Perspective Therapeutics Announces First Patient Dosed in Phase 1/2a Dose Escalation Trial of VMT01 of its Targeted Alpha-Particle Therapy (TAT), for Treatment of MC1R-positive Metastatic Melanoma

Rhea-AI Summary

Perspective Therapeutics announces the dosing of the first patient in their Phase 1/2a dose escalation trial for 212Pb-VMT01 in patients with MC1R+ metastatic melanoma. The trial aims to evaluate the safety and efficacy of the targeted alpha-particle therapy. Preliminary data from the study is expected in Q4 2023.

• First patient with MC1R-positive metastatic melanoma treated with ²¹²Pb-VMT01
  
• Preliminary data readout from dose escalation study expected Q4 2023
  
  

RICHLAND, Wash. & CORALVILLE, Iowa, Aug. 11, 2023 (GLOBE NEWSWIRE) --   Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announces the first patient was dosed at the University of Wisconsin in the Company’s Phase 1/2a dose escalation trial evaluating the safety and efficacy of ²¹²Pb-VMT01 in patients with MC1R+ metastatic melanoma. The trial is a first-in-human, non-randomized, multi-center open-label dose escalation, dose expansion study of ²¹²Pb-VMT01 in patients with histologically confirmed melanoma and a positive MC1R imaging scan.

“MC1R is implicated in the development of melanoma making it a promising target for potential treatment using radionuclide therapy,” said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics. “Today we achieved an important milestone as we work to access the potential of VMT01 as a targeted alpha-particle therapy for MC1R+ metastatic melanoma."

“We are excited to work with Perspective and announce that the first patient with metastatic melanoma has been dosed in the first-in-human study of ²¹²Pb-VMT01," said Zachary S. Morris, M.D., Ph.D., Vice Chair and Endowed Professor of Human Oncology, Program Director for the University of Wisconsin Bentson Research Fellowship, and Principal Investigator for the VMT01 clinical study. "With Perspective’s targeted radionuclide therapy, ²¹²Pb-VMT01, we have the advantage of treating all disease sites following intravenous injection.”

VMT01 has recently completed clinical imaging studies at Mayo Clinic, Rochester. Results were presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Chicago. In addition, published preclinical data demonstrated durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma.

“With the successful conclusion of our imaging study, we are excited to proceed with Perspective’s first-in-human dosing of ²¹²Pb-VMT01,” said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics. “As we advance through development milestones, our goal is to demonstrate ²¹²Pb-VMT01 can deliver systemic, precision, cytotoxic alpha particle radiation in order to selectively kill cancer cells. We look forward to presenting preliminary data from the study later in the year.”

The Phase 1/2a study consists of a dose-escalation part designed to determine the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) following a single administration of ²¹²Pb-VMT01 followed by a dose expansion based on the identified MTD/MFD for the selection of dose(s) for further clinical development. Patients may be eligible to receive up to 3 administrations of ²¹²Pb-VMT01 approximately 8 weeks apart. A dosimetry sub-study utilizing the SPECT imaging surrogate, ²⁰³Pb-VMT01, has been added to assess normal organ biodistribution, tumor uptake, radiation dosimetry, and correlation of uptake with observed toxicities and efficacy.

Clinical trial sites include Yale University, University of Iowa, Mayo Clinic in Rochester, Saint Louis University, Washington University, and University of Wisconsin.

²¹²Pb was supplied using Perspective’s proprietary VMT-α-GEN ²¹²Pb benchtop generator and final manufacturing was performed at Perspective’s GMP facility in Coralville, IA. Additional CDMO manufacturing sites are expected to be brought online in the coming months to enable broader coverage for sites across the US.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company is the sole producer of Cesium-131 brachytherapy seeds and has a proprietary technology that utilizes the isotope Lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company’s melanoma (VMT-01) and neuroendocrine tumor (VMT-α-NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations.

For more information, please visit the Company’s website at www.perspectivetherapeutics.com .

  
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FAQ

What is the purpose of Perspective Therapeutics' Phase 1/2a trial?

The purpose of the trial is to evaluate the safety and efficacy of 212Pb-VMT01, a targeted alpha-particle therapy, in patients with MC1R+ metastatic melanoma.

When is the expected completion of the dose escalation study?

Preliminary data from the dose escalation study is expected to be available in Q4 2023.

What is MC1R and why is it significant in melanoma treatment?

MC1R is implicated in the development of melanoma and is a promising target for potential treatment using radionuclide therapy.

Where was the first patient dosed in the study?

The first patient was dosed at the University of Wisconsin.

What are the clinical trial sites for the study?

The clinical trial sites include Yale University, University of Iowa, Mayo Clinic in Rochester, Saint Louis University, Washington University, and University of Wisconsin.