Intocell Accelerates Global Phase 1 Clinical Trial of ADC Candidate 'ITC-6146RO'

Phase 1 Clinical Trial of Intocell's ADC Candidate ITC-6146RO Begins
First Patient Dosed, Marking Transition to Clinical-Stage and Accelerating Global Expansion

Intocell, a next-generation antibody-drug conjugate (ADC) platform company, announced on March 24 that it has successfully administered its first dose to a patient in the phase 1 clinical trial of its ADC drug candidate, ITC-6146RO. With this initial patient dosing as a milestone, Intocell is transitioning from a research and development-focused biotech company to a clinical-stage enterprise, accelerating its expansion into the global market.

The phase 1 clinical trial targets patients with solid tumors who have not responded to standard treatments or who have developed resistance. The trial is being conducted as a multi-center, open-label study. After confirming safety and tolerability during the dose-escalation phase, an appropriate dose will be determined, and the initial anti-tumor efficacy will be rigorously evaluated.

ITC-6146RO is an ADC candidate that targets 'B7-H3,' a protein highly expressed in various solid tumors. B7-H3 is gaining attention as a next-generation target antigen due to its limited expression in normal tissues but overexpression in cancer cells, thereby enhancing tumor selectivity. This candidate is designed to selectively attack cancer cells by conjugating a cytotoxic payload.

Notably, this candidate incorporates Intocell’s proprietary ADC platform technologies, 'OHPAS' and 'Payload Modulation Technology (PMT).' OHPAS is a linker technology designed to maintain stability in the bloodstream while releasing the drug selectively within tumors, and PMT optimizes the physicochemical properties of the payload to increase its efficacy inside cancer cells. Through these innovations, Intocell aims to achieve both precision in drug delivery and enhanced safety.

Building on its proprietary ADC platform, Intocell is developing multiple oncology pipelines, and based on the clinical results of ITC-6146RO, the company expects to demonstrate the clinical validity of its platform technology. At the same time, it anticipates accelerating discussions on technology transfer (L/O) and joint development with global pharmaceutical companies.

An Intocell representative stated, “This first patient dosing marks an important milestone, as it demonstrates that our ADC platform has entered the clinical stage. Through phase 1 clinical trials, we plan to rigorously verify safety and initial efficacy and expand into global development.”

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