Perspective Therapeutics’ VMT-α-NET Protocols Presented at the North American Neuroendocrine Tumor Society (NANETS) 2023 Symposium

Rhea-AI Summary

Perspective Therapeutics announces two upcoming investigator-initiated trials at NANETS 2023 Symposium

Positive

• Perspective Therapeutics plans to conduct Phase 1 and Phase 1/2 trials of Pb-212-VMT-alpha-NET in different types of tumors
• Enrollment for both studies is expected to begin in Q1 2024
• The trials aim to investigate the safety and efficacy of Pb-212-VMT-alpha-NET in patients with metastatic or inoperable tumors

Negative

• None.

SEATTLE, Oct. 10, 2023 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced that two upcoming investigator-initiated trials (IIT) were presented at the North American Neuroendocrine Tumor Society (NANETS) 2023 Symposium in Montreal, Canada, which was held October 4-6, 2023.

Presentation One: Phase 1 Trial of Pb-212-VMT-alpha-NET in Select Metastatic or Inoperable Somatostatin Receptor Positive Tumors

Summary: This presentation detailed the planned protocol for the IIT Phase 1 trial of Pb-212-VMT-alpha-NET in patients with metastatic or inoperable somatostatin receptors positive (SSTR+) tumors to investigate if this new treatment can improve management of patients naïve to prior radioligand therapy. The study is an open-label, single arm, single-center, phase 1 trial evaluating the safety, tolerability, and pharmacokinetic properties of the alpha-emitting, systemic radioligand therapy agent Pb-212-VMT-alpha-NET in five different SSTR+ tumors: gastrointestinal neuroendocrine tumors (GI-NET), pheochromocytoma and paraganglioma (PPGL), small cell lung cancer (SCLC), renal cell carcinoma (RCC), and head and neck (H&N). Enrollment for this study is expected to commence in the first quarter of 2024.

Presenter: E. Mena, MD, National Cancer Institute, National Institutes of Health

Presentation Two: Phase 1/2 Trial of Pb-212-VMT-alpha-NET in GI Neuroendocrine Tumors and Pheochromocytoma/Paraganglioma Previously Treated with Radioligand Therapy

Summary: This presentation detailed the planned protocol for the IIT Phase 1/2 trial designed to determine if such a new treatment can improve management of patients who have progressed on beta-emitting radioligand therapy. This study is an open-label, single arm, single-center, Phase 1/2 study evaluating the safety, tolerability, and pharmacokinetic properties of the alpha-emitting, systemic radioligand therapy agent Pb-212-VMT-alpha-NET in somatostatin receptors (SSTR+) metastatic GI neuroendocrine tumors (GI-NETs) and pheochromocytoma/paraganglioma (PPGL) tumors. Enrollment for this study is expected to commence in the first quarter of 2024.

Presenter: J. Del Rivero, MD, National Cancer Institute, National Institutes of Health

“There are currently no approved targeted radiopharmaceuticals for NETs patients outside of the gastroenteropancreatic indication,” said Chief Executive Officer Thijs Spoor of Perspective Therapeutics. “We are excited to expand clinical studies to a wider range of cancer types in order to potentially expand therapeutic options for patients with these difficult to treat tumors.”

“We are delighted to have the NIH conduct these studies to investigate the safety and efficacy of [²¹²Pb]VMT-alpha-NET in these expanded patient populations.” said Chief Medical Officer Markus Puhlmann, MD MBA, of Perspective Therapeutics. “These clinical studies are evaluating [²¹²Pb]VMT-alpha-NET in a wide range of neuroendocrine tumors, where the unmet need is greatest.”

The presentation abstracts can be accessed on the conference website at https://nanets.net/. The presentations will also be made available on the Company’s website at www.perspectivetherapeutics.com.

About neuroendocrine tumors
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis.

About VMT-α-NET
VMT-α-NET is a clinical stage targeted alpha particle therapy (TAT) radiopharmaceutical being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. VMT-α-NET incorporates Perspective Therapeutics’ proprietary lead-specific chelator (PSC) to bind Pb-203 for SPECT imaging, and Pb-212 for alpha particle therapy.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a diversified medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope Lead-212 to deliver powerful 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 have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions in the United States. The Company has also developed a proprietary Lead-212 generator to enable isotope supply for clinical trial and commercial operations.

In addition to its targeted alpha therapy programs, Perspective is the sole producer of Cesium-131 brachytherapy seeds which are commercially available in the United States for the treatment of prostate cancer and other solid tumors.

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

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements concerning, among other things, the Company’s clinical development plans and the expected timing thereof as a result of Fast Track designation or otherwise; the expected timing for availability and release of data as a result of Fast Track designation or otherwise; expectations regarding the potential market opportunities for the Company’s product candidates; the potential functionality, capabilities, and benefits of the Company’s product candidates and the potential application of these product candidates for other disease indications; the Company’s expectations, beliefs, intentions, and strategies regarding the future; and other statements that are not historical fact.

The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the Company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the potential that regulatory authorities may not grant or may delay approval for the Company’s product candidates; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; early clinical trials may not be indicative of the results in later clinical trials; clinical trial results may not support regulatory approval or further development in a specified indication or at all; actions or advice of regulatory authorities may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for the Company’s product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s expectations, projections and estimates regarding expenses, future revenue, capital requirements, and the availability of and the need for additional financing; the Company’s ability to obtain additional funding to support its clinical development programs; the availability or potential availability of alternative products or treatments for conditions targeted by the Company that could affect the availability or commercial potential of its product candidates; the ability of the Company to manage growth and successfully integrate its businesses; the Company’s ability to maintain its key employees; sufficient training and use of the Company’s products and product candidates; the market acceptance and recognition of the Company’s products and product candidates; the Company’s ability to maintain and enforce its intellectual property rights; the Company’s ability to maintain its therapeutic isotope supply agreement with the Department of Energy; the Company’s ability to continue to comply with the procedures and regulatory requirements mandated by the FDA for additional trials, Phase 1 and 2 approvals, Fast Track approvals, and 510(k) approval and reimbursement codes; and any changes in applicable laws and regulations. Other factors that may cause the Company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s most recent Transition Report on Form 10-KT and the Company’s most recent Quarterly Report on Form 10-Q, each filed with the Securities and Exchange Commission (the “SEC”), in the Company’s other filings with the SEC, and in the Company’s future reports to be filed with the SEC and available at www.sec.gov.

Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

 

FAQ

What are the upcoming trials announced by Perspective Therapeutics?

Perspective Therapeutics has announced two upcoming investigator-initiated trials of Pb-212-VMT-alpha-NET in different types of tumors.

When will the enrollment for these trials begin?

Enrollment for both trials is expected to commence in the first quarter of 2024.

What is the objective of these trials?

The trials aim to investigate the safety and efficacy of Pb-212-VMT-alpha-NET in patients with metastatic or inoperable tumors.

Where can I access the presentation abstracts and recordings?

The presentation abstracts can be accessed on the conference website at https://nanets.net/. The presentations will also be made available on Perspective Therapeutics' website at www.perspectivetherapeutics.com.