AbGn-107 is an antibody equipped with AbG’s linker-payload being developed by AbGenomics International designed to targets novel tumor-associated antigens on the surface of certain stomach, pancreatic, and colorectal cancers.
The targeting antibody in AbGn-107 is conjugated with a potent toxin through a cleavable linker which is only cleaved inside the tumor cells.
Furthermore, the targeting antibody can be internalized once it binds to cancer cells where the concentrated cytotoxin efficiently kills the cancer cells.
In pre-clinical trials, AbGn-107 demonstrated a superior antitumor efficacy in at least four established xenograft tumor models. In these trials, researchers achieved complete remission (CR) in the mice bearing large established tumors. Furthermore, the novel trial drug appeared to be safe and well-tolerable in non-human primates (NHP) toxicity studies. There were no signs of liver toxicity or thrombocytopenia that frequently were observed by other antibody-drug conjugates.
Targets
AbGn-107 binds to approximately 50%, 50%, 25% of stomach, pancreatic, and colorectal tumors, respectively.
According to the American Cancer Society:
- Stomach cancer is the fifth most common cancer in the world and is the third leading cause of cancer death worldwide;
- 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;
- Colorectal cancers accounts for about 3% of all cancers in the US and about 7% of cancer deaths.
These statistics highlight the existing unmet need, confirming the need for more effective therapies and strategies that can improve the survival and Quality of Life (QoL).
Phase I trial
AbGenomics is initiating a Phase I proof of concept clinical trial for the treatment of patients with advanced gastrointestinal cancers. The Phase I dose escalation with cohort expansion clinical study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AbGn-107 therapy in patients with chemo-refractory, locally advanced, recurrent, or metastatic gastric, colorectal, or pancreatic cancer.
AbGenomics expects to enroll approximately 54 patients in the study at multiple clinical sites across the country.
Competitive Advantage
According to researchers at AbGenomics, 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 Immuno-histochemistry (IHC) has been developed by AbGenomics International. The U.S. Food and Drug Administration (FDA) agreed with the company to use the companion diagnostic for selecting suitable patients in their Phase I safety and proof of efficacy study. Pre-screening patients who express the relevant and adequate target antigen, helps researchers to pre-identified patients that benefit most from treatment with AbGn-107.
Last Editorial Review: November 9, 2016
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