BT-02: A First-in-Class ITPRIPL1-Targeting Monoclonal Antibody for Advanced Solid Tumors

1. Executive Summary

BT-02 is an investigational, first-in-class monoclonal antibody developed by Shanghai BioTroy Therapeutics Co., Ltd. (also known as Shanghai Baiquan Biotechnology Co., Ltd.). It is designed to treat advanced solid tumors by targeting Inositol 1,4,5-trisphosphate receptor-interacting protein-like 1 (ITPRIPL1), a novel immune checkpoint. ITPRIPL1 has been identified as a ligand for CD3ε, a critical component of the T-cell receptor complex. By binding to CD3ε, ITPRIPL1 impedes T-cell activation, thereby enabling tumor immune evasion. BT-02, by neutralizing ITPRIPL1, aims to restore T-cell anti-tumor activity.

Preclinical studies have demonstrated promising efficacy and a good safety profile for BT-02, leading to Investigational New Drug (IND) application approvals from both the U.S. Food and Drug Administration (FDA) in September 2023 and the China National Medical Products Administration (NMPA) in January 2024. BioTroy Therapeutics, in collaboration with Fudan University, has established a robust global intellectual property portfolio around this novel target and its therapeutic modulation.

Currently, BT-02 is being evaluated in parallel Phase 1/2 clinical trials in both the United States (NCT06404905) and China (CTR20240083) for patients with advanced solid tumors. These open-label studies are assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of BT-02. The development of BT-02 represents a significant "from 0 to 1" innovation, focusing on a novel mechanism that may address tumors unresponsive to existing PD-1/PD-L1 inhibitors. The successful clinical development of BT-02 could offer a new therapeutic paradigm in cancer immunotherapy.

2. Introduction to BT-02