Humanized Anti-CD40 antibody BSI-038 used in solid tumor population groups

Partnering objectives
Seeking a collaborative licensing opportunity with a company that has a strategic interest in the treatment of solid tumors
Field: Treatment of solid tumors

Technology and MOA
MOA: an agonist of the cell surface receptor CD40. This humanized anti-CD40 antibody binds to CD40 receptor and triggers the cellular proliferation and activation of antigen-presenting cells (APCs).

CD40 molecule is a potential target for cancer immunotherapy alone or combined with other treatments.
Agonistic CD40 mAb can have a cytotoxic effect on tumor by initiating ADCC, CMC, or programmed cell death

Marketing opportunity
Therapeutic targeting of CD40 by agonistic monoclonal antibodies (mAbs) aims to activate CD40+ APCs to effectively boost tumor-specific cytotoxic T cells to eliminate tumor cells. In principle it has the advantage of greater tumor specificity over other T cell activation approaches, such as checkpoint inhibition or indiscriminate T cell activation.

While agonistic CD40 mAbs have been developed for immunotherapy (Melero et al., 2007; Vonderheide and Glennie, 2013), their clinical efficacy has been limited (Chowdhury et al., 2014; Furman et al., 2010), suggesting that optimization is required.

Global market for Non-Small Cell Lung Cancer should reach $117.1 billion in 2025 from $33.16 billion in 2018 at a compound annual growth rate (CAGR) of 19.8%, from 2018 to 2025.

Differentiable treatment with potential to be first/ best in class
BSI-038 is a high-affinity humanized anti-CD40 monoclonal antibody with superior properties to the benchmark.

Indications
• Non-Small Cell Lung Cancer;
• Gastric Cancer;
• Head And Neck Cancer Squamous Cell Carcinoma;
• Malignant Mesothelioma;
• Metastatic Colorectal Cancer;
• Triple-Negative Breast Cancer (TNBC);

Data
Key parameters of humanized anti-CD40 antibody BSI-038 as compared to Selicrelumab:
• Exhibits 7-fold higher affinity to both human and cyno-CD40
• Shows 4-folds more potent cell-based agonist activity
• In vivo efficacy and PK/PD studies to be completed in Q1/2020
• Cell line development and CMC on-going and is expected to file IND in Q2/2021

Intellectual property
For discussion under CDA.