[SITC 2024] IND submission planned for end of next year

November 14, 2024 — MUSTBIO announced the presentation of preclinical research on its αPD-1/IL-2v bispecific fusion protein, MB5029, at the Society for Immunotherapy of Cancer (SITC 2024) Annual Meeting, held in Houston, Texas, from November 6 to 10.

MB5029 is a αPD-1/IL-2v with no IL-2Rα (non-α) and attenuated IL-2Rγ binding. This mechanism prevents immune cell activation in peripheral blood with low PD-1 expression but selectively activates immune cells within the tumor microenvironment (TME), where PD-1 is overexpressed, improving tolerability compared to conventional IL-2 variants (IL-2v).

MUSTBIO has completed cell line development and is conducting GLP toxicity studies, aiming to submit an Investigational New Drug (IND) application by the end of next year.

Key findings showed that MB5029 effectively inhibited tumor growth and increased in tumor-infiltrating lymphocytes (TILs) in ICI-resistant mouse tumor models, where PD-1 or PD-L1 immune checkpoint inhibitors are ineffective. Additionally, MB5029 showed dose-dependent pharmacokinetic (PK) and pharmacodynamic (PD) profiles in mice and monkeys, with safety observed even at high doses.

MUSTBIO CEO Maengsup Kim commented, “Conventional IL-2v show strong immune cell activation and proliferation but its clinical application has been limited due to systemic toxicity. With MB5029’s improved tolerability and potent antitumor efficacy, we expect the drug to overcome the limitations of existing immune checkpoint inhibitors and become a next-generation immune-oncology drug.”

MUSTBIO is advancing research and development on the ‘BICSTA’ multi-specific antibody platform technology, which enhances productivity, and the ‘STARKINE’ cytokine-based technology, which facilitates generation of novel cytokine variants through modulation of cytokine binding affinity. The company is developing next-generation multi-specific antibodies leveraging these platforms.

MUSTBIO is also developing a tri-specific fusion protein based on αPD-1/αVEGF.

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