Perspective Therapeutics Announces First Patient Dosed with [212Pb]VMT01 in Combination with Nivolumab in a Phase 1/2a Study of MC1R-Positive Metastatic Melanoma
Perspective Therapeutics (NYSE AMERICAN: CATX) has announced the dosing of the first patient in a new cohort of their Phase 1/2a trial combining [212Pb]VMT01, their targeted alpha-particle therapy (TAT), with Bristol Myers Squibb's nivolumab (Opdivo®) for MC1R-positive metastatic melanoma patients.
The new cohort will receive [212Pb]VMT01 at 1.5 mCi alongside nivolumab, following earlier cohorts where [212Pb]VMT01 was administered as monotherapy. Initial results from previous cohorts, presented at the Society for Melanoma Research Congress in October 2024, showed promising outcomes with:
- No dose-limiting toxicities observed
- Early signs of anti-tumor activity in heavily pretreated patients
The company aims to explore how lower-dose radiopharmaceuticals can be optimized when combined with immunotherapies to potentially enhance both safety and efficacy for patients with treatment options.
Perspective Therapeutics (NYSE AMERICAN: CATX) ha annunciato la somministrazione del primo paziente in una nuova coorte del loro studio clinico di fase 1/2a che combina [212Pb]VMT01, la loro terapia a particelle alfa mirata (TAT), con il nivolumab di Bristol Myers Squibb (Opdivo®) per pazienti con melanoma metastatico positivo per MC1R.
La nuova coorte riceverà [212Pb]VMT01 a 1,5 mCi insieme al nivolumab, dopo le coorti precedenti in cui [212Pb]VMT01 è stato somministrato come monoterapia. I risultati iniziali delle coorti precedenti, presentati al Congresso della Society for Melanoma Research nell'ottobre 2024, hanno mostrato risultati promettenti con:
- Nessuna tossicità limitante la dose osservata
- Segni precoci di attività anti-tumorale in pazienti fortemente pretrattati
L'azienda mira a esplorare come i radiofarmaci a dose ridotta possano essere ottimizzati quando combinati con le immunoterapie per potenzialmente migliorare sia la sicurezza che l'efficacia per i pazienti con opzioni di trattamento.
Perspective Therapeutics (NYSE AMERICAN: CATX) ha anunciado la dosificación del primer paciente en una nueva cohorte de su ensayo de fase 1/2a que combina [212Pb]VMT01, su terapia dirigida de partículas alfa (TAT), con el nivolumab de Bristol Myers Squibb (Opdivo®) para pacientes con melanoma metastásico positivo para MC1R.
La nueva cohorte recibirá [212Pb]VMT01 a 1.5 mCi junto con nivolumab, tras las cohortes anteriores donde [212Pb]VMT01 se administró como monoterapia. Los resultados iniciales de cohortes anteriores, presentados en el Congreso de la Sociedad de Investigación sobre Melanoma en octubre de 2024, mostraron resultados prometedores con:
- No se observaron toxicidades limitantes de dosis
- Signos tempranos de actividad antitumoral en pacientes con tratamientos previos intensivos
La empresa tiene como objetivo explorar cómo los radiofármacos a dosis más bajas pueden ser optimizados cuando se combinan con inmunoterapias para potencialmente mejorar tanto la seguridad como la eficacia para pacientes con opciones de tratamiento.
Perspective Therapeutics (NYSE AMERICAN: CATX)는 MC1R 양성 전이성 흑색종 환자를 위한 Bristol Myers Squibb의 니볼루맙(Opdivo®)과 함께 [212Pb]VMT01, 그들의 표적 알파 입자 치료(TAT)를 결합한 1/2a상 임상시험의 새로운 집단에서 첫 환자 투여를 발표했습니다.
새로운 집단은 이전 집단에서 [212Pb]VMT01이 단독 요법으로 투여된 이후, 니볼루맙과 함께 1.5 mCi의 [212Pb]VMT01을 받게 됩니다. 2024년 10월 멜라노마 연구 학회에서 발표된 이전 집단의 초기 결과는 다음과 같은 유망한 결과를 보여주었습니다:
- 관찰된 용량 제한 독성 없음
- 강하게 전처리된 환자에서 초기 항종양 활동의 징후
회사는 저용량 방사성 의약품이 면역 요법과 결합될 때 최적화될 수 있는 방법을 탐구하여 치료 옵션이 있는 환자에게 안전성과 효능을 모두 향상시킬 수 있는 가능성을 모색하고자 합니다.
Perspective Therapeutics (NYSE AMERICAN: CATX) a annoncé la dose du premier patient dans une nouvelle cohorte de son essai de phase 1/2a combinant [212Pb]VMT01, leur thérapie ciblée par particules alpha (TAT), avec le nivolumab (Opdivo®) de Bristol Myers Squibb pour les patients atteints de mélanome métastatique positif pour MC1R.
La nouvelle cohorte recevra [212Pb]VMT01 à 1,5 mCi en association avec le nivolumab, après des cohortes antérieures où [212Pb]VMT01 a été administré en monothérapie. Les résultats initiaux des cohortes précédentes, présentés au Congrès de la Society for Melanoma Research en octobre 2024, ont montré des résultats prometteurs avec:
- Aucune toxicité limitante de dose observée
- Signes précoces d'activité antitumorale chez des patients fortement prétraités
L'entreprise vise à explorer comment les radiopharmaceutiques à faible dose peuvent être optimisés lorsqu'ils sont combinés avec des immunothérapies afin de potentiellement améliorer à la fois la sécurité et l'efficacité pour les patients ayant des options de traitement.
Perspective Therapeutics (NYSE AMERICAN: CATX) hat die Dosierung des ersten Patienten in einer neuen Kohorte ihrer Phase 1/2a-Studie bekannt gegeben, die [212Pb]VMT01, ihre gezielte Alpha-Teilchen-Therapie (TAT), mit Nivolumab (Opdivo®) von Bristol Myers Squibb für MC1R-positive metastasierte Melanom-Patienten kombiniert.
Die neue Kohorte wird [212Pb]VMT01 in einer Dosis von 1,5 mCi zusammen mit Nivolumab erhalten, nachdem in früheren Kohorten [212Pb]VMT01 als Monotherapie verabreicht wurde. Erste Ergebnisse aus früheren Kohorten, die auf dem Kongress der Society for Melanoma Research im Oktober 2024 präsentiert wurden, zeigten vielversprechende Ergebnisse mit:
- Keine dosislimitierenden Toxizitäten beobachtet
- Frühe Anzeichen von antitumoraler Aktivität bei stark vorbehandelten Patienten
Das Unternehmen zielt darauf ab, zu erkunden, wie niederdosierte Radiopharmazeutika optimiert werden können, wenn sie mit Immuntherapien kombiniert werden, um möglicherweise sowohl die Sicherheit als auch die Wirksamkeit für Patienten mit Behandlungsoptionen zu verbessern.
- No dose-limiting toxicities observed in Phase 1/2a trial
- Early signs of anti-tumor activity demonstrated in heavily pretreated patients
- Expansion of treatment protocol to include combination with established immunotherapy drug Opdivo
- Still in early clinical trial phases (1/2a)
- Efficacy data from combination therapy not yet available
SEATTLE, March 17, 2025 (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, 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), 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 in combination with nivolumab, a PD-1 blocking antibody developed and marketed by Bristol Myers Squibb as Opdivo®. Patients in earlier cohorts received [212Pb]VMT01 as monotherapy. Initial results from the earlier cohorts were previously presented at the 21st International Congress of the Society for Melanoma Research (SMR) in October 2024.
“The initial results from our Phase 1/2a study of [212Pb]VMT01 are particularly encouraging for investigating this combination," commented Markus Puhlmann, Chief Medical Officer of Perspective. "The data presented at the Society for Melanoma Research highlight the promising safety profile of [212Pb]VMT01, with no dose-limiting toxicities observed, and early signs of anti-tumor activity in patients who have received multiple lines of prior treatment. These findings provide a strong foundation for further exploration of [212Pb]VMT01 in combination with immune checkpoint inhibitors, where we believe its dual mechanism of action can be harnessed to improve patient outcomes.”
“The data from this next part of the study will enable us to further develop our understanding of how lower-dose radiopharmaceuticals can be optimized in combination with immunotherapies,” said Thijs Spoor, Chief Executive Officer of Perspective. “We are hopeful that this approach will enhance patient outcomes by improving both safety and efficacy, particularly for those with limited treatment options.”
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 (FDA) 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 moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, 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 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 treatment applications for cancers throughout the body; expectations regarding the advancement of and learnings from the Company's clinical development programs, including [212Pb]VMT01 as monotherapy and in combination with immune checkpoint inhibitors; 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 safety profile and efficacy of [212Pb]VMT01 in combination with immune checkpoint inhibitors and the potential of such treatment to enhance patient outcomes; 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; 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 opportunity to personalize treatment and optimize patient outcomes using the Company's complementary imaging diagnostics that incorporate the same targeting moieties; 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; 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
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