AstraZeneca's CD19×CD3 bispecific therapy for leukemia has been approved for clinical trials in China.
AstraZeneca has been approved to conduct clinical trials for treating leukemia in China. The company's new drug AZD0486 is intended for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). AZD0486 is a bispecific T-cell engager protein targeting CD19×CD3, which can guide T cells to tumor cells and kill them. Previously, AstraZeneca acquired TeneoTwo for approximately $1.27 billion, further diversifying its hematology pipeline. AstraZeneca is currently conducting clinical studies on AZD0486 in the United States to evaluate its safety and efficacy in the treatment of B-ALL and B-cell non-Hodgkin's lymphoma (B-NHL).
Zhitong App learned that on February 28th, the China National Medical Products Administration's Center for Drug Evaluation (CDE) website announced that Astrazeneca's Class 1 new drug AZD0486 has been approved for clinical trials, aiming to develop a treatment for relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Public information indicates that AZD0486 is a bispecific T-cell engager (TCE) targeting CD19×CD3. In July 2022, Astrazeneca acquired TeneoTwo company for approximately $1.27 billion, gaining access to their investigational product (previously known as TNB-486).
It is understood that one end of AZD0486 can bind to the CD19 antigen expressed on the surface of B cells, while the other end binds to the CD3 receptor on T cells, redirecting T cells to tumor cells and inducing T cells to kill tumor cells. In August 2022, Astrazeneca announced the completion of the acquisition of TeneoTwo company for over $1.2 billion. According to Astrazeneca's earlier press releases, this acquisition further diversifies the company's hematology pipeline to target a wide range of blood cancers with different therapeutic molecular types and mechanisms of action. Astrazeneca is currently developing AZD0486 for the treatment of B-ALL and B-cell non-Hodgkin's lymphoma (B-NHL).
According to information from the ClinicalTrials website, Astrazeneca is currently conducting a Phase 1/2 clinical trial in the United States to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in patients with r/r B-ALL who have received ≥2 prior lines of treatment; as well as a Phase 1 clinical trial to assess the efficacy and safety of AZD0486 in treating r/r B-NHL.
