IntoCell Receives FDA IND Approval for Advanced Solid Tumor Treatment 'ITC-6146RO'

IntoCell announced on November 27 that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its candidate treatment for advanced solid tumors, 'ITC-6146RO'.

ITC-6146RO is an antibody-drug conjugate (ADC) 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).

ITC-6146RO incorporates IntoCell's proprietary next-generation platform technologies, OHPAS (linker) and PMT (Payload Modification Technology), along with a highly potent drug from the duocarmycin class.

Notably, B7-H3 is an area where no ADC drugs have been approved yet. Unlike the typical use of the camptothecin class, IntoCell has differentiated itself by applying the duocarmycin class.

This clinical trial will enroll up to 102 patients with advanced or metastatic cancer who have failed standard of care (SoC) therapies. ITC-6146RO will be administered to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy.

The phase 1a study will assess dose escalation, while phase 1b will evaluate dose expansion. The recommended phase 2 dose will be determined during phase 1. In phase 1b, anti-tumor effects in mCRPC, NSCLC, and TNBC will be evaluated.

IntoCell stated, "With this FDA approval, our technological capabilities have once again been validated," adding, "We plan to accelerate growth focused on technology commercialization by strengthening our global business development capabilities, expanding technology transfer of our pipeline, and pursuing new partnerships."