The Company’s oncology pipeline is led by givastomig, a potential first-in-class and best-in-class, Claudin 18.2 X 4-1BB bispecific antibody. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Our oncology pipeline also features Ragistomig, a PD-L1 × 4-1BB bispecific antibody; and Uliledlimab, an anti-CD73 monoclonal antibody.
Givastomig
Givastomig [A Novel Claudin 18.2 and 4-1BB Bi-Specific Antibody] · Potential First-in-Class CLDN 18.2 x 4-1 BB Therapeutic · Potential Best-in-Class CLDN 18.2 x 4-1 BB Therapeutic · FDA Orphan Drug Designation · FDA Alignment on Potential Eligibility for an Accelerated Approval Pathway in 1L GEC Patients
Mechanism of Action
Conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed
Unique Molecular Design Balances Anti-Tumor Efficacy and Safety
- Highly Potent CLDN18.2 mAb
Binds to tumor cells with a wide range of CLDN18.2 expression - Silenced FC: IgG1
No ADCC or CDC, designed to minimize unintended systemic immune activation driven by FcgR-mediated 4-1BB clustering - Conditional 4-1 BB agonist
Localized T cell activation in TME leading to tumor killing and minimal 4-1BB-mediated liver toxicity or systemic immune response
MoA Video
Selected Publications
- Updated Safety, Efficacy and Biomarker Analysis from the Phase I Monotherapy Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC)
- A Phase Ib dose escalation study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with immunochemotherapy in HER2-negative, CLDN18.2-positive gastric, esophageal or gastro-esophageal junction adenocarcinoma
- Optimal dose estimation using an integrated approach from Phase I data of givastomig, a novel Claudin18.2×4-1BB bispecific antibody