Drug intelligence / Profile preview

KY-0301

Development stage
Phase 2
Lead developer
Novatim Immune Therapeutics
Modality
Small Molecules, Nanobodies (VHH) → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

KY-0301 is a **nanobody-based bispecific antibody-drug conjugate (ADC)** targeting both *mesenchymal epithelial transition factor receptor (MET)* and *epidermal growth factor receptor (EGFR)*. The drug is engineered with reduced EGFR affinity and a truncated EGFR arm to minimize EGFR-driven toxicity in normal tissues. Upon binding to MET and EGFR on tumor cells, KY-0301 is internalized and releases its cytotoxic payload, monomethyl auristatin E (MMAE), which inhibits tubulin polymerization, blocking cell division and inducing cell death. The platform is designed to improve tumor delivery and reduce off-target effects. Developed using Novatim Immune Therapeutics’s proprietary TPEBEN platform, it is distinguished as the world’s first nanobody-based bispecific ADC and features a high drug-to-antibody ratio (DAR) purity of 98%. The drug is currently under clinical investigation for use in various advanced and metastatic solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer, gastric cancer, and others[1][3][7][9][10].

02

Targets

TUBB (Tubulin (alpha and beta subunits))MET (Mesenchymal-epithelial transition factor receptor)EGFR (Epidermal growth factor receptor)

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