General AML

FDA grants Investigational New Drug clearance for actimab-A in combination with CLAG-M for R/R AML patients

On 13th March 2018, the U.S. Food and Drug Administration (FDA) granted Investigational New Drug (IND) application clearance for the phase I trial of actimab-A in combination with cladribine, cytarabine, and filgrastim with mitoxantrone (CLAG-M) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML).1

Actimab-A, an antibody-drug conjugate (ADC), consists of the CD33-targeting monoclonal antibody lintuzumab and the alpha-emitting radioisotope actinium-225. Actimab-A targets CD33 (expressed on a majority of AML cells) via the antibody lintuzumab and delivers powerful actinium-225, which kills the AML cells. Actinium-225 releases high-energy alpha particles as it decays, which kills cancer cells.2

The IND approval allows the investigator’s led phase I study, which is assessing the safety and efficacy (based on response rates, percentage of patients receiving a bone marrow transplant and overall survival) of actimab-A in combination with CLAG-M in up to 18 R/R AML patients to proceed. The trial would be conducted at the Medical College of Wisconsin and would be led by principal investigator Dr. Sameem Abedin in collaboration with Dr. Ehab Atallah.1

  1. Nasdaq: Actinium Announces FDA Clearance of IND For Phase 1 trial of Actimab-A in Combination with CLAG-M for Patients with Relapsed or Refractory AML. 2018 Mar 13. [Accessed 2018 Mar 13].
  2. Hagemann U. B. et al. In Vitro and In Vivo Efficacy of a Novel CD33-Targeted Thorium-227 Conjugate for the Treatment of Acute Myeloid Leukemia. Mol Cancer Ther. 2016 Oct; 15(10): 2422–2431. DOI: 10.1158/1535-7163.MCT-16-0251. Epub 2016 Aug 17.