IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-7354 in Solid Tumors

– Targeted IL-15/IL-15R IgM antibody to be evaluated for safety and pharmacodynamic effects –

MOUNTAIN VIEW, CA, USA I January 17, 2023 I IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-7354, a targeted IL-15/IL-15R IgM antibody which could potentially be used for the treatment of patients with solid and hematologic malignancies.

The multicenter, open-label, dose escalation Phase 1 clinical trial will evaluate IGM-7354 intravenously administered as a monotherapy in patients with relapsed and/or refractory solid tumor cancers. The key objectives of this trial are to provide an initial assessment of pharmacokinetics, safety and immune cell proliferation. If IGM-7354 shows an encouraging safety profile and significant increases in T cells and natural killer (NK) cells in this clinical trial, the Company may begin combination studies of IGM-7354 with T cell engaging antibodies in 2024. The Company may also decide to pursue combination studies with CAR-T or CAR-NK cells with a partner.   

“The initiation of this clinical trial is another significant milestone in IGM’s development, as it is the first clinical study of an IgM targeted immune cytokine,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “If IGM-7354 shows an encouraging safety profile and significant increases in T cells and NK cells, we believe it may have clinical application in treating cancer in combination with a broad range of oncology drugs that rely on those immune cells for efficacy.”

About IGM-7354
IGM-7354 is a targeted IL-15/IL-15R IgM immune stimulating antibody for the treatment of patients with solid tumors and hematologic malignancies. The antibody binding domains of IGM-7354 target PD-L1 and are designed to concentrate the delivery of IL-15 in the area of cells with PD-L1 expression, including PD-L1-expressing tumors and tumor-draining lymph nodes. Through this targeting, IGM-7354 may be able to enhance the immune system’s activity in the tumor microenvironment, while potentially reducing systemic toxicities.

About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.

SOURCE: IGM Biosciences

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