January 2023
Modulation Therapeutics Announces successful metastatic Uveal Melanoma patient enrollment for a Phase 1 Clinical Trial of the First in Class Targeted Alpha Therapeutic (TAT), 225Ac-MTI-201.
The Phase I trial was initiated in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL on July 21, 2022, under the clinical leadership of Dr. Nikhil I. Khushalani, Vice Chair of the Department of Cutaneous Oncology at Moffitt. In this actively accruing dose escalation trial in advanced uveal melanoma, the primary objective is to determine the safety and tolerability of a single dose of intravenously administered 225Ac-MTI-201. The secondary end-points are to determine the pharmacokinetics of 225Ac-MTI-201 and assess efficacy in this deadly disease.
225Ac-MTI-201 is analogous to the FDA-approved Peptide Receptor Radiotherapeutic (PRRT) Lutathera which targets somatostatin subtype 2 receptors for delivery of the beta particle emitting radionuclide, 177Lu, for the treatment of gastroenteropancreatic neuroendocrine tumors. 225Ac-MTI-201 targets the melanocortin 1 receptor which is highly expressed on metastatic uveal melanoma tumors and delivers the alpha-particle emitting radionuclide, 225Ac.
Currently, there is only one FDA approved treatment for metastatic uveal melanoma and only half of uveal melanoma patients are eligible for this treatment. Modulation Therapeutics and collaborators seek to aid all patients experiencing this devastating disease with this First in Class Targeted Alpha Therapy. The FDA has granted Orphan Drug Designation to 225Ac-MTI-201. Modulation Therapeutics is looking forward to successful completion of the phase 1 trial in order to support an early to market phase 2 strategy for this indication.
More information on the phase 1 clinical trial with 225Ac-MTI-201 can be found at: "www.clinicaltrials.gov" (Trial Identifier: NCT05496686).