AbGn-107

Therapeutic Area

Product Overview
AbGn-107, an antibody equipped with AbG's linker-payload, targets novel tumor-associated antigens on the surface of certain gastrointestinal (GI) cancers including stomach, biliary system, pancreas, intestine and rectum. The targeting antibody is conjugated with a potent toxin through a cleavable linker which could only be cleaved inside the tumor cells. The targeting antibody can be internalized once it binds to cancer cells where the concentrated toxin efficiently kills the cancer cells. AbGn-107 demonstrated a superior antitumor efficacy in at least six established xenograft tumor models. With only few injections, complete eradication can be achieved in the mice bearing large established tumors. Most importantly, safe and well-tolerable profiles have shown in NHP toxicity studies. There were no signs of liver toxicity or thrombocytopenia that frequently were observed in other ADCs.

AbGn-107 binds to approximately 40-50% of pancreatic, gastric and biliarycancers and 20-25% of colorectal cancers. Pancreatic cancer is the fourth-leading cause of death from cancer in the US. The 5-year surviving rate of pancreatic cancer is merely about 6%, the lowest rate among all the major cancers. Gastric cancer is the fifth most common cancer in the world and is the third leading cause of cancer death worldwide. These frightening statistics highlight the need for more effective therapies and strategies that can improve the survival and quality of life.

As the dose-escalation part of AbGn-107 phase I study is going well, the company is commencing the dose expansion part to explore preliminary efficacy of AbGn-107 therapy in patients with chemo-refractory, locally advanced, recurrent, or metastatic gastric, biliary, pancreatic, or colorectal cancer. AbGenomics expects to enroll approximately 116 patients in the study at multiple clinical sites in both US and Taiwan.
Competitive Advantage of AbGn-107

01

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.

02

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.

Indication

Gastric, Pancreatic, Biliary and Colorectal Cancer

1

  • PRECLINAICAL

  • PHASE I

    Phase I

  • PHASE IIA

  • PHASE IIB

  • PHASE III

  • MARKET

Introduction

AbGn-107, an antibody drug conjugate (ADC) equipped with a potent toxin utilizing a cleavable linker, shows superior hydrophilicity, plasma stability and cytotoxicity.

The ADC binds to novel tumor-associated antigens on the surface of certain gastrointestinal cancer cells. The targeting AbGn-107 can be internalized once it binds to cancer cells, allowing the toxin to be released and kill the cancer cells efficiently. A Phase I safety and proof of efficacy clinical study of AbGn-107 for the treatment of advanced stomach, pancreatic, biliary and colorectal cancers is ongoing.

Tumor antigens recognized by AbGn-107 are present preferentially on epithelial based malignancies. A companion diagnostic test has been developed, and is agreed by the FDA to use for selecting suitable patients in clinical study. By pre-screening patients for adequate antigen expression on the tumor cell, we can better identify a patient population that is more likely to benefit from our target therapy.

AbGenomics expects to enroll approximately 80 patients at multiple clinical sites in both US and Taiwan.

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