Lyvgen Biopharma Submits IND Application in China for LVGN6051, a First-in-Class CD137 Agonist Antibody

Source | Medical Horizon

On August 12, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration publicly announced that Lijin Biotechnology had submitted an investigational new drug application for its Class 1 biologic LVGN6051 monoclonal antibody injection, and the application was accepted. LVGN6051 is a CD137 agonist antibody currently undergoing Phase I clinical trials in the United States. Previously, this product entered into a collaboration with Merck Sharp & Dohme (MSD)’s PD-1 inhibitor Keytruda to evaluate the efficacy of the combination therapy in treating various malignant tumors.

Source of screenshot: CDE official website

CD137 is a member of the tumor necrosis factor (TNF) receptor family, also known as TNFRSF9 or 4-1BB. Induced by lymphocyte activation, it functions as a co-stimulatory immune checkpoint molecule. CD137 is expressed on activated T cells, with higher expression levels observed on CD8+ T cells compared to CD4+ T cells. The most characteristic function of CD137 is its co-stimulatory effect on T cell activation. Its cross-linking enhances T cell proliferation, IL-2 secretion, survival, and cytolytic activity. Furthermore, CD137 can augment immune responses to eliminate tumors in mice.

According to the official website of Lijin Biotechnology, after administration, LVGN6051 binds to and activates CD137 expressed on various leukocyte subsets, including activated T lymphocytes and natural killer (NK) cells. This enhances CD137-mediated signaling, induces cytokine production, and promotes T cell-mediated anti-tumor immune responses. Unlike first-generation CD137 agonistic antibodies that have entered clinical trials, LVGN6051 selectively activates CD137 locally within the tumor microenvironment, thereby reducing immune-related adverse effects in normal tissues.

▲Mechanism of Action of LVGN6051 (Screenshot source: Lijin Biotechnology official website)

In June this year, Lijin Biotechnology announced a clinical trial collaboration agreement with a subsidiary of Merck Sharp & Dohme (MSD) to evaluate the efficacy of LVGN6051 in combination with MSD’s PD-1 inhibitor Keytruda (pembrolizumab) for the treatment of various malignant tumors, including lung cancer, melanoma, gastrointestinal cancers with deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H), and lymphoma.

Currently, Lijin Biotechnology is conducting Phase I clinical trials of LVGN6051 as monotherapy or in combination with anti-PD-1 antibodies in the United States. This marks the first time that the product’s application for clinical trials has been submitted and accepted in China, and the company plans to officially launch the Phase I clinical trial in China in the first quarter of 2021.

▲ Lijin Biotechnology’s Pipeline Under Development (Screenshot source: Lijin Biotechnology official website)

Lijin Biotechnology, founded by Dr. Wang Jieyi in 2016, centers on its globally innovative pipeline of tumor immune agonistic antibodies. Currently, its investigational pipeline includes six innovative candidate drugs. Among them, the CD40-targeting agonistic antibody LVGN7409 is in the preparation stage for clinical trial application.

References

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 12, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=21#

[2]Lyvgen Announces Clinical Trial Collaboration With MSD. Retrieved June 9, 2020, from https://www.businesswire.com/news/home/20200609005863/en/Lyvgen-Announces-Clinical-Trial-Collaboration-MSD

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