AstraZeneca Submits Clinical Application in China for AZD5492, a CD20×TCR×CD8 Trispecific Antibody for Cancer Therapy

Aug 17, 2024 08:55 CST Updated 08:55

AstraZeneca

Biopharmaceutical Manufacturer

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Today (August 17), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,AstraZeneca(AstraZeneca)AZD5492 Submitted for Clinical Trial in China and Accepted. Public information shows that this is aCD20×TCR×CD8 Trispecific Antibody, is produced byCD8-guided T-cell engager. This is the first time that this new drug candidate has been submitted for clinical trial in China.

Screenshot source:CDE Official Website

AZD5492 is an asymmetric trispecific monoclonal IgG1 antibody, which contains twoAnti-CD20The Fab domain, a VHH domain that binds to TCR, and a VHH domain that binds to the CD8 co-receptor.At the 2024 European Hematology Association (EHA) Annual Meeting held in June this year, a study on AZD5492 for the treatment of B-cell non-Hodgkin lymphomaPreclinical study data were released.

Structure of AZD5492 (Screenshot source: Reference 2)

This preclinical study explored the mechanism of action of AZD5492 in vitro and in vivo, and compared it withTraditionalCD3xCD20T-cell engager agentsBiological activity was compared.Research shows,Compared with traditional CD20xCD3T-cell engager(Compared to the conjunction and activation of CD4+ and CD8+ T cells), AZD5492 induces a certain degree of B cell killing by preferentially binding to CD8+ T cells, while reducing the activation of CD4+ T cells and associated cytokine production.AZD5492 Expected to Significantly Improve Treatment Outcomes in B-Cell Lymphoma, for further clinical evaluation of this candidate drugProvided strong biological evidence.

According toClinicalTrials.govAccording to the official website, AstraZeneca has registered a Phase 1/2 clinical study aimed at evaluating the safety, PK, PD, and efficacy of AZD5492 in patients with relapsed/refractory B-cell malignancies. The study is planned to be conducted across 19 centers in the United States, Australia, and other countries, with an enrollment target of 174 participants and an expected completion date of February 2028.

This timeAZD5492 Submits Clinical Application in China, Signaling the Entry of This Investigational New Drug into the Registration Phase in China.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Aug 17, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2]https://medicalinformation.astrazeneca-us.com/home/congress-pdf-viewer.html?pdfPath=https://d27mnwjqm5ztsa.cloudfront.net/4d4d150a-bf20-4c76-945a-ce2a670c3c99/4279b7e7-81a0-4332-88f6-dc56dd8182ab/4279b7e7-81a0-4332-88f6-dc56dd8182ab_source__v.pdf&pdfTitle=Pre-clinical%20development&documentNumber=305119

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