Actinium Pharmaceuticals Announces Initiation of Actimab-A Triplet Combination Frontline Trial Under NCI CRADA with Venetoclax and Taiho Oncology's Hypomethylating Agent ASTX-727 in Patients with Newly Diagnosed AML
Actinium Pharmaceuticals (NYSE: ATNM) has initiated a groundbreaking clinical trial under its CRADA with the National Cancer Institute, testing a first-ever triplet combination therapy for newly diagnosed AML patients. The trial (NCT06802523) will evaluate Actimab-A in combination with Venetoclax and ASTX-727.
Actimab-A, a humanized anti-CD33 antibody with Actinium-225 payload, will be combined with Venetoclax (a Bcl-2 inhibitor) and ASTX-727 (an oral hypomethylating agent). The study aims to assess Complete Remission rates and safety parameters, with initial clinical data expected in 2H:2025.
Previous Phase 1 trials demonstrated Actimab-A's mutation agnostic properties and synergistic potential. The company aims to establish Actimab-A as a backbone therapy for AML treatment, targeting over 100,000 patients with AML and other myeloid malignancies in the U.S. and major international markets.
Actinium Pharmaceuticals (NYSE: ATNM) ha avviato una sperimentazione clinica innovativa nell'ambito del suo CRADA con il National Cancer Institute, testando una terapia combinata tripla mai vista prima per pazienti con AML recentemente diagnosticati. Lo studio (NCT06802523) valuterà Actimab-A in combinazione con Venetoclax e ASTX-727.
Actimab-A, un anticorpo umanizzato anti-CD33 con carico di Actinium-225, sarà combinato con Venetoclax (un inibitore di Bcl-2) e ASTX-727 (un agente ipometilante orale). L'obiettivo dello studio è valutare i tassi di remissione completa e i parametri di sicurezza, con i dati clinici iniziali attesi nella seconda metà del 2025.
I precedenti studi di Fase 1 hanno dimostrato le proprietà agnostiche alle mutazioni di Actimab-A e il suo potenziale sinergico. L'azienda mira a stabilire Actimab-A come terapia di base per il trattamento dell'AML, mirando a oltre 100.000 pazienti con AML e altre neoplasie mieloidi negli Stati Uniti e nei principali mercati internazionali.
Actinium Pharmaceuticals (NYSE: ATNM) ha iniciado un ensayo clínico innovador bajo su CRADA con el Instituto Nacional del Cáncer, probando una terapia de combinación triple nunca antes vista para pacientes con AML recién diagnosticados. El ensayo (NCT06802523) evaluará Actimab-A en combinación con Venetoclax y ASTX-727.
Actimab-A, un anticuerpo humanizado anti-CD33 con carga de Actinium-225, se combinará con Venetoclax (un inhibidor de Bcl-2) y ASTX-727 (un agente hipometilante oral). El estudio tiene como objetivo evaluar las tasas de Remisión Completa y los parámetros de seguridad, con datos clínicos iniciales esperados para la segunda mitad de 2025.
Los ensayos de Fase 1 anteriores demostraron las propiedades agnósticas a mutaciones de Actimab-A y su potencial sinérgico. La empresa busca establecer Actimab-A como una terapia base para el tratamiento de AML, apuntando a más de 100,000 pacientes con AML y otras malignidades mieloides en los EE. UU. y en los principales mercados internacionales.
액티늄 제약 (NYSE: ATNM)은 국립암연구소와의 CRADA에 따라 혁신적인 임상 시험을 시작하였으며, 새로 진단된 AML 환자를 위한 최초의 삼중 조합 요법을 시험하고 있습니다. 이 시험 (NCT06802523)은 Actimab-A와 Venetoclax, ASTX-727의 조합을 평가할 것입니다.
Actimab-A는 Actinium-225 화물이 있는 인간화된 anti-CD33 항체로, Venetoclax (Bcl-2 억제제) 및 ASTX-727 (경구 저메틸화제)와 결합될 것입니다. 이 연구의 목표는 완전 관해율과 안전성 매개변수를 평가하는 것이며, 초기 임상 데이터는 2025년 하반기에 예상됩니다.
이전의 1상 시험에서는 Actimab-A의 돌연변이 비의존적 특성과 시너지 가능성을 입증했습니다. 회사는 Actimab-A를 AML 치료의 기본 요법으로 확립하고, 미국 및 주요 국제 시장에서 10만 명 이상의 AML 및 기타 골수 악성 종양 환자를 대상으로 하고자 합니다.
Actinium Pharmaceuticals (NYSE: ATNM) a lancé un essai clinique révolutionnaire dans le cadre de son CRADA avec le National Cancer Institute, testant une première thérapie combinée à trois médicaments pour les patients atteints de LMA nouvellement diagnostiqués. L'essai (NCT06802523) évaluera Actimab-A en combinaison avec Venetoclax et ASTX-727.
Actimab-A, un anticorps humanisé anti-CD33 avec une charge d'Actinium-225, sera associé à Venetoclax (un inhibiteur de Bcl-2) et ASTX-727 (un agent hypométhylant oral). L'étude vise à évaluer les taux de rémission complète et les paramètres de sécurité, avec des données cliniques initiales attendues dans la seconde moitié de 2025.
Les précédents essais de phase 1 ont démontré les propriétés agnostiques aux mutations d'Actimab-A et son potentiel synergique. L'entreprise vise à établir Actimab-A comme une thérapie de base pour le traitement de la LMA, ciblant plus de 100 000 patients atteints de LMA et d'autres malignités myéloïdes aux États-Unis et sur les principaux marchés internationaux.
Actinium Pharmaceuticals (NYSE: ATNM) hat eine bahnbrechende klinische Studie im Rahmen seines CRADA mit dem National Cancer Institute gestartet, die eine erstmalige dreifache Kombinationsbehandlung für neu diagnostizierte AML-Patienten testet. Die Studie (NCT06802523) wird Actimab-A in Kombination mit Venetoclax und ASTX-727 bewerten.
Actimab-A, ein humanisierter anti-CD33-Antikörper mit Actinium-225-Beladung, wird mit Venetoclax (einem Bcl-2-Inhibitor) und ASTX-727 (einem oralen hypomethylierenden Mittel) kombiniert. Ziel der Studie ist es, die Raten vollständiger Remission und Sicherheitsparameter zu bewerten, wobei erste klinische Daten im 2. Halbjahr 2025 erwartet werden.
Frühere Phase-1-Studien haben die mutationsagnostischen Eigenschaften und das synergistische Potenzial von Actimab-A demonstriert. Das Unternehmen strebt an, Actimab-A als Basistherapie für die AML-Behandlung zu etablieren, wobei über 100.000 Patienten mit AML und anderen myeloischen Malignitäten in den USA und wichtigen internationalen Märkten im Fokus stehen.
- First-ever triplet combination using targeted radiotherapy as backbone therapy in AML
- Expansion into frontline treatment significantly increases addressable market
- Previous Phase 1 trials showed positive safety profile and synergistic potential
- Convenient outpatient administration possible due to oral agents and no isolation requirements
- Strong investigator interest driven by compelling clinical results in over 150 patients
- Initial clinical data not available until second half of 2025
- Success in previous Ven-HMA treatments shows significant patient relapse rates
Insights
Actinium's initiation of this triplet combination trial marks a significant clinical advancement in AML treatment. This represents the first-ever use of targeted radiotherapy as a backbone therapy in a triplet regimen for newly diagnosed AML patients, potentially addressing critical limitations of current standards of care.
The trial design is particularly noteworthy - combining Actimab-A with two established therapies (Venetoclax and ASTX-727) that are already approved but face limitations. While Venetoclax+HMA combinations have improved frontline AML outcomes, many patients still experience poor responses or rapid relapse. Actimab-A's alpha-particle payload causes double-strand DNA breaks with no known resistance mechanisms, potentially addressing this limitation.
Two key elements differentiate this approach: First, by targeting CD33 (expressed in nearly all AML patients), Actimab-A provides a mutation-agnostic approach that could overcome high-risk features like TP53 mutations where current therapies struggle. Second, the combination maintains outpatient treatment convenience as both Venetoclax and ASTX-727 are oral, and Actimab-A doesn't require isolation.
Previous Phase 1 data showing Actimab-A can synergize with Venetoclax by depleting MCL-1 (a resistance mechanism) provides mechanistic rationale for this combination. Moving into frontline treatment substantially expands Actimab-A's potential patient population beyond relapsed/refractory settings.
This clinical trial initiation represents a material catalyst for Actinium Pharmaceuticals that significantly advances their strategic pipeline positioning. The company's CRADA with the NCI provides both validation and resource efficiency for developing Actimab-A, particularly valuable for a company with Actinium's modest
The trial expands Actimab-A's potential into the lucrative frontline AML setting, dramatically increasing its addressable market opportunity. Importantly, Actinium has positioned Actimab-A as the only CD33-targeted radiotherapy in development for myeloid malignancies, creating a differentiated approach within a competitive landscape where previous CD33-targeting approaches have faced challenges.
This triplet combination strategy is commercially astute - by combining with established therapies like Venetoclax (AbbVie/Roche) and ASTX-727 (Taiho/Otsuka), Actinium creates potential partnership pathways while targeting known treatment limitations. The alpha-particle approach offers mechanistic advantages over traditional antibody-drug conjugates or chemotherapies.
While data readout isn't expected until 2H:2025, establishing Actimab-A as a potential backbone therapy across multiple treatment settings could create significant long-term value. The company's strategy to generate additional preclinical data and initiate more trials throughout 2025 suggests an accelerating development timeline that could drive further valuation catalysts if successfully executed.
- Represents first ever triplet combination using targeted radiotherapy as a backbone therapy in AML with initial clinical data expected in 2H:2025
- Expansion into frontline setting greatly expands potential addressable patient opportunity for Actimab-A
- Triplet combination supported by previously completed Phase 1 trials of Actimab-A + Venetoclax and Actimab-A + CLAG-M demonstrating Actimab-A's mutation agnostic and synergistic potential
Dr. Avinash Desai, Actinium's Chief Medical Officer, commented, "We are incredibly excited that the first Actimab-A trial initiated under our CRADA with the NCI is this triplet combination with Venetoclax and Taiho's ASTX-727. While Ven-HMA has positively impacted outcomes in AML, a significant number of patients have poor responses or relapse quickly resulting in dismal outcomes. We believe Actimab-A's potentially synergistic, and mutation agnostic mechanism of action can improve clinical outcomes for these patients by producing deeper remissions, including measurable residual disease negativity, that are more durable. Due to its mutation agnostic mechanism, Actimab-A can overcome high-risk features, such as TP53 mutations, and has demonstrated the ability to improve outcomes in these patients where Ven-HMA has had limited success. This triplet regimen can be conveniently administered in the outpatient setting as Venetoclax and ASTX-727 are both oral agents and Actimab-A does not require isolation given that it is an alpha-particle emitter. We are eager to collaborate with NCI on this important study to evaluate earlier intervention with a CD33 targeted radiotherapy in patients with AML."
Actimab-A in combination with Venetoclax was previously studied in a multi-center Phase 1 trial. The combination was shown to be well tolerated with manageable adverse events. Preclinical studies showed that Actimab-A can synergize with Venetoclax by depleting MCL-1, which mediates Venetoclax resistance.
Sandesh Seth, Actinium's Chairman & CEO, said, "We believe 2025 will be a transformational year for Actimab-A and that the initiation of this triplet trial is a significant catalyst. It is our objective to establish Actimab-A as a backbone therapy across the treatment continuum of AML and other myeloid malignancies leveraging the broad expression of CD33 and the mutation agnostic Ac-225 payload. Driven by the compelling clinical results in over 150 patients in multiple treatment settings and the high visibility of our NCI CRADA, we are seeing strong enthusiasm from investigators for Actimab-A. As the only CD33 targeted radiotherapy in development for myeloid malignancies, we are focused on capitalizing on the tremendous opportunity to improve outcomes for a significant patient population that continues to have high unmet medical needs that are not addressed by current therapies. Over the course of 2025, we expect to generate preclinical data and initiate additional clinical trials that will further differentiate Actimab-A and demonstrate material progress in establishing Actimab-A as a first-in-class backbone radiotherapy for the over 100,000 patients with AML and other myeloid malignancies in the
About Actinium Pharmaceuticals, Inc.
Actinium is a pioneer in developing targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic ARC as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) including measurable residual disease (MRD) negativity with improved survival outcomes. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for in the
For more information, please visit: https://www.actiniumpharma.com/
Forward-Looking Statements
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
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