FDA grants orphan drug designation to AVS100 for advanced melanoma

Source: Healio, November 2022

The FDA granted orphan drug designation to AVS100 for the treatment of stage IIB through stage IV melanoma, according to the agent’s manufacturer.

ASV100 (Avstera Therapeutics) is a novel highly specific HDAC6 inhibitor with unique mechanisms in its ability to polarize macrophages to the anti-tumoral M1 phenotype, according to an Avstera Therapeutics-issued press release.

Macrophage differentiation and stabilization of M1 is important for maintaining anticancer responses. Studies conducted in preclinical animal models showed AVS100 reduced tumor growth and improved OS, according to the releasee.
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