Perspective Therapeutics, Inc.（CATX）のニュースとイベントCATXPerspective Therapeutics, Inc.

Perspective Therapeutics Receives Orphan Drug Designation for [Pb]VMT-alpha-NET

Perspective Therapeutics announced that the European Commission has granted orphan medicinal product designation for [Pb]VMT-alpha-NET for the treatment of gastroenteropancreatic neuroendocrine tumors. The designation follows a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency. Orphan medicinal product designation by the EC may provide certain development and commercial incentives, including protocol assistance, fee reductions, and, if approved, up to 10 years of market exclusivity. Criteria for designation include the potential to provide significant benefit to patients affected by the condition.

Perspective Therapeutics Doses First Meningioma Patient with [212Pb]VMT-alpha-NET

Perspective Therapeutics announced that the first meningioma patient was dosed with [212Pb]VMT-alpha-NET in the Company's ongoing Phase 1/2a study. The new cohort is intended to evaluate the safety, dosimetry, and preliminary anti-tumor activity of lead-based alpha-particle therapy with [212Pb]VMT-alpha-NET for meningioma. The initiation of the meningioma cohort reflects The Company's broader strategy to evaluate [212Pb]VMT-alpha-NET across somatostatin receptor subtype 2 - expressing tumor types beyond neuroendocrine tumors, or NETs. Meningiomas are the most common primary brain tumors in adults, accounting for ~40% of all central nervous system tumors diagnosed annually in the U.S. Approximately 20% of all diagnosed meningioma cases are grades 2 and 3 by World Health Organization 2021 grading, while approximately 30% of patients with diagnosed grade 1 disease either have inoperable disease or experience recurrence of their disease. Although surgery and radiation remain standard treatments, patients with recurrent, progressive, or unresectable disease often face limited therapeutic options and poor long-term outcomes.2 Meningiomas consistently express SSTR24, making them an attractive target for targeted radiopharmaceutical therapy. Perspective designed [212Pb]VMT-alpha-NET to target and deliver 212Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study of [212Pb]VMT-alpha-NET in patients with unresectable or metastatic SSTR2-positive tumors who have not received prior radiopharmaceutical therapies.

Perspective Therapeutics Initiates New Drug Clinical Trials

Perspective Therapeutics announced that the first patients were dosed with [212Pb]VMT-alpha-NET and [212Pb]PSV359 in two new cohorts of Phase 1/2a studies in neuroendocrine tumors and solid tumors, respectively. The first patient was treated with [212Pb]VMT-alpha-NET in a fourth cohort of the company's ongoing Phase 1/2a clinical trial of [212Pb]VMT-alpha-NET in patients with unresectable or metastatic somatostatin receptor type 2 expressing neuroendocrine tumors, or NETs. The design of this dosing regimen will help determine whether front-loading could change response kinetics and further improve response rate and tolerability at the same cumulative administered dose. Additionally, the first patient was treated with [212Pb]PSV359 in a third cohort of the company's Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha. The company is conducting a multi-center, open-label, dose-escalation, dose-expansion study of [212Pb]VMT-alpha-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies.