On June 20, 2023 Perspective Therapeutics, Inc. ("Perspective" or "the Company") (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy treatment options for multiple cancers, reported that it has initiated clinical trial sites and commenced the enrollment period for its 212Pb-labeled therapeutic product candidates, VMT-α-NET and VMT01 (Press release, Perspective Therapeutics, JUN 20, 2023, View Source [SID1234632852]).

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"We are excited to have our first clinical sites on board for our two lead development programs and to commence the enrollment period for these promising product candidates in patients with melanoma and neuroendocrine tumors," said Thijs Spoor, Perspective’s Chief Executive Officer.

The first product candidate, VMT-α-NET, is a result of Perspective’s intensive in-house research and development efforts to develop a best-in-class radiopeptide. The molecule incorporates the Company’s proprietary chelator technology platform that enables radiolabeling with isotopes of lead (Pb) and shows superior preclinical results as compared to other ligands in its class. On the basis of this promising preclinical data, VMT-α-NET was awarded Fast Track designation under the FDA’s expedited development program. Targeting the somatostatin type receptor 2 (SSTR2) which is over-expressed on a range of different cancer types including neuroendocrine tumors, VMT-α-NET was designed to deliver potent alpha-particle radiation directly to the tumor. Investigators at Fortis Memorial Research Institute (FMRI) located in Gurgaon, India are excited about initial patient experiences in their investigator initiated compassionate use of VMT-α-NET, results of which are expected to be presented at a major medical meeting in Q3 of 2023. An IND-enabled imaging and radiation dosimetry trial utilizing VMT-α-NET is also currently enrolling patients at the University of Iowa, IA, and similar imaging work is occurring at University Hospital Carl Gustav Carus in Dresden, Germany.

Perspective Therapeutics’ trial is a Phase 1/2a Dose Escalation of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (NCT05636618).
The second product candidate, VMT01, also delivers alpha-particle radiation to tumors by targeting the melanocortin 1 receptor (MC1R) present on melanoma cells. This product candidate has completed clinical imaging studies at Mayo Clinic, Rochester, and results will be presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Chicago being held from June 24 to 27, 2023. Recent published preclinical data from Perspective’s scientists show its potential to deliver durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma.

Perspective Therapeutics has initiated a Phase 1/2a Dose Escalation trial of [212Pb]VMT01 Targeted Alpha-Particle Therapy for patients with MC1R Positive unresectable and metastatic melanoma (NCT05655312).
Both US trials will be supplied with finished drug product from Perspective’s GMP manufacturing 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. Isotope will be supplied using Perspective’s proprietary VMT- α-GEN 212Pb benchtop generator.

"These clinical trials represent a significant advancement in our relentless pursuit of innovative and potent treatments for cancer," said Markus Puhlmann, Chief Medical Officer at Perspective. "We know that despite recent improvements in therapies for neuroendocrine cancers and melanoma, many patients become refractory to treatment. The targeted alpha-particle therapies that are being developed at Perspective have the potential to revolutionize the treatment of these and many other cancers. We look forward to seeing the results emerge over the coming months."

Preliminary results from the initial cohorts for both trials are expected to be available by the end of 2023.