Significant reduction of patient population needed for proof of efficacy trials can be achieved by using companion diagnostic screening
The tumor antigen recognized by AbGn-107 is present preferentially in a broad spectrum of epithelial-based malignancies. A companion diagnostic method of immunohistochemistry (IHC) has been developed by AbG, and was approved by the FDA for use in selecting more suitable patients as part of our Phase-I safety and proof of efficacy study. By pre-screening patients who possess the relevant and adequate target antigen, the patient population which is more likely to benefit from our target therapy can be pre-identified.
A high clinical success rate for targeting a clinically validated tumor antigen and utilizing AbG's novel hydrophilic self-immolative linker
AbG previously completed a phase-I trial in patients with gastric and colorectal cancers in both the US and Taiwan for a naked antibody specific for the same tumor-associated antigen as AbGn-107. A long-lasting stable disease has been observed in a few end-stage patients treated with the antibody alone. AbGn-107 showed significantly more potent and efficacious antitumor response than its naked antibody in animal tumor models. Together with specific companion diagnostics for pre-selecting patients having tumors with tumor-associated antigen expression, it is possible that a higher clinical success rate may be achievable. Furthermore, the unique design of the linker with improved biophysical properties confers greater drug stability and solubility that enhance the safety/efficacy profiles as well as pharmaceutical development (CMC) of AbGn-107.