Biocytogen Pharmaceuticals has announced a major breakthrough as its partner, NEOK Bio, secured US FDA clearance for its novel cancer therapy.

 

The investigational new drug (IND) application with FDA was actually for NEOK002, an EGFR/MUC1-targeting antibody-drug conjugate (ADC) aimed at solid tumors.

 

NEOK Bio plans to launch a Phase 1 clinical trial in the second quarter of 2026, with initial data expected in 2027. The IND clearance represents a key milestone for NEOK002, which is built on a bispecific antibody originally developed by Biocytogen and licensed in 2024. NEOK Bio says NEOK002 could deliver differentiated efficacy and safety compared with single-target ADC therapies.

 

Dr. Yuelei Shen, President and CEO of Biocytogen, said: “We are pleased to see one of our partnered molecules reach this important stage of development. This milestone further validates the quality, developability, and therapeutic potential of fully human bispecific antibodies discovered using our RenLite platform, which features a common light chain design. We look forward to the continued clinical advancement of the program.”

 

This development underscores Biocytogen’s growing influence in antibody-based drug innovation and highlights the promise of bispecific approaches for tackling challenging cancers.