IntoCell, a company specializing in antibody-drug conjugate (ADC) platforms, announced on August 29 that it has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) of Korea for the clinical Phase 1 trial of its independently developed pipeline, ITC-6146RO.
Once the IND is approved, IntoCell plans to conduct a Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and initial antitumor efficacy of ITC-6146RO in patients with advanced or metastatic cancer who have failed standard treatments.
ITC-6146RO is a novel ADC drug candidate targeting B7-H3. High expression of B7-H3 has been reported in metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and triple-negative breast cancer (TNBC).
This candidate incorporates IntoCell's next-generation platform technologies, OHPAS (linker) and PMT (Payload Modification Technology), along with a highly potent drug from the Duocarmycin class.
A company representative stated, "We have demonstrated excellent efficacy and safety in preclinical studies," adding, "We have also achieved superior results in immune cell toxicity compared to ADCs based on existing technologies."
B7-H3 remains an area with no approved ADC drugs. Unlike many competitors who utilize camptothecin-class drugs, IntoCell is differentiating itself by applying the Duocarmycin class.
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