Perspective Therapeutics to Advance Investigation of Potential First-In-Class Radiopharmaceutical Therapy [212Pb]VMT01 Based on Data Presented at the 21st International Congress of the Society for Melanoma Research
Perspective Therapeutics (NYSE AMERICAN: CATX) presented initial results from its Phase 1/2a study of [212Pb]VMT01, a MC1R-targeted radiopharmaceutical therapy for melanoma, at the 21st International Congress of the Society for Melanoma Research. Key findings include:
1. Safety: No dose-limiting toxicities observed at 3.0 and 5.0 mCi doses.
2. Efficacy: Prolonged progression-free survival and tumor response in heavily pretreated patients at the 3.0 mCi dose.
3. The trial is progressing with a lower 1.5 mCi dose to optimize immunostimulatory activities, both as monotherapy and in combination with nivolumab.
4. The Safety Monitoring Committee recommended exploring the 1.5 mCi dose level as a single agent and in combination with nivolumab.
Perspective Therapeutics (NYSE AMERICAN: CATX) ha presentato i risultati iniziali del suo studio di Fase 1/2a su [212Pb]VMT01, una terapia radiopharmaceutica mirata a MC1R per il melanoma, durante il 21° Congresso Internazionale della Society for Melanoma Research. I risultati chiave includono:
1. Sicurezza: Nessuna tossicità dose-limitante osservata a dosi di 3.0 e 5.0 mCi.
2. Efficacia: Prolungamento della sopravvivenza libera da progressione e risposta tumorale in pazienti gravemente pretrattati alla dose di 3.0 mCi.
3. Lo studio sta procedendo con una dose inferiore di 1.5 mCi per ottimizzare le attività immunostimolatorie, sia come monoterapia che in combinazione con nivolumab.
4. Il Comitato di Monitoraggio della Sicurezza ha raccomandato di esplorare il livello di dose di 1.5 mCi sia come agente singolo che in combinazione con nivolumab.
Perspective Therapeutics (NYSE AMERICAN: CATX) presentó los resultados iniciales de su estudio de Fase 1/2a sobre [212Pb]VMT01, una terapia radifarmacéutica dirigida a MC1R para el melanoma, en el 21° Congreso Internacional de la Sociedad para la Investigación del Melanoma. Los hallazgos clave incluyen:
1. Seguridad: No se observaron toxicidades limitantes por dosis en las dosis de 3.0 y 5.0 mCi.
2. Eficacia: Supervivencia libre de progresión prolongada y respuesta tumoral en pacientes gravemente tratados previamente a la dosis de 3.0 mCi.
3. El ensayo está avanzando con una dosis más baja de 1.5 mCi para optimizar las actividades inmunoestimuladoras, tanto como monoterapia como en combinación con nivolumab.
4. El Comité de Monitoreo de Seguridad recomendó explorar el nivel de dosis de 1.5 mCi como agente único y en combinación con nivolumab.
Perspective Therapeutics (NYSE AMERICAN: CATX)는 21회 국제 멜라노마 연구 학회에서 멜라노마에 대한 MC1R 표적 방사선 약리 치료제인 [212Pb]VMT01의 1/2a상 연구 초기 결과를 발표했습니다. 주요 발견 사항은 다음과 같습니다:
1. 안전성: 3.0 및 5.0 mCi 용량에서 용량 제한 독성이 관찰되지 않았습니다.
2. 효능: 3.0 mCi 용량에서 중증으로 전처리된 환자에서 진행 없는 생존 기간과 종양 반응이 연장되었습니다.
3. 임상 시험은 면역 자극 활동을 최적화하기 위해 1.5 mCi의 낮은 용량으로 진행되고 있으며, 단독 요법 및 nivolumab와의 병용으로 진행되고 있습니다.
4. 안전성 모니터링 위원회는 1.5 mCi 용량을 단독 약제로서 및 nivolumab과의 병용으로 탐색할 것을 권장했습니다.
Perspective Therapeutics (NYSE AMERICAN: CATX) a présenté les résultats préliminaires de son étude de Phase 1/2a sur [212Pb]VMT01, une thérapie radiopharmaceutique ciblant MC1R pour le mélanome, lors du 21e Congrès International de la Société de Recherche sur le Mélanome. Les résultats clés comprennent :
1. Sécurité: Aucune toxicité limitante par dose observée à des doses de 3.0 et 5.0 mCi.
2. Efficacité: Prolongement de la survie sans progression et réponse tumorale chez des patients lourdement prétraités à la dose de 3.0 mCi.
3. L'essai progresse avec une dose inférieure de 1.5 mCi pour optimiser les activités immunostimulatrices, à la fois en monothérapie et en association avec le nivolumab.
4. Le Comité de Surveillance de la Sécurité a recommandé d'explorer le niveau de dose de 1.5 mCi en tant qu'agent unique et en association avec le nivolumab.
Perspective Therapeutics (NYSE AMERICAN: CATX) präsentierte die ersten Ergebnisse seiner Phase 1/2a-Studie zu [212Pb]VMT01, einer auf MC1R ausgerichteten radioaktiven Therapie gegen Melanome, auf dem 21. Internationalen Kongress der Gesellschaft für Melanomforschung. Zu den wichtigsten Erkenntnissen gehören:
1. Sicherheit: Keine dosislimitierenden Toxizitäten bei 3.0 und 5.0 mCi Dosen beobachtet.
2. Wirksamkeit: Verlängerte progressionsfreie Überlebenszeit und Tumoransprechen bei stark vorbehandelten Patienten mit der Dosis von 3.0 mCi.
3. Die Studie wird mit einer niedrigeren Dosis von 1.5 mCi fortgesetzt, um immunstimulierende Aktivitäten sowohl als Monotherapie als auch in Kombination mit Nivolumab zu optimieren.
4. Das Sicherheitsüberwachungskomitee empfahl, die Dosisstufe von 1.5 mCi sowohl als Einzelmittel als auch in Kombination mit Nivolumab zu untersuchen.
- No dose-limiting toxicities observed in the Phase 1/2a study of [212Pb]VMT01
- Prolonged progression-free survival and tumor response observed in heavily pretreated patients at low dose
- FDA granted Fast Track Designation for [212Pb]VMT01 clinical development
- Combination cohort with nivolumab at 1.5 mCi per dose is now open for enrollment
- Consistent results between preclinical and initial clinical findings
- In Cohort 2, patients progressed after either the first cycle (3 patients) or the second cycle (4 patients)
Insights
The initial results from Perspective Therapeutics' Phase 1/2a study of [212Pb]VMT01 for melanoma treatment are promising. Key findings include:
- Safety: No dose-limiting toxicities observed at 3.0 and 5.0 mCi doses, with mostly Grade 1 and 2 adverse events.
- Efficacy: Prolonged progression-free survival and tumor response in heavily pretreated patients at the lower 3.0 mCi dose.
- Mechanism: Consistent with preclinical data showing immunostimulatory effects at lower radiation doses.
The study is now exploring an even lower 1.5 mCi dose, both as monotherapy and in combination with nivolumab. This approach aligns with the dual mechanism of action: direct cell killing at high doses and immune-mediated cell death at low doses. The Fast Track Designation from the FDA underscores the potential of this novel radiopharmaceutical therapy.
The results suggest [212Pb]VMT01 could enhance immunotherapy response in melanoma patients who don't benefit from current treatments. This aligns with the growing trend of combining targeted therapies with immunotherapies to improve outcomes in difficult-to-treat cancers.
This clinical update from Perspective Therapeutics (NYSE AMERICAN: CATX) is significant for investors. Key financial implications include:
- Pipeline Advancement: Positive early-stage results for [212Pb]VMT01 in melanoma treatment could accelerate the development timeline and increase the probability of eventual commercialization.
- Market Potential: Targeting patients who don't respond to current immunotherapies addresses a significant unmet need in the lucrative melanoma market.
- Platform Validation: Success with [212Pb]VMT01 validates Perspective's alpha-emitter platform, potentially increasing the value of their entire pipeline.
- Partnerships: Positive data may attract potential partners or collaborators, possibly leading to licensing deals or funding opportunities.
With a market cap of
- [212Pb]VMT01 was observed to be safe, and no dose-limiting toxicities were observed at the two doses tested (3.0 and 5.0 mCi)
- Prolonged progression-free survival and tumor response were observed in heavily pretreated patients who received the low (3.0 mCi) dose of [212Pb]VMT01, consistent with preclinical findings
- Trial is progressing with testing [212Pb]VMT01 at a lower (1.5mCi) dose to further elucidate the optimal dose for immunostimulatory activities on the tumor microenvironment in melanoma both as monotherapy and in combination with nivolumab
SEATTLE, Oct. 11, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced that initial results from its Phase 1/2a study of [212Pb]VMT01 are being presented at the 21st International Congress of the Society for Melanoma Research (“SMR”), being held on October 10-13, 2024 in New Orleans, Louisiana.
VMT01 is a MC1R-targeted radiopharmaceutical therapy (RPT) that can be radiolabeled with either 203Pb for patient selection and dosimetry assessments, or 212Pb for alpha particle therapy. In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors (ICIs).1 On the basis of these results, the U.S. Food and Drug Administration granted Fast Track Designation for the clinical development of [212Pb]VMT01.
This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.
Three patients were enrolled in Cohort 1, while seven patients were enrolled in Cohort 2. Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy.
- Safety findings: No dose limiting toxicities were observed among any patients, and no adverse events led to treatment discontinuation. Treatment emergent adverse events (“TEAEs”) were mostly Grades 1 and 2. None of the four cases of grade 3 TEAEs were deemed to be treatment related. There were no grade 4 or 5 TEAEs.
No renal toxicities have been reported to date (there were no clinically significant changes in serum BUN or creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.
- Efficacy findings: All patients in Cohort 1 completed three treatments, with one patient experiencing a RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively. In Cohort 2, patients progressed after either the first cycle (3 patients) or the second cycle (4 patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses.
The Safety Monitoring Committee ("SMC") has reviewed these findings. The SMC recommended exploring a lower dose level of 1.5 mCi per dose, which is lower than the dose administered in Cohort 1, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy is planned. The combination cohort at 1.5 mCi per dose with nivolumab is active and now open for enrollment.
“Immunotherapies have transformed the care of patients with cancer, and these treatments are particularly beneficial for some patients with metastatic melanoma,” said Dr. Zachary Morris, lead investigator of the VMT01 Phase 1/2a study and Associate Professor and Chair of the Department of Human Oncology at the University of Wisconsin School of Medicine and Public Health. “However, many patients do not respond to immunotherapies. Results from the VMT01 study suggest that we are on the right track in understanding how response to immunotherapy may be enhanced by a radiopharmaceutical, and I am hopeful that a combined treatment approach involving such an agent together with immune checkpoint inhibitors could extend the benefits of immunotherapy to a greater number of patients with metastatic melanoma. I look forward to continued participation in the VMT01 study.”
Markus Puhlmann, Chief Medical Officer of Perspective, commented, “It is an important first milestone in the development program for VMT01 to see that the single agent anti-tumor effect observed in this initial clinical trial was consistent with our published preclinical findings. As determined by the Safety Monitoring Committee, safety observations from the study support moving ahead with the combination cohort with nivolumab, a setting where the encouraging additive effects of combining VMT01 with immunotherapy treatments were seen in preclinical studies.”
Thijs Spoor, Chief Executive Officer of Perspective, added, “This initial scientific presentation of clinical data from our VMT01 therapeutic study is very encouraging in this heavily pretreated patient population, who have no other options. We are delighted to have observed efficacy at such a low dose of radiation, as this exciting result has been seen in our extensive preclinical work with this indication. This data also highlights the versatility of our proprietary alpha-emitter platform, enabling the development of potential new cancer therapies and the exploration of combinations with established treatments. We remain on track to provide an update this calendar year on the company sponsored Phase 1/2a study of VMT-α-NET for unresectable or metastatic somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors. In the next twelve months, we expect data to continue to accrue for both clinical programs, as well as initiate therapeutic dosing of at least one new pre-IND asset.”
About VMT01
Perspective designed VMT01 to target and deliver 212Pb to tumor sites expressing MC1R, a protein that can be overexpressed in metastatic melanoma tumors. The Company is conducting a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. In September 2024, the Company announced that the U.S. Food and Drug Administration granted Fast Track Designation for the development of [212Pb]VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma and who have demonstrated MC1R tumor expression. The FDA’s Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs.2
About Melanoma
Melanoma is a cancer of the skin arising from uncontrollable growth of melanocytes, the melanin producing cells of the body. Metastatic melanoma is the result of melanoma that has progressed through the layers of skin, infiltrated the blood stream or lymphatic system, and traveled to other areas of the body to metastasize. In the United States, there are approximately 100,000 new diagnoses of melanoma annually and approximately 8,300 deaths annually from metastatic melanoma.3 Metastatic melanoma has a poor prognosis with limited survival of
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 express or implied statements concerning, among other things, the Company’s ability to pioneer advanced treatment applications for cancers throughout the body; expectations regarding the advancement of the Company’s clinical development programs, including its plans and anticipated timing with respect to [212Pb]VMT01’s clinical development, the release of an update on the Company-sponsored Phase 1/2a study of VMT-α-NET for unresectable or metastatic SSTR2-positive neuroendocrine tumors, the accrual of additional data for the Company’s [212Pb]VMT01 and VMT-α-NET programs, and the initiation of therapeutic dosing of a new pre-IND asset; the potential for [212Pb]VMT01 to be administered as a single agent or in combination with other agents and for the Company to explore different dose levels in connection with its [212Pb]VMT01 trial; expectations regarding the potential benefits conferred by the Fast Track Designation of [212Pb]VMT01, which was based on non-clinical results submitted by the Company; the belief that the Company is on the “right track in understanding how response to immunotherapy may be enhanced by a radiopharmaceutical” and the potential for a combined treatment approach involving a radiopharmaceutical with immune checkpoint inhibitors to “extend the benefits of immunotherapy to a greater number of patients with metastatic melanoma;” the versatility of the Company’s alpha-emitter platform and its ability to enable the development of potential new cancer therapies and the exploration of combinations with established treatments; expectations regarding the therapeutic benefits of the Company’s programs; the ability of the Company’s proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting peptides; the opportunity to personalize treatment and optimize patient outcomes using the Company’s complementary imaging diagnostics that incorporate the same targeting peptides; the Company's expectation that its "theranostic" approach enables the ability to see specific tumors and then treat them 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; 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; the Company’s intentions to improve important aspects of care in cancer treatment; 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. Certain 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 and Quarterly Report on Form 10-Q 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.
1Li M, Liu D, Lee D, et al. Targeted Alpha-Particle Radiotherapy and Immune Checkpoint Inhibitors Induces Cooperative Inhibition on Tumor Growth of Malignant Melanoma. Cancers (Basel). 2021;13(15):3676. Published 2021 Jul 22. doi:10.3390/cancers13153676
2Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/media/86377/download?attachment. Accessed August 25, 2024.
3Cancer Stat Facts: Melanoma of the Skin. https://seer.cancer.gov/statfacts/html/melan.html. Accessed August 25, 2024.
4Su DG, Djureinovic D, Schoenfeld D, et al. Melanocortin-1 Receptor Expression as a Marker of Progression in Melanoma. JCO Precis Oncol. 2024;8:e2300702. doi:10.1200/PO.23.00702.
5Ascierto PA, Lipson EJ, Dummer R, et al. Nivolumab and Relatlimab in Patients With Advanced Melanoma That Had Progressed on Anti-Programmed Death-1/Programmed Death Ligand 1 Therapy: Results From the Phase I/IIa RELATIVITY-020 Trial. J Clin Oncol. 2023;41(15):2724-2735. doi:10.1200/JCO.22.02072
6Arance A, de la Cruz-Merino L, Petrella TM, et al. Phase II LEAP-004 Study of Lenvatinib Plus Pembrolizumab for Melanoma With Confirmed Progression on a Programmed Cell Death Protein-1 or Programmed Death Ligand 1 Inhibitor Given as Monotherapy or in Combination [published correction appears in J Clin Oncol. 2023 May 1;41(13):2454. doi: 10.1200/JCO.23.00439]. J Clin Oncol. 2023;41(1):75-85. doi:10.1200/JCO.22.00221
7Chesney J, Lewis KD, Kluger H, et al. Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. J Immunother Cancer. 2022;10(12):e005755. doi:10.1136/jitc-2022-005755
FAQ
What is the purpose of Perspective Therapeutics' [212Pb]VMT01 therapy for melanoma?
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How is Perspective Therapeutics (CATX) planning to advance the [212Pb]VMT01 therapy based on the recent study results?
What is the significance of the FDA's Fast Track Designation for [212Pb]VMT01 in Perspective Therapeutics' (CATX) development process?
