FDA Grants Fast Track Designation to VMT01 for Unresectable/Metastatic MC1R+ Melanoma
Source: OncLive, September 2024
The FDA has granted fast track designation to the development of the targeted alpha-particle therapy (212Pb) VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma, as well as those who have demonstrated melanocortin 1 receptor (MC1R) expression, Perspective Therapeutics announced in a news release.
VMT01 is designed to target and deliver the alpha-emitting isotope 212Pb to tumor sites expressing MC1R, a protein that is often overexpressed in metastatic melanoma. This proprietary clinical-stage low molecular weight peptide can also be labeled with 203Pb to enable patient selection, diagnostic imaging, and dosimetry via SPECT imaging.
VMT01 was previously evaluated in a completed pilot imaging study at the Mayo Clinic, in Rochester, Minnesota, and is currently being evaluated in a phase 1/2a study (NCT05655312).