Perspective Therapeutics Selected by FDA to Participate in the CDRP Program to Expedite Chemistry, Manufacturing, and Controls Development Readiness for VMT-α-NET in NETs
Perspective Therapeutics, Inc. (CATX) has been selected by the FDA to participate in the CDRP program for the development of [212Pb]VMT‐α‐NET for the treatment of patients with NETs. The program aims to expedite the CMC development of novel products under IND applications to provide earlier patient access. The investigational product is intended for PRRT-naïve patients with SSTR2-positive unresectable or metastatic NETs and has been granted Fast Track Designation by the FDA based on preclinical data.
Perspective Therapeutics (CATX) selected for FDA's CDRP program to expedite CMC development of [212Pb]VMT‐α‐NET for NETs treatment.
The investigational product [212Pb]VMT‐α‐NET aims to provide benefits beyond current standard of care in NETs.
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SEATTLE, April 30, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announces the selection of investigational product [212Pb]VMT‐α‐NET for the treatment of certain patients with neuroendocrine tumors (“NETs”) by the U.S. Food and Drug Administration (“FDA”) to participate in the Chemistry, Manufacturing, and Controls (“CMC”) Development and Readiness Pilot (“CDRP”) program.
FDA's CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (IND) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access.
The [212Pb]VMT‐α‐NET IND is for the treatment of Peptide Receptor Radionuclide Therapy (“PRRT”)-naïve patients with somatostatin receptor subtype 2 (“SSTR2”)-positive unresectable or metastatic NETs (including gastroenteropancreatic [“GEP]-NETs” or bronchial NETs and pheochromocytomas and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. This program was granted Fast Track Designation (FTD) based on preclinical data by the FDA.
Applicants for inclusion in the CDRD Program are required to submit planned CMC tasks and activities intended to yield complete CMC data and information to be included in a marketing application, such as plans for ensuring product availability for commercial launch.
“Our priority is to expeditiously investigate whether [212Pb]VMT‐α‐NET can benefit patients beyond current standard of care in NETs, and if so, be ready to supply patients,” said Thijs Spoor, Perspective Therapeutics' CEO. “We are grateful to be able to partner with the FDA to that end, and look forward to increased interactions with the FDA on manufacturing readiness.”
“We look forward to collaborating with the FDA while we are establishing a network of our own and partnered facilities strategically placed locally to major metropolitan areas that are within reach for delivery of Perspective’s radiopharmaceuticals for trials and ultimately for commercialization,” said Shane Cobb, Executive Vice President of Operations.
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 over 170,000 people living with this diagnosis.
About [212Pb]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 203Pb for SPECT imaging, and 212Pb for alpha particle therapy.
About the Phase 1/2a Study of [212Pb]VMT-α-NET
This is a multi-center open-label study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET, PRRT-naïve patients with SSTR2-positive unresectable or metastatic NETs (including GEP-NETs, bronchial NETs and pheochromocytomas, and paragangliomas) who have experienced tumor progression on, lack of symptom relief on, or intolerance to, approved therapies. . The first part of the study involves dose-escalation designed to determine the maximum tolerated dose (“MTD”) or maximum feasible dose (“MFD”) based on observed dose-limiting toxicities (DLTs) and adverse events (AEs) following a single administration of [212Pb]VMT-α-NET. The first patient cohort received 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. 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.
The second part of the study is a dose-expansion phase based on the identified MTD/MFD.
About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The Company has proprietary technology that utilizes the alpha emitting isotope 212Pb 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.
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. The Company has also developed a proprietary 212Pb 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
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 belief that it will continue to prioritize investigating whether [212Pb]VMT‐α‐NET can benefit patients beyond current standard of care in NETs, and if so, be ready to supply patients; the Company’s ability to partner with the FDA to that end; the Company’s belief that it will have increased interactions with the FDA on manufacturing readiness; the Company’s expectation that it will collaborate with the FDA while the Company establishes a network of its own and partnered facilities strategically placed locally to major metropolitan areas that are within reach for delivery of the Company’s radiopharmaceuticals for trials and ultimately for commercialization; the Company’s belief that it will establish a network of its own and partnered facilities strategically placed locally to major metropolitan areas that are within reach for delivery of the Company’s radiopharmaceuticals for trials and ultimately for commercialization; the Company's ability to develop successful proprietary technology that utilizes the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides; the Company's prediction that complementary imaging diagnostics that incorporate certain targeting peptides provide the opportunity to personalize treatment and optimize patient outcomes; the Company's expectation that its "theranostic" approach enables the ability to see specific tumors and then treat it to potentially improve efficacy and minimize toxicity; the Company’s ability to develop a proprietary 212Pb generator to secure key isotopes for clinical trial and commercial operations; the Company's clinical development plans and the expected timing thereof; the potential functionality, capabilities, and benefits of the Company's product candidates and the potential application of these product candidates for other disease indications; and 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 Company's ability to continue as a going concern, 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; whether there is 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, FDA 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 Annual Report on Form 10-K 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 news release are made as of this date. 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.
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