China-based Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Preliminary results from the Phase I study (NCT05164458) of IBI389 demonstrated promising efficacy in pancreatic ductal adenocarcinoma (PDAC) and the bispecific antibody is expected to evolve as a promising therapeutic option for PDAC in China and globally, says GlobalData.
IBI389 is an anti-CLDN18.2 T cell-engaging bispecific antibody that redirects T cells to tumor cells by binding both CLDN18.2 expressed on tumor cells and CD3 on T cells, inducing T cell-mediated cell killing. Preliminary results from 72 CLDN18.2-positive patients with advanced unresectable or metastatic PDAC showed encouraging efficacy even with relatively low expression of CLDN18.2. Safety was similar to that of the overall population (pancreatic carcinoma, gastric adenocarcinoma, advanced or metastatic solid tumors).
According to GlobalData’s Pharma Intelligence Center, the number of diagnosed prevalent cases of PDAC in urban China is expected to increase at an annual growth rate (AGR) of 5.71 per cent from 19,871 in 2023 to 25,777 in 2029.
Nadim Anwer, Analyst at GlobalData, comments: “Despite recent advances in therapeutic approaches to treat pancreatic cancer, along with the introduction of drugs with novel mechanisms of action, the unmet need remains high. IBI389, the world’s first bispecific antibody targeting CLDN18.2/CD3, could have a positive impact on the PDAC treatment landscape.”
PDAC is classified as an exocrine pancreatic cancer and is considered to be the most common type of pancreatic cancer, accounting for more than 85 per cent of all pancreatic cancers.
Currently, chemotherapy remains the mainstay of treatment across the first and second line for advanced pancreatic cancer. Most agents in development have varied safety and efficacy profiles and are aimed at treating advanced or metastatic patients in either the first- or second-line settings. Moreover, high clinical trial discontinuation and failure rates among late-stage agents highlight R&D challenges faced by companies in the pancreatic cancer disease space.
As per GlobalData’s Pharma Intelligence Center, there are only two bispecific antibodies targeting CLDN18.2/CD3 in clinical development, including Innovent’s asset. The second asset, AZD-5863 from AstraZeneca, is in Phase I/II clinical development for PDAC, and results are expected in December 2026. Innovent is also developing IBI343, an innovative anti-CLDN18.2 antibody-drug conjugate (ADC) for PDAC. Recently, IBI343 Phase I clinical data (NCT05458219) was presented at ASCO.
“With two assets targeting different mechanisms, Innovent would like to strengthen its position and deliver differentiated innovation for PADC, making it difficult for competitors. Innovent’s two promising assets with different mechanisms (CLDN18.2/CD3 and CLDN18.2 ADC) would bring a significant shift in current treatment approaches for PDAC, if successful in clinical trials and gaining approvals. Moreover, it would provide a competitive edge considering the high unmet need. Notably, with these innovative assets, the company can attract and expand its strategic collaborations with foreign players,” concludes Anwer.
Edits made by EP News Bureau
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