Actinium Pharmaceuticals Announces Research Collaboration with Memorial Sloan Kettering to Support Further Clinical Expansion of Actimab-A's Backbone Therapy Strategy
Actinium Pharmaceuticals (NYSE: ATNM) has announced a research collaboration with Memorial Sloan Kettering Cancer Center to expand Actimab-A's therapeutic applications. The partnership focuses on studying Actimab-A in combination with targeted therapies, particularly FLT3 and menin inhibitors, and assessing its activity in AML patient-derived samples.
Actimab-A has shown positive clinical results in high-risk relapsed and refractory AML patients, including those with TP53 gene mutation, prior Venetoclax treatment, and bone marrow transplant. The therapy demonstrates synergy with various inhibitors targeting mutations present in significant portions of AML cases: NPM1 and KMT2A (30%), FLT3 (25-30%), and IDH1&2 (10-20%).
The company is advancing Actimab-A into a pivotal Phase 2/3 trial in combination with CLAG-M chemotherapy for relapsed/refractory AML, and in newly diagnosed AML with Venetoclax and ASTX-727. Additionally, Actinium is developing Actimab-A for solid tumor indications, with planned trials combining it with KEYTRUDA® and OPDIVO® in HNSCC and NSCLC.
Actinium Pharmaceuticals (NYSE: ATNM) ha annunciato una collaborazione di ricerca con il Memorial Sloan Kettering Cancer Center per espandere le applicazioni terapeutiche di Actimab-A. La partnership si concentra sullo studio di Actimab-A in combinazione con terapie mirate, in particolare inibitori di FLT3 e menin, e sulla valutazione della sua attività in campioni derivati da pazienti con AML.
Actimab-A ha mostrato risultati clinici positivi in pazienti con AML ad alto rischio, recidivanti e refrattari, inclusi quelli con mutazione del gene TP53, trattamento precedente con Venetoclax e trapianto di midollo osseo. La terapia dimostra sinergia con vari inibitori che mirano a mutazioni presenti in porzioni significative dei casi di AML: NPM1 e KMT2A (30%), FLT3 (25-30%) e IDH1&2 (10-20%).
L'azienda sta portando avanti Actimab-A in uno studio clinico cruciale di Fase 2/3 in combinazione con la chemioterapia CLAG-M per AML recidivante/refrattaria, e nei casi di AML recentemente diagnosticati con Venetoclax e ASTX-727. Inoltre, Actinium sta sviluppando Actimab-A per indicazioni di tumori solidi, con studi pianificati che lo combinano con KEYTRUDA® e OPDIVO® in HNSCC e NSCLC.
Actinium Pharmaceuticals (NYSE: ATNM) ha anunciado una colaboración de investigación con el Memorial Sloan Kettering Cancer Center para expandir las aplicaciones terapéuticas de Actimab-A. La asociación se centra en estudiar Actimab-A en combinación con terapias dirigidas, particularmente inhibidores de FLT3 y menin, y en evaluar su actividad en muestras derivadas de pacientes con AML.
Actimab-A ha mostrado resultados clínicos positivos en pacientes con AML de alto riesgo, en recaída y refractarios, incluidos aquellos con mutación del gen TP53, tratamiento previo con Venetoclax y trasplante de médula ósea. La terapia demuestra sinergia con varios inhibidores que apuntan a mutaciones presentes en porciones significativas de los casos de AML: NPM1 y KMT2A (30%), FLT3 (25-30%) e IDH1&2 (10-20%).
La empresa está avanzando Actimab-A en un ensayo pivotal de Fase 2/3 en combinación con la quimioterapia CLAG-M para AML en recaída/refractaria, y en AML recién diagnosticada con Venetoclax y ASTX-727. Además, Actinium está desarrollando Actimab-A para indicaciones de tumores sólidos, con ensayos planificados que lo combinan con KEYTRUDA® y OPDIVO® en HNSCC y NSCLC.
액티늄 제약 (NYSE: ATNM)은 액티맙-A의 치료 응용을 확장하기 위해 메모리얼 슬로안 케터링 암 센터와 연구 협력을 발표했습니다. 이 파트너십은 FLT3 및 메닌 억제제를 포함한 표적 치료와의 병용에서 액티맙-A를 연구하고 AML 환자 유래 샘플에서의 활성을 평가하는 데 중점을 두고 있습니다.
액티맙-A는 TP53 유전자 돌연변이, 이전 베네토클락스 치료 및 골수 이식을 포함한 고위험 재발 및 불응성 AML 환자에서 긍정적인 임상 결과를 보여주었습니다. 이 요법은 AML 사례의 상당 부분에서 발견되는 돌연변치를 표적으로 하는 다양한 억제제와 시너지를 나타냅니다: NPM1 및 KMT2A (30%), FLT3 (25-30%), IDH1&2 (10-20%).
회사는 재발/불응성 AML을 위한 CLAG-M 화학요법과 병용하여 액티맙-A를 2/3상 주요 시험으로 진행하고 있으며, 베네토클락스와 ASTX-727을 사용하여 새로 진단된 AML에서도 진행하고 있습니다. 또한, 액티늄은 HNSCC 및 NSCLC에서 KEYTRUDA® 및 OPDIVO®와 병용할 계획으로 액티맙-A를 고형 종양 적응증으로 개발하고 있습니다.
Actinium Pharmaceuticals (NYSE: ATNM) a annoncé une collaboration de recherche avec le Memorial Sloan Kettering Cancer Center pour élargir les applications thérapeutiques d'Actimab-A. Ce partenariat se concentre sur l'étude d'Actimab-A en combinaison avec des thérapies ciblées, en particulier les inhibiteurs de FLT3 et de menin, et sur l'évaluation de son activité dans des échantillons dérivés de patients atteints de LMA.
Actimab-A a montré des résultats cliniques positifs chez des patients atteints de LMA à haut risque, en rechute et réfractaires, y compris ceux présentant une mutation du gène TP53, un traitement antérieur par Venetoclax et une greffe de moelle osseuse. La thérapie démontre une synergie avec divers inhibiteurs ciblant des mutations présentes dans une partie significative des cas de LMA : NPM1 et KMT2A (30 %), FLT3 (25-30 %) et IDH1&2 (10-20 %).
L'entreprise fait avancer Actimab-A dans un essai pivot de phase 2/3 en combinaison avec la chimiothérapie CLAG-M pour LMA en rechute/réfractaire, et dans la LMA nouvellement diagnostiquée avec Venetoclax et ASTX-727. De plus, Actinium développe Actimab-A pour des indications de tumeurs solides, avec des essais prévus le combinant avec KEYTRUDA® et OPDIVO® dans HNSCC et NSCLC.
Actinium Pharmaceuticals (NYSE: ATNM) hat eine Forschungskooperation mit dem Memorial Sloan Kettering Cancer Center angekündigt, um die therapeutischen Anwendungen von Actimab-A zu erweitern. Die Partnerschaft konzentriert sich auf die Untersuchung von Actimab-A in Kombination mit zielgerichteten Therapien, insbesondere FLT3- und Menin-Inhibitoren, sowie auf die Bewertung seiner Aktivität in aus AML-Patienten gewonnenen Proben.
Actimab-A hat positive klinische Ergebnisse bei hochriskanten, rezidivierenden und refraktären AML-Patienten gezeigt, einschließlich solcher mit TP53-Gene Mutation, vorheriger Venetoclax-Behandlung und Knochenmarktransplantation. Die Therapie zeigt Synergie mit verschiedenen Inhibitoren, die auf Mutationen abzielen, die in signifikanten Teilen der AML-Fälle vorhanden sind: NPM1 und KMT2A (30%), FLT3 (25-30%) und IDH1&2 (10-20%).
Das Unternehmen bringt Actimab-A in eine entscheidende Phase 2/3-Studie in Kombination mit der CLAG-M-Chemotherapie für rezidivierende/refraktäre AML und in neu diagnostizierte AML mit Venetoclax und ASTX-727. Darüber hinaus entwickelt Actinium Actimab-A für Indikationen bei soliden Tumoren, mit geplanten Studien, die es mit KEYTRUDA® und OPDIVO® in HNSCC und NSCLC kombinieren.
- Expansion into solid tumor market through combinations with established immunotherapies KEYTRUDA® and OPDIVO®
- Demonstrated efficacy in high-risk AML patients with various mutations
- Advancing to pivotal Phase 2/3 trials
- Potential market opportunity of over 100,000 patients across myeloid malignancies
- Strategic collaboration with prestigious Memorial Sloan Kettering Cancer Center
- Clinical data results not expected until second half of 2025
- Success in solid tumor applications still unproven
- Faces competition from established treatments in AML therapy space
Insights
Actinium's new research collaboration with Memorial Sloan Kettering Cancer Center represents a strategic expansion of their Actimab-A development program that could significantly enhance the company's clinical pipeline. This partnership specifically targets two important research objectives: studying Actimab-A with targeted therapies like FLT3 and menin inhibitors, and evaluating activity in patient-derived AML samples.
What makes this collaboration particularly valuable is how it builds upon Actimab-A's demonstrated mutation-agnostic profile, which has shown efficacy in difficult-to-treat AML subtypes, including those with TP53 mutations, prior Venetoclax treatment, and previous bone marrow transplants. The company is pursuing a "backbone therapy" strategy—positioning Actimab-A as a foundation treatment that can be combined with various targeted therapies to address multiple AML genetic profiles.
The market opportunity cited by management (over 100,000 patients with myeloid malignancies) represents a substantial commercial target. Importantly, Actinium has multiple clinical development paths already in motion, including a Phase 2/3 trial combining Actimab-A with CLAG-M chemotherapy and a collaboration with the NCI studying Actimab-A with Venetoclax and ASTX-727.
The expansion into solid tumors by targeting myeloid-derived suppressor cells (MDSCs) significantly broadens Actimab-A's potential applications beyond hematological malignancies. The planned combination trials with PD-1 inhibitors like KEYTRUDA and OPDIVO in head and neck and lung cancers represent high-value indications with substantial unmet needs.
This collaboration between Actinium and MSKCC focuses on a scientifically compelling approach using targeted alpha radiotherapy. Actimab-A delivers Actinium-225, which produces lethal double-strand DNA breaks in CD33-expressing cells—a mechanism that bypasses many common resistance pathways in AML treatment. The absence of known resistance or repair mechanisms for alpha-particle damage represents a significant advantage in treating refractory disease.
The focus on combination strategies is particularly important. By pairing Actimab-A with targeted therapies addressing specific mutations like FLT3 (present in 25-30% of AML cases), menin inhibitors for NPM1 mutations and KMT2A rearrangements (~30% of cases), and IDH1/2 inhibitors (10-20% of cases), Actinium could potentially address a substantial portion of the AML patient population with precision medicine approaches.
The expansion into solid tumors by targeting CD33+ myeloid-derived suppressor cells represents an innovative approach to enhance immunotherapy efficacy. MDSCs are known to create an immunosuppressive tumor microenvironment that limits checkpoint inhibitor effectiveness. The head-to-head trial design against established standards (KEYTRUDA or OPDIVO alone) in HNSCC and NSCLC will provide clear evidence of any incremental benefit from adding Actimab-A.
The collaboration with MSKCC's leukemia and early drug development teams provides Actinium with access to world-class expertise in translational research and patient-derived models, which should accelerate clinical development pathways and potentially increase success probability for these combination approaches.
Actimab-A has demonstrated a mutation agnostic profile with positive clinical results in high-risk relapsed and refractory (r/r) AML patients including those with a TP53 gene mutation, prior Venetoclax treatment and prior bone marrow transplant (BMT). Additionally, Actimab-A has demonstrated mechanistic synergy with improved antileukemic activity and /or tumor control with FLT3 inhibitors, menin inhibitors for NPM1 mutant and KMT2A rearrangement and IDH1&2 inhibitors in preclinical studies. NPM1 and KMT2A are present in approximately
Sandesh Seth, Actinium's Chairman and CEO, said, "In 2025 we are reimagining and revitalizing our Actimab-A program leveraging its mutation agnostic, backbone therapy profile. This collaboration with MSKCC will further expand and support novel Actimab-A combinations with targeted therapies like FLT3 and menin inhibitors in AML. As we have demonstrated in combination with CLAG-M, Actimab-A has the potential to improve patients' outcomes via its novel and differentiated mechanism to target radiosensitive AML blasts and produce lethal double strand DNA breaks via the Actinium-225 payload for which there are no known resistance or repair mechanisms. We are eager to execute this collaboration and look forward to generating important data from AML patient derived models. Our goal is to address the unmet needs of over 100,000 patients with myeloid malignancies across the treatment journey with Actimab-A, which represents a multi-billion-dollar market opportunity. With recently initiated trials, this exciting research collaboration and clinical data expected in the second half of 2025, we believe we are making great progress to achieve our goal."
Actimab-A is Actinium's lead radiotherapeutic that delivers Actinium-225, a potent alpha-emitter radioisotope payload that can produce lethal double strand DNA breaks to kill targeted cells that express CD33. CD33 is expressed ubiquitously in AML and in other myeloid malignancies, giving Actimab-A backbone therapy potential. Actimab-A is being advanced into a pivotal Phase 2/3 in combination with the chemotherapy regimen CLAG-M in patients with relapsed or refractory AML and in newly diagnosed AML in combination with Venetoclax and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). Actinium is also developing Actimab-A for solid tumor indications by targeting myeloid derived suppressor cells (MDSCs), CD33 expressing immune cells, which are overexpressed in the tumor microenvironment that can limit the efficacy of PD-1 checkpoint immunotherapies and are associated with poor outcomes. Actinium's solid tumor program is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with the PD-1 checkpoint inhibitors KEYTRUDA® versus KEYTRUDA® alone, and Actimab-A with OPDIVO® versus OPDIVO® alone initially in HNSCC or Head and Neck Squamous Cell Carcinoma and NSCLC or Non-Small Cell Lung Cancer with a separate trial for each indication.
About Actinium Pharmaceuticals, Inc.
Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, 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) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. 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. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA® and OPDIVO® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. 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 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.
Investors:
investorrelations@actiniumpharma.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-announces-research-collaboration-with-memorial-sloan-kettering-to-support-further-clinical-expansion-of-actimab-as-backbone-therapy-strategy-302406589.html
SOURCE Actinium Pharmaceuticals, Inc.
FAQ
What are the main objectives of ATNM's collaboration with Memorial Sloan Kettering?
What mutation types can Actimab-A target in AML patients?
What are the upcoming clinical trials for ATNM's Actimab-A?
When will ATNM release new clinical data for Actimab-A?
