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Actinium Pharmaceuticals, NCI Ink Research Agreement on Targeted Radiopharmaceutical

NEW YORK – Actinium Pharmaceuticals and the National Cancer Institute have partnered to develop the CD33-targeted radiotherapy Actimab-A as a blood cancer treatment including for TP53-mutated acute myeloid leukemia.

Under the terms of the Cooperative Research and Development Agreement (CRADA) announced by Actinium earlier this week, the NCI will act as the regulatory sponsor and oversee clinical trials involving Actimab-A. Actinium, for its part, will provide its radiotherapy to patients at participating trial sites as well as any necessary clinical trial support.

Through the CRADA, Actimab-A, which comprises an anti-CD33 monoclonal antibody, lintuzumab, linked to the radioisotope Actinium-225, will be available for clinical and nonclinical research to more than 2,000 institutions within the NCI-funded Experimental Therapeutics Clinical Trials Network (ETCTN) and the National Clinical Trials Network (NCTN). The Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN); the Southwest Oncology Group (SWOG); and the Alliance for Clinical Trials in Oncology will all have access to Actimab-A under the agreement. The investigational radiopharmaceutical will also be available to the MyeloMATCH program, an NCI/SWOG-led umbrella trial investigating personalized treatments for AML and myelodysplastic syndromes.

Actinium and the NCI hope to advance Actimab-A as either a monotherapy or in combination with other agents. For example, the Medical College of Wisconsin is evaluating Actimab-A plus chemotherapy in AML patients, including those with TP53 mutations.

"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," Actinium CEO and Chairman Sandesh Seth said in a statement. "NCI's sponsorship will also allow us to accelerate novel Actimab-A combinations and broaden its use in AML and other hematological indications, while the collaboration with NCI … will help preserve our balance sheet for additional corporate priorities."