Drug intelligence / Profile preview

GNC-035

Development stage
Phase 2
Lead developer
SystImmune
Modality
Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous
01

Overview

GNC-035 is a tetra-specific antibody immunotherapeutic designed to target four distinct molecules involved in tumor growth and immune regulation: receptor tyrosine kinase-like orphan receptor 1 (ROR1), CD3, 4-1BB (CD137), and programmed cell death ligand 1 (PD-L1). By simultaneously binding to ROR1 on tumor cells, PD-L1 on tumor cells, CD3 on T cells, and the costimulatory receptor 4-1BB on activated T lymphocytes, GNC-035 crosslinks cytotoxic T lymphocytes with ROR1-expressing cancer cells. This results in potent CTL-mediated lysis of tumor cells. The engagement of 4-1BB provides additional co-stimulation to T-cells, enhancing their anti-tumor activity. Blocking PD-L1 prevents it from inhibiting T-cell activation via PD-1, further promoting immune-mediated destruction of cancerous cells. GNC-035 is being developed primarily for hematological malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia as well as certain solid tumors including breast cancer[2][5][6]. The drug is currently under clinical investigation by SystImmune and Sichuan Baili Pharmaceutical.

02

Targets

ROR1 (Receptor tyrosine kinase-like orphan receptor 1)TNFRSF9 (CD137 extracellular domain)CD3 (T-cell surface glycoprotein CD3)CD274 (Programmed cell death protein 1 ligand 1)

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