LaNova Medicines Announces the IND Approval of CCR8-targeting monoclonal antibody LM-108 by China NMPA

SHANGHAI, May 31, 2022 - LaNova Medicines announced that LM-108, its in-house developed CCR8-targeting humanized monoclonal antibody program has officially received the investigational new drug (IND) approval from the National Medical Products Administration (NMPA) of China.

This trial is an open-label, multi-center phase I/II study conducted in China to evaluate the safety, tolerability, and pharmacokinetics of LM-108 alone or in combination with anti-PD-1 monoclonal antibody in patients with advanced solid tumors. LM-108 is the first CCR8-targeting antibody to enter clinical stage in China. Previously, LM-108 received approval from the Australian Therapeutic Goods Administration (TGA) in November 2021, and received IND approval from the US Food and Drug Administration ( FDA ) in January 2022, and is currently being studied in the above two regions in an open-label, multicenter phase I/II study in patients with advanced solid tumors.

Dr. Crystal Qin, founder, chairman and CEO of LaNova Medicines, commented, "LM-108 is a CCR8-targeting monoclonal antibody developed by LaNova Medicines based on our proprietary multi-transmembrane protein antibody discovery platform, which can efficiently eliminate tumor-infiltrating Tregs through antibody dependent cell-mediated cytotoxicity (ADCC) without affecting peripheral regulatory T cells, thereby enhancing the immune killing effect on tumor cells. At the same time, this IND approval is also a re-verification of LaNova Medicines' R&D strategy, which reflects on our company's outstanding strength in translational medicine and clinical development. As the clinical trials progress, LM-108 is expected to demonstrate its therapeutic potential as a monotherapy and in combination therapies. It will bring new immunotherapy options to patients with advanced tumors."

About CCR8

CCR8 (chemokine receptor 8) belongs to the chemokine receptor subfamily and is also a member of multi-transmembrane proteins known as GPCRs. Previous studies have shown that CCR8 is less expressed in peripheral blood and normal tissue cells, but is specifically upregulated on the surface of infiltrating regulatory T cells (Treg) in tumor microenvironments such as breast cancer, colorectal cancer, and lung cancer. Antibodies targeting CCR8 can selectively mediate the clearance of tumor-infiltrating Tregs, thereby enhancing anti-tumor immunity and inhibiting tumor growth. At present, there are 4 drugs under clinical development targeting CCR8globally, and all of them are in the early clinical research phase. These include Bristol-Myers Squibb's BMS-986340, Gilead/Jounce's JTX-1811, Shionogi's S-531011, and LaNova Medicines’ LM-108.

About LaNova Medicines

LaNova Medicines is a clinical-stage innovative drug R&D company based in China and facing the world. It was founded in 2019 by senior personnel in the biomedical industry. With the mission of "respecting life and committing to innovation", the company focuses on the unmet therapeutic needs in the field of tumor immunity and tumor microenvironment, and focuses on the research and development of biological innovative drugs with the potential of "world's first" and "best in class". The company has full-chain comprehensive research and development capabilities, especially focusing on the research and development of biologic anti-tumor drugs targeting GPCRs and multiple transmembrane proteins. At present, LaNova Medicines has established a number of differentiated innovative drug pipelines with global competitiveness and independent property rights, and has successfully promoted many innovative drug products to the world's leading clinical stage.