IntoCell, a corporation specializing in antibody-drug conjugate (ADC) platforms, announced on the 29th that it has submitted a clinical trial plan (Investigational New Drug application) to the Ministry of Food and Drug Safety (MFDS) for its self-developed pipeline 'ITC-6146RO' to enter phase 1 clinical trials.
IntoCell plans to conduct a phase 1 clinical trial evaluating safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor effects targeting patients with progressive or metastatic cancer who have failed standard treatment as soon as it receives IND approval.
ITC-6146RO is an ADC candidate drug targeting B7-H3. B7-H3 has been reported to have high expression rates in metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC).
This candidate drug applies IntoCell's self-developed next-generation platform technologies OHPAS (linker) and PMT (Payload Modification Technology) alongside Duocarmycin class high-efficacy drugs. B7-H3 is an area with no approved ADC drug yet, and unlike many competitors who utilize camptothecin class drugs, IntoCell is attempting differentiation by applying the Duocarmycin class.
A representative from IntoCell noted, 'We have demonstrated excellent efficacy and safety in preclinical studies, and we have also obtained superior results in immune cell toxicity compared to conventional technology-based ADCs.'