Perspective Therapeutics Announces First Patient Dosed with [212Pb]VMT01 Monotherapy at 1.5 mCi in a Phase 1/2a Study of MC1R-Positive Metastatic Melanoma
Perspective Therapeutics (NYSE: CATX) has announced the dosing of the first patient in a new cohort of their Phase 1/2a trial evaluating [212Pb]VMT01, a targeted alpha-particle therapy for melanoma patients with positive MC1R imaging scans. The new cohort receives a 1.5 mCi monotherapy dose.
The trial expansion follows encouraging initial monotherapy results presented at the Society for Melanoma Research Congress in October 2024. Notably, this cohort includes patients with brain metastases, supported by previous imaging data showing tracer uptake in brain lesions. A parallel cohort combining [212Pb]VMT01 with nivolumab began in March 2025.
Perspective Therapeutics (NYSE: CATX) ha annunciato la somministrazione della prima dose al paziente in una nuova coorte del loro trial di fase 1/2a che valuta [212Pb]VMT01, una terapia con particelle alfa mirata per pazienti affetti da melanoma con scansioni di imaging MC1R positive. La nuova coorte riceve una dose di monoterapia di 1,5 mCi.
L'espansione dello studio segue risultati iniziali incoraggianti della monoterapia presentati al Congresso della Società per la Ricerca sul Melanoma nell'ottobre 2024. È importante notare che questa coorte include pazienti con metastasi cerebrali, supportata da dati di imaging precedenti che mostrano l'assorbimento del tracciante nelle lesioni cerebrali. Una coorte parallela che combina [212Pb]VMT01 con nivolumab è iniziata a marzo 2025.
Perspective Therapeutics (NYSE: CATX) ha anunciado la dosificación del primer paciente en una nueva cohorte de su ensayo de fase 1/2a que evalúa [212Pb]VMT01, una terapia de partículas alfa dirigida para pacientes con melanoma que tienen escaneos de imagen MC1R positivos. La nueva cohorte recibe una dosis de monoterapia de 1.5 mCi.
La expansión del ensayo sigue a resultados iniciales alentadores de la monoterapia presentados en el Congreso de la Sociedad de Investigación del Melanoma en octubre de 2024. Cabe destacar que esta cohorte incluye pacientes con metástasis cerebrales, respaldada por datos de imagen anteriores que muestran la captación del trazador en lesiones cerebrales. Una cohorte paralela que combina [212Pb]VMT01 con nivolumab comenzó en marzo de 2025.
Perspective Therapeutics (NYSE: CATX)는 MC1R 이미징 스캔이 양성인 멜라노마 환자를 위한 표적 알파 입자 치료제인 [212Pb]VMT01의 1/2a상 시험의 새로운 코호트에서 첫 번째 환자에게 투약을 시작했다고 발표했습니다. 새로운 코호트는 1.5 mCi의 단독 요법 용량을 받습니다.
이번 시험 확장은 2024년 10월 멜라노마 연구 학회에서 발표된 초기 단독 요법 결과가 고무적이어서 이루어졌습니다. 특히, 이 코호트에는 뇌 전이가 있는 환자가 포함되어 있으며, 이는 이전 이미징 데이터가 뇌 병변에서 추적자의 흡수를 보여줍니다. [212Pb]VMT01과 니볼루맙을 병합한 병행 코호트는 2025년 3월에 시작되었습니다.
Perspective Therapeutics (NYSE: CATX) a annoncé l'administration de la première dose au patient dans une nouvelle cohorte de son essai de phase 1/2a évaluant [212Pb]VMT01, une thérapie par particules alpha ciblée pour les patients atteints de mélanome ayant des scans d'imagerie MC1R positifs. La nouvelle cohorte reçoit une dose de monothérapie de 1,5 mCi.
L'expansion de l'essai fait suite à des résultats initiaux encourageants de la monothérapie présentés lors du Congrès de la Société de Recherche sur le Mélanome en octobre 2024. Notamment, cette cohorte comprend des patients avec des métastases cérébrales, soutenue par des données d'imagerie précédentes montrant l'absorption du traceur dans les lésions cérébrales. Une cohorte parallèle combinant [212Pb]VMT01 avec nivolumab a commencé en mars 2025.
Perspective Therapeutics (NYSE: CATX) hat die Dosierung des ersten Patienten in einer neuen Kohorte ihrer Phase 1/2a-Studie angekündigt, die [212Pb]VMT01 evaluiert, eine gezielte Alpha-Teilchen-Therapie für Melanom-Patienten mit positiven MC1R-Bildgebungsaufnahmen. Die neue Kohorte erhält eine Monotherapie-Dosis von 1,5 mCi.
Die Erweiterung der Studie folgt ermutigenden ersten Ergebnissen der Monotherapie, die im Oktober 2024 auf dem Kongress der Gesellschaft für Melanomforschung präsentiert wurden. Bemerkenswert ist, dass diese Kohorte Patienten mit Hirnmetastasen umfasst, unterstützt durch frühere Bilddaten, die die Traceraufnahme in Hirnläsionen zeigen. Eine parallele Kohorte, die [212Pb]VMT01 mit Nivolumab kombiniert, begann im März 2025.
- Expansion to include brain metastasis patients, addressing an important medical need
- Encouraging initial monotherapy results from Phase 1/2a study
- Parallel development of both monotherapy and combination therapy with nivolumab
- Still in early clinical development phase (Phase 1/2a)
- Efficacy and safety data not yet established at new dose level
Insights
Perspective Therapeutics' advancement to dosing a new cohort with [212Pb]VMT01 at 1.5 mCi represents methodical progress in their targeted alpha-particle therapy (TAT) approach for melanoma. The inclusion of patients with brain metastases is particularly significant, as these lesions affect 40-50% of advanced melanoma patients and typically present therapeutic challenges due to the blood-brain barrier.
The preliminary imaging data showing tracer uptake in brain metastases suggests this radiopharmaceutical might overcome traditional delivery limitations. TATs like [212Pb]VMT01 work by delivering short-range, high-energy alpha particles directly to cancer cells expressing the melanocortin 1 receptor (MC1R), potentially minimizing damage to surrounding healthy tissues.
The dual development strategy of evaluating both monotherapy and combination approaches with nivolumab (an established PD-1 inhibitor) is scientifically sound. Radiation can induce immunogenic cell death, potentially enhancing immunotherapy effectiveness through synergistic mechanisms. While the "encouraging initial monotherapy results" mentioned lack specific efficacy metrics, the progression to this next dosing cohort indicates acceptable safety at lower doses.
This represents standard clinical development in a Phase 1/2a trial primarily focused on safety and optimal dosing rather than definitive efficacy. The expansion to brain metastases patients addresses a critical unmet need, but conclusive therapeutic benefit remains to be demonstrated in later-stage trials.
This clinical milestone represents incremental yet important progress for Perspective Therapeutics' lead radiopharmaceutical program. For a micro-cap company (
The company's strategy of pursuing parallel monotherapy and combination approaches with nivolumab effectively hedges development risk while potentially accelerating the identification of the optimal therapeutic regimen. The inclusion of brain metastasis patients expands the addressable patient population and targets a high-value clinical need that could support premium pricing if eventually successful.
Targeted alpha therapies represent an emerging treatment modality with several companies pursuing similar approaches across various cancers. Perspective's differentiation stems from their focus on MC1R-positive melanoma and the lead-212 isotope platform. The company's earlier imaging studies demonstrating uptake in brain metastases provide scientific rationale for this expansion but don't guarantee therapeutic success.
Investors should note this remains a Phase 1/2a study primarily assessing safety and optimal dosing. While the previous presentation of "encouraging initial monotherapy results" supports continued development, specific efficacy signals weren't detailed in this announcement. The current advancement represents standard clinical progression without material deviation from expected development timelines or outcomes.
SEATTLE, April 11, 2025 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), as monotherapy in patients with histologically confirmed melanoma and positive melanocortin 1 receptor (MC1R) imaging scans.
Patients in this cohort are receiving [212Pb]VMT01 at 1.5 mCi as monotherapy. Initial results from the earlier monotherapy cohorts were previously presented at the 21st International Congress of the Society for Melanoma Research (SMR) in October 2024. A cohort administering a combination regimen with the immune checkpoint inhibitor nivolumab commenced dosing in March 2025.
"This further dose finding of [212Pb]VMT01 as monotherapy in patients with metastatic melanoma follows the encouraging initial monotherapy results from our Phase 1/2a study," commented Markus Puhlmann, Chief Medical Officer of Perspective. "This cohort allows enrollment of patients whose disease has spread to their brain, which is a common site of metastases and may add symptom burden for these patients. Previously generated images by an independent collaborator using [203Pb]VMT01 and [68Ga]VMT02 show tracer uptake by brain metastases which warrant exploring the therapeutic utility of [212Pb]VMT01 in these patients."
"The data from this part of the study will enable us to further develop our understanding of lower-dose radiopharmaceuticals in metastatic melanoma monotherapy and the contribution of this component in a combination regimen with immunotherapies in a variety of patients," said Thijs Spoor, Chief Executive Officer of Perspective. "We believe that concurrently studying VMT01 as monotherapy and in a combination regimen with nivolumab will help us identify the right path forward for this promising potential new medicine faster."
About [212Pb]VMT01
Perspective designed [212Pb]VMT01 to target and deliver 212Pb to tumor sites expressing MC1R, a protein that can be overexpressed in metastatic melanoma tumors.1 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 bloodstream 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 company pioneering advanced treatments 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 moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides 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 are in Phase 1/2a imaging and therapy trials in the U.S. for the treatment of metastatic melanoma and neuroendocrine tumors, respectively. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials 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 treatments 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, including the accrual of additional data for the Company's [212Pb]VMT01 program; the potential for [212Pb]VMT01 to be administered as monotherapy or in combination with other agents and for the Company to explore different dose levels in connection with its [212Pb]VMT01 trial; the potential for the Company to enroll in its [212Pb]VMT01 trial patients whose cancer has spread to their brain; the Company’s belief that data from the latest part of its [212Pb]VMT01 trial will enable the Company to “further develop [its] understanding of lower-dose radiopharmaceuticals in metastatic melanoma monotherapy and the contribution of this component in a combination regimen with immunotherapies in a variety of patients” and that concurrently studying [212Pb]VMT01 as monotherapy and in a combination regimen with nivolumab will help the Company “identify the right path forward” for [212Pb]VMT01 more quickly; 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; 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 moieties; the Company’s prediction that complementary imaging diagnostics that incorporate the same targeting moieties provide the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations; 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. 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.
Media and Investor Relations Contacts:
Perspective Therapeutics IR:
Annie J Cheng, CFA
ir@perspectivetherapeutics.com
Russo Partners, LLC
Nic Johnson
PerspectiveIR@russopr.com
1Su 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.
2Guidance for Industry Expedited Programs for Serious Conditions - Drugs and Biologics. https://www.fda.gov/media/86377/download?attachment. Accessed March 5, 2025.
3Cancer Stat Facts: Melanoma of the Skin. https://seer.cancer.gov/statfacts/html/melan.html. Accessed March 5, 2025.
4Ascierto 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
5Arance 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
6Chesney 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
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