Roche Submits IND Application in China for PD-1/LAG-3 Bispecific Antibody RO7247669

Source: Pharma Insights

According to a public disclosure by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), the RO7247669 injection, currently under development by Roche, has submitted a clinical trial application in China and was accepted on July 2. Public information indicates that RO7247669 is a bispecific antibody targeting PD-1 and LAG-3, with a Phase 1/2 clinical trial currently underway globally. This marks the first clinical trial application for this drug in China.

Screenshot source: CDE official website

Bispecific antibodies are a class of antibodies capable of specifically binding to two distinct antigens. This therapeutic approach harnesses T cells from the patient's immune system to eliminate tumors. One end binds to antigens on the surface of cancer cells, while the other end binds to T cell receptors on the surface of T cells, thereby recruiting T cells to the vicinity of cancer cells and activating T cell-mediated cytotoxicity against the tumor cells.

RO7247669 is a bispecific antibody developed by Roche that targets PD-1 and LAG-3. The PD-1/PD-L1 immune checkpoint is a highly prominent and widely recognized target in the field of cancer immunotherapy. Meanwhile, LAG-3 has also emerged as one of the most promising frontier targets in cancer immunotherapy, and the development of LAG-3-targeting antibodies has achieved significant progress this year.

LAG-3 stands for Lymphocyte-Activation Gene 3. It is an immune checkpoint protein expressed on the surface of effector T cells and regulatory T cells (Tregs), which modulates signaling pathways in T lymphocytes and antigen-presenting cells (APCs) and plays a critical role in adaptive immune responses. Although LAG-3 and PD-1 mediate distinct signaling pathways, they may exert synergistic effects, leading to effector T cell exhaustion.

According to publicly available information on ClinicalTrials.gov, Roche is conducting multiple clinical trials to evaluate the safety and efficacy of RO7247669, with indications including metastatic melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, and advanced hepatocellular carcinoma. According to the CDE website, this marks the first clinical trial application for RO7247669 in China.

References:

[1] Center for Drug Evaluation, National Medical Products Administration (CDE). Retrieved July 2, 2021, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2] ClinicalTrials.gov website. From: https://clinicaltrials.gov/ct2/results?cond=&term=RO7247669&cntry=&state=&city=&dist=

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