Radiance Begins Phase 1 Trial Dosing for ROR-1 Targeted ADC in Cancer

BOSTON, MA, USA I April 15, 2025 I Radiance Biopharma, Inc., a clinical-stage biopharmaceutical firm specializing in Antibody Drug Conjugates (ADCs), has announced a significant development in its research efforts. The company has commenced dosing the first participant in China as part of a Phase 1 clinical trial for RB-164™ (SYS6005), a cutting-edge ADC targeting the ROR-1 protein.

This milestone is achieved through collaboration with CSPC Pharmaceutical Group, Radiance's development partner in China. Robert Brooks, JD, who serves as the Chief Executive Officer of Radiance, highlighted the importance of this step for the company and the RB-164™ project. Martin Olivo, MD, the Chief Medical Officer of Radiance, elaborated on the promising results seen in preclinical and non-human primate studies, indicating potential clinical benefits and manageable toxicity levels for patients with ROR-1 positive hematologic malignancies, such as Diffuse Large B-Cell Lymphoma, as well as solid tumors.

The Phase 1 clinical trial is designed to assess the safety, efficacy, and pharmacokinetics (PK) of RB-164™. This open-label study is being conducted by Radiance across multiple regions, including the U.S., Australia, and Europe. It targets patients suffering from hematologic cancers like lymphoma and advanced solid tumors characterized by high ROR-1 expression. The trial begins with a dose-escalation phase, which is followed by dose optimization and expansion phases to ensure comprehensive evaluation.

RB-164™ represents a next-generation advancement in ROR-1 ADCs. It utilizes an Fc-silenced monoclonal antibody and glutamine side chain-based conjugation to secure the linker-MMAE payload, preventing deconjugation. This site-specific conjugation aims to achieve a uniform Drug-to-Antibody ratio, enhancing both pharmacokinetic and toxicological profiles. Regulatory green lights were received from both China's National Medical Products Administration (NMPA) and the U.S. FDA for the Investigational New Drug (IND) application related to RB-164™.

Radiance Biopharma is dedicated to the development of antibody-based cancer therapeutics, focusing on unmet medical needs in cancer treatment. Their work includes both monospecific and bispecific ADCs. Besides RB-164™, the company is also advancing RB-201™, a HER2/TROP2 bispecific ADC currently in preclinical development stages. Radiance's ongoing efforts reflect their commitment to pioneering new treatment approaches in oncology.

This step forward with RB-164™ underscores Radiance's strategic focus on leveraging innovative biotechnology to address complex health challenges. As the study progresses, the company aims to gather critical data that could pave the way for new treatment options for patients battling cancer, thereby reinforcing their position in the biopharmaceutical landscape.