Perspective Therapeutics, Inc. announced the selection of investigational product [212Pb]VMT-a-NET for the treatment of certain patients with neuroendocrine tumors (?NETs?) by the U.S. Food and Drug Administration (?FDA?) to participate in the Chemistry, Manufacturing, and Controls (?CMC?) Development and Readiness Pilot (?CDRP?) program. FDA's CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (IND) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access. The [212Pb]VMT-a-NET IND is for the treatment of Peptide Receptor Radionuclide Therapy (?PRRT?)-naïve patients with somatostatin receptor subtype 2 (?SSTR2?)-positive unresectable or metastatic NETs (including gastroenteropancreatic [?GEP]-NETs?

or bronchial NETs and pheochromocytomas and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. This program was granted Fast Track Designation (FTD) based on preclinical data by the FDA. Applicants for inclusion in the CDRD Program are required to submit planned CMC tasks and activities intended to yield complete CMC data and information to be included in a marketing application, such as plans for ensuring product availability for commercial launch.

About the Phase 1/2a Study of [212Pb]VMT-a-NET: This is a multi-center open-label study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-a-NET, PRRT-naïve patients with SSTR2-positive unresectable or metastatic NETs (including GEP-NETs, bronchial NETs and pheochromocytomas, and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. The first part of the study involves dose-escalation designed to determine the maximum tolerated dose (?MTD?) or maximum feasible dose (?MFD?) based on observed dose-limiting toxicities (DLTs) and adverse events (AEs) following a single administration of [212Pb]VMT-a-NET. The first patient cohort received 111 MBq (3mCi) per dose.

The second cohort will receive administered activities of 185 MBq (5mCi), with cohorts 3 and 4 receiving 370 MBq (10 mCi) and 555 MBq (15 mCi), respectively. According to the modified toxicity probability interval 2 (mTPI-2) study design, intermediate de-escalation doses are also possible to allow selection of the optimal activity dose to take forward into the dose expansion part of the study. The second part of the study is a dose-expansion phase based on the identified MTD/MFD.