AstraZeneca's CD19/CD3 Bispecific Antibody AZD0486 Granted Clinical Trial Approval in China for Follicular Lymphoma with 96% Overall Response Rate

Nov 16, 2024 08:48 CST Updated 08:48

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

On November 15, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration showed that AstraZeneca（AstraZeneca）The Class 1 new drug AZD0486, developed by AstraZeneca, has been granted two clinical trial implied permissions, intended for the treatment ofPreviously Untreated Follicular Lymphoma in Adults；Having received at least two lines or more of systemic treatmentAdult Relapsed/Refractory Follicular Lymphoma。

Public information shows,AZD0486It is one of AstraZeneca's research products.Bispecific T-cell engager targeting CD19/CD3, the next generation of T-cell engagers。This is the first approval for clinical use in China for the indication of follicular lymphoma (FL).In AstraZeneca's recently published clinical study, the product was used forPatients with Relapsed/Refractory FL（R/R FL）Showed an overall response rate (ORR) of up to 96% during treatmentThe press release stated that the product is expected to enhance the treatment of lymphoma patients in current clinical practice.

Screenshot source: CDE official website

AZD0486One end can bind to the CD19 antigen expressed on the surface of B cells, and the other end can bind to the CD3 receptor on the surface of T cells., therebyRedirect T cells to tumor cells, inducing T cell-mediated killing of tumor cells.In August 2022, AstraZeneca announced the completion of the acquisition of TeneoTwo for a total amount exceeding $1.2 billion.Acquisition，Thereby obtaining the latter's product under research(Previously known as TNB-486)。

Research shows,AZD0486Containing a unique low-affinity anti-CD3 fragment designed to reduce cytokine release,While retaining the effective cytotoxicity of T cells against malignant B cells.The silenced Fc region prevents non-specific binding and antibody-dependent cellular cytotoxicity, and has a long half-life suitable for intermittent dosing.。

At this year's American Society of Hematology (ASH) Annual Meeting, AstraZeneca announced clinical results from several of its hematology pipeline products. Results from one Phase I clinical trial showed,Patients with relapsed/refractory follicular lymphoma (R/R FL) showed a high response to AZD0486 at doses of 2.4 mg and above, with an overall response rate (ORR) of up to 96% and a complete response (CR) rate of 85%., and the negative rate of minimal residual disease (MRD) in patients is very high.

According toClinicalTrialsOfficial website, AstraZeneca is conducting a study evaluating AZD0486 in combination with rituximab for the treatmentPreviously untreated follicular lymphomaThe Phase 3 clinical study, as well as a study targetingRelapsed or Refractory B-cell Non-Hodgkin Lymphoma (including Follicular Lymphoma)Phase 1 Clinical Study.

In China,AZD0486TreatmentRelapsed or Refractory B-Cell Acute Lymphoblastic LeukemiaPreviously received CDE clinical trialTacit Consent。The approval of the new IND in China means that it has also ushered in new R&D progress in China.

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Nov 16, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024. Retrieved November 7, 2024 from https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-showcases-strength-of-haematology-portfolio-and-pipeline-at-ash-2024.html

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