CLDN18.2 Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2024

CLDN18.2, also known as Claudin-18.2, is a protein that belongs to the claudin family, which are tight junction proteins involved in the formation of tight junctions between epithelial cells, which play a crucial role in maintaining the integrity and barrier function of epithelial tissues. CLDN18.2 is primarily expressed in the gastric mucosa and is highly specific to gastric epithelial cells. It has gained interest as a potential target for cancer therapy due to its overexpression in gastric and gastroesophageal junction (GEJ) cancers. The exact mechanism of action for CLDN18.2 inhibitors would depend on their specific design and mode of action. However, the general idea behind CLDN18.2 inhibitors is to target and block the function or expression of CLDN18.2 in cancer cells, particularly in gastric and GEJ cancers.

CLDN18.2 Inhibitors act by involving small molecules or monoclonal antibodies that could be designed to specifically bind to CLDN18.2, inhibiting its function and disrupting tight junction formation in cancer cells, which could lead to the disruption of the cancer cell's ability to maintain their integrity and limit their invasive potential. CLDN18.2 Inhibitors are used in the potential treatment of gastric cancers, biliary cancer, solid tumors, and pancreatic cancer, to name a few. Moreover, the rising incidence of gastrointestinal cancers and uplifting R&D investments in cancer research are the key drivers for the CLDN18.2 Inhibitors market. For instance, according to the American Cancer Society 2022, stomach cancer accounts for about 1.5% of all new cancers diagnosed in the US each year. Moreover, numerous industry players are developing innovative compounds to address the difficulties in therapy. For instance, Astellas Zolbetuximab (IMAB362) is currently under phase 3 clinical trial to treat gastric cancer in various stages of clinical studies.

Key Market Developments:

• In July 2023, Based on Astellas Pharma’s results from the SPOTLIGHT and GLOW trial, the USFDA accepted and granted Priority Review for the company Biologics License Application for Zolbetuximab, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma whose tumors are CLDN18.2-positive.

Drugs under the Pipeline for CLDN18.2 Inhibitors:

• Zolbetuximab (IMAB362)
• Osemitamab (TST001)
• ASKB589
• FL-301
• LM-102
• AB011
• ASP2138
• BNT141
• DR30303
• IBI360
• IBI389
• JS012
• LB4330
• M108
• MIL93
• PM1032
• PT886
• Q-1802
• QLS31905
• SG1906
• SPX-101
• TAC-Claudin 18.2
• ZL-1211
• Givastomig (TJ-CD4B)
• Gresonitamab (AMG 910)

Clinical Activity and Developments of CLDN18.2 Inhibitors:

Till July 2023, more than ten companies have approximately 29 molecules targetting many cancers. For these molecules, more than 15 clinical trials are being conducted and the majority are in phase-1, and phase-2 clinical trials by players across the globe. For instance,

• In June 2023, Astellas Pharma conducting phase 3, global, multi-center, double-blind, randomized, efficacy study of Zolbetuximab( IMAB362) plus mFOLFOX6 compared with placebo plus mFOLFOX6 as first-line treatment of subjects with claudin (CLDN)18.2-Positive, HER2-Negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.