Perspective Therapeutics Initiates Phase 1/2a Clinical Trials for Two Targeted Alpha Therapy Oncology Product Candidates
- VMT-α-NET for neuroendocrine cancers and VMT01 for melanoma are both entering therapeutic trials under IND at leading US institutions.
- First melanoma patient screened and imaged with [203Pb]VMT01 to determine eligibility for [212Pb]VMT01 treatment.
- Preliminary results from initial cohorts expected by end of 2023.
RICHLAND, WASHINGTON & CORALVILLE, IOWA , June 21, 2023 (GLOBE NEWSWIRE) -- 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, today announced that it has initiated clinical trial sites and commenced the enrollment period for its 212Pb-labeled therapeutic product candidates, VMT-α-NET and VMT01.
“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.
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 (VMT01) 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 key isotopes for clinical trial and commercial operations.
For more information, please visit the Company’s website at www.perspectivetherapeutics.com .
Safe Harbor Statement
Statements in this news release about Perspective Therapeutics’ future expectations, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include statements about our clinical development plans and the expected timing thereof. This statement is included for the express purpose of availing Perspective Therapeutics, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as whether additional studies or trials are released that support the conclusions of the studies or trials discussed in this news release, whether ongoing patient results are favorable and in line with the conclusions of clinical trials and initial patient results, physician acceptance, training and use of our products and product candidates, whether the anticipated benefits of the Company’s therapies are realized; market acceptance and recognition of the Company’s products; the Company’s ability to enforce its intellectual property rights; successful completion of future research and development activities; whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use our products in their various forms; the procedures and regulatory requirements mandated by the FDA for animal trials, human trials, preclinical studies, Phase I and II approvals and 510(k) approval and reimbursement codes; changes in applicable laws and regulations applicable to our products and product candidates, and other risks detailed from time to time in Perspective Therapeutics, Inc., reports filed with the U.S. Securities Exchange Commission.
Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
