Perspective Therapeutics Announces Clinical Collaboration Agreement with Bristol Myers Squibb to Evaluate [(212)Pb]VMT01 in Combination with Nivolumab in MC1R-Positive Metastatic Melanoma

SEATTLE , March 18, 2024 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate the safety and tolerability of Perspective’s targeted alpha-particle therapy [²¹²Pb]VMT01 in combination with Bristol Myers Squibb’s nivolumab in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans. This combination study is an amendment to the Company’s ongoing Phase1/2a study of [²¹²Pb]VMT01 in patients with metastatic melanoma. The study has completed enrollment in the first cohort and has commenced dosing in the second cohort.

Under the terms of the collaboration, Perspective will sponsor and fund the combination study and Bristol Myers Squibb will provide nivolumab for use in the study.

“We see great potential for synergistic treatment effect with our novel, systemically delivered, MC1R-targeted alpha-particle radioligand therapy, [²¹²Pb]VMT01, in combination with nivolumab, a well-studied immunotherapy,” commented Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. “Combination of [²¹²Pb]VMT01 with immune checkpoint inhibitors in a PD-1/CTLA-4-resistant preclinical melanoma model has demonstrated potential to generate a number of complete responses, significantly arresting tumor growth and extending survival^1,2. We look forward to expanding the clinical development of our radioligand therapy with standard of care immunotherapy to potentially bring novel solutions to patients suffering from this intractable disease.”

About the Phase 1/2a study of [²¹²Pb]VMT01
This ongoing trial (clinicaltrials.gov identifier NCT05655312) is a multi-center open-label dose escalation, dose expansion study of [²¹²Pb]VMT01 in subjects with histologically confirmed melanoma and positive MC1R imaging scans. The first part of the study is a dose escalation phase to determine the Maximum Tolerated radioactivity Dose (MTD) or Maximum Feasible radioactivity Dose (MFD) following a single administration of [²¹²Pb]VMT01. Patients with stage IV or unresectable stage III metastatic melanoma who have progressed on at least 1 approved first-line therapy will be scheduled to receive up to 3 administrations of [²¹²Pb]VMT01 approximately 8 weeks apart. The first patient cohort is scheduled to receive 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, if the MTD or MFD is not reached during escalation. 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.