BSI-077 Partnering Opportunity, Humanized Anti-Claudin 18.2 Antibody for Gastric Cancer

CLAUDIN 18.2 mAb  Mechanism of Action
Claudin 18.2 is a small transmembrane protein with 4 transmembrane domains and two extracellular loops, is overexpressed in a significant proportion of gastric cancers and esophageal adenocarcinomas. The restricted expression makes it a promising target for the treatment of gastric and esophageal adenocarcinoma.

Anti-Claudin 18.2 antibody specifically binds to splice variant of claudin 18 (CLDN18.2), and stimulates the immune system to mount a cytotoxic T-lymphocyte (CTL) response against GC-18.2-expressing tumor cells resulting in decreased tumor cell proliferatio

Market Opportunity:
It is the fourth most commonly occurring cancer in men and the seventh most commonly occurring cancer in women. A major fraction of gastric cancer has been linked to variety of pathogenic infections including but not limited to Helicobacter pylori (H. pylori) or Epstein Barr virus (EBV). Strategies are being pursued to prevent gastric cancer development such as H. pylori eradication, which has helped to prevent significant proportion of gastric cancer. Today, treatments have helped to manage this disease and the 5-year survival for stage IA and IB tumors treated with surgery are between 60 and 80%. However, patients with stage III tumors undergoing surgery have a dismal 5-year survival rate between 18 and 50% depending on the dataset. These figures indicate the need for more effective molecularly driven treatment strategies.

Zolbetuximab’s net present value (NPV) is estimated about 471 billion USD by GlobalData

Differentiable Treatment With Potential To Be First/Best in Class
BSI077 is a highly selective humanized anti-Claudin 18.2 monoclonal antibody molecule with significant higher internalization activity and higher cell-binding especially in claudin18.2 low expression cancer cells than benchmark –Zolbetuximab (Astellas Pharma Inc) – currently in phase 3 clinical trial

Potential Indications
Adenocarcinoma of the Gastroesophageal Junction; Gastric Cancer

Program Highlights
Key parameters of humanized anti-Claudin 18.2 antibody BSI077 as compared to Zolbetuximab:

• Eight-Fold higher internalization activity than Zolbetuximab
• Higher cell-binding than Zolbetuximab, especially in claudin18.2 low expression cancer cells
• Potent in vitro ADCC activity than Zolbetuximab

Development Stage
Pre-clinical candidates for ADC

Mode of Adminstration
Injectable

Intellectual Property
For discussion under CDA