AstraZeneca Submits Clinical Application in China for CD19/CD3 Bispecific Antibody AZD0486 Targeting Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Dec 15, 2023 11:52 CST Updated 11:52

AstraZeneca

Biopharmaceutical Manufacturer

On December 15 (today), the CDE website announced that AstraZeneca's AZD0486 has been submitted for clinical trials, aiming to evaluate the safety and efficacy of AZD0486 in adolescent and adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia.

AZD0486 is a novel, off-the-shelf, fully human CD19xCD3 IgG4 bispecific antibody, rationally designed with a high-affinity, heavy-chain-only αCD19 domain and a silenced Fc region (Figure 1). It not only precisely binds to target cells and induces T-cell-mediated cytotoxicity but also reduces non-specific activation and minimizes adverse effects while providing a longer half-life suitable for intermittent dosing. Additionally, its unique low-affinity αCD3 portion reduces cytokine release and Treg cell activation, achieving high efficacy with low toxicity.

AZD0486 Drug Structure

At the 65th American Society of Hematology (ASH) Annual Meeting, held from December 9 to 12, 2023, AstraZeneca presented clinical trial data for TNB-486 (AZD0486), demonstrating the broad potential of its hematology pipeline.

This ASH presentation disclosed updated safety data following the implementation of dual dose escalation in the ongoing Phase I FIH study. This is a Phase 1/2, global multicenter, open-label, single-arm, dose-escalation and dose-optimization study of AZD0486, aimed at evaluating the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B-ALL who have received ≥ treatment. A total of 65 patients with B-NHL were enrolled, including 16 patients who failed CAR-T cell therapy and 3 patients who failed CD20 monoclonal antibody therapy.

Study Design

The research results showAZD0486 demonstrated favorable safety and efficacy in R/R B-NHL, and as a leading CD19xCD3 bispecific antibody, it showcased impressive therapeutic outcomes.

AstraZeneca Partial Pipeline

Previous Recommendations

Full Review of Hengrui Medicine's Biologics Pipeline

Overview of Chinese Pharmaceutical Enterprises

Shiyao Group Biopharmaceutical Technology Platform and Pipeline Review

An Overview of the Competitive Landscape for Popular ADC Targets in China

Click "PharmResearch Network" below to follow more exciting content.