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Actinium enters CRADA with NCI to develop Actimab-A to treat AML and other hematologic malignancies

New York
Tuesday, February 7, 2023, 14:00 Hrs  [IST]

Actinium Pharmaceuticals, Inc., a leader in the development of targeted radiotherapies, announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes for Health (NIH), to develop Actimab-A for the treatment of patients with acute myeloid leukaemia (AML) and other hematologic malignancies.

Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing additional support as needed. The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and other novel combinations, in line with Actinium's strategy of leveraging Actimab-A's targeted radiotherapy mechanism to elicit synergistic effects.

The CRADA studies will be overseen by NCI in collaboration with Actinium's clinical development team. Through the CRADA, Actimab-A will be available at over 2,000 clinical trial sites under the Experimental Therapeutics Clinical Trials Network (ETCTN) and the National Clinical Trials Network (NCTN) that includes leading oncology network groups such as Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN), Southwest Oncology Group (SWOG) and the Alliance for Clinical Trials in Oncology. Actimab-A studies may also be conducted through NCI's MyeloMATCH programme. NCI Cancer Therapy Evaluation Program (CTEP), which sponsors approximately two thirds of all combination cancer studies, will be accepting Letters of Intent (LOIs) or concepts for Phase 1, 2 or 3 studies of Actimab-A in AML and other haematological malignancies.

Sandesh Seth, Actinium's chairman and CEO, said, "We are incredibly honoured to be collaborating with NCI and excited that they share our vision for Actimab-A's potential for the treatment of AML and other blood cancers. The CRADA will allow Actimab-A's broad applicability to be fully studied and developed by leading oncology network groups as well as NCI's leading-edge MyeloMATCH program in ways Actinium could not do independently. NCI's sponsorship will also allow us to accelerate novel Actimab-A combinations and broaden its use in AML and other haematological indications, while the collaboration with NCI, who funds and maintains the largest centralized clinical trial support systems in the United States, will help preserve our balance sheet for additional corporate priorities."

Dr. Avinash Desai, chief medical officer of Actinium Pharmaceuticals, commented, "NCI's broad support under the CRADA is a strong encouragement for us to together explore Actimab-A's potential for the treatment of AML and other hematologic malignancies. As the only CD33 targeting radiotherapy in development, Actimab-A is uniquely positioned to address the challenges in treating relapsed or refractory AML patients who do not respond well to front line therapies and those whose disease stops responding to traditional cytotoxic or available targeted therapies. We are highly encouraged by the high rates of responses, minimal residual disease negativity and strong survival benefit at 1 and 2 years in heavily treated patients, including prior Venetoclax treatment and/or transplant, and those with adverse cytogenetics, including TP53 mutations, recently reported from the Actimab-A CLAG-M combination study. We look forward to working collaboratively with the NCI and all investigators through this CRADA to complete multiple clinical trials to further realize Actimab-A's therapeutic potential."

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet needs.


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