –

– IGM-6268 Phase 1 clinical trials advancing in U.S. and South Africa –

Excerpt from the Press Release:

MOUNTAIN VIEW, Calif., Feb. 09, 2022 (GLOBE NEWSWIRE) — IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its progress in two Phase 1 clinical trials evaluating IGM-6268, an anti-SARS-CoV-2 IgM monoclonal antibody, for the treatment and prevention of COVID-19. The first, a Phase 1 clinical trial in the U.S., is a multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics of IGM-6268 administered intranasally in healthy volunteers. The first two dose cohorts of healthy volunteers have been successfully cleared in the U.S., and data from the study are expected in the first half of 2022. The second, a Phase 1a/1b clinical trial in South Africa, is a multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IGM-6268 administered intranasally first in healthy volunteers, once an appropriate dose cohort has been cleared, in outpatients with mild to moderate COVID-19. The first dose cohort of healthy volunteers has been cleared in the South Africa study, and data from the study are expected in mid-2022.

IGM today also announced that results from in vitro pseudovirus testing conducted by a widely recognized, commercial laboratory indicate that IGM-6268 exhibits neutralization of the Omicron (B.1.1.529) variant at an IC₅₀ of 230 ng/mL, as well as potent in vitro neutralization activity against all other SARS-CoV-2 Variants of Concern (VoC) and Variants of Interest (VoI) tested to date, including the Delta variant. This indicated IC₅₀ for the Omicron variant is expected to be well below the concentrations achievable by intranasal administration in key sites of infection and viral replication, based on previous observations from animal studies. These results expand upon data previously published in Nature, in which IGM-6268 exhibited significantly increased potency against wild type SARS-CoV-2 relative to an IgG antibody with the same binding domains and exhibited potent neutralization against the Alpha (B.1.1.7), Gamma (P.1), and Beta (B.1.351) variants, as well as other receptor-binding domain mutants that conferred resistance to several IgG antibodies authorized for emergency use.

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