Radiance Announces First Patient Dosing in Phase 1 Clinical Trial of its Next Generation ROR-1 Targeted ADC for Hematologic and Solid Malignancies

BOSTON, April 15, 2025 (GLOBE NEWSWIRE) -- Radiance Biopharma, Inc. (“Radiance” or the “Company”), a clinical stage biopharmaceutical company advancing Antibody Drug Conjugates (‘ADCs’), today announced that the first patient in China has been dosed in the Phase 1 clinical trial of RB-164™ (SYS6005), a next-generation antibody-drug-conjugate (ADC) targeting ROR-1.

“The initiation of the Phase 1 clinical trial being conducted by our development partner CSPC Pharmaceutical Group in China is a significant milestone for Radiance and RB-164™ (SYS6005),” said Robert Brooks, JD, Chief Executive Officer of Radiance.

“The preclinical and non-human primate studies suggest RB-164™ has the potential to translate into meaningful clinical benefits with acceptable toxicity for patients with ROR-1 positive hematologic cancers such as Diffuse Large B-Cell Lymphoma and solid tumors,” said Martin Olivo, MD, Chief Medical Officer of Radiance.

The Phase 1 portion of the open label study which will be conducted by Radiance in the U.S., Australia and Europe will evaluate the safety, efficacy and pharmacokinetics (PK) of RB-164™ in participants with hematologic cancers such as lymphoma and advanced solid tumors that are associated with high ROR-1 expression. The Phase 1 clinical trial initiates with dose escalation followed by dose optimization and expansion.

About RB-164™
RB-164™ is a next generation ROR-1 ADC which employs an Fc-silenced monoclonal antibody, glutamine side chain-based conjugation to prevent deconjugation of the linker-MMAE payload and site specific conjugation to deliver a homogeneous Drug-to-Antibody distribution and thereby an improved pharmacokinetic and toxicology profile. An IND application for RB-164™ (SYS6005) has been cleared by China's National Medical Products Administration (NMPA) and the U.S. FDA.

About Radiance
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics for the treatment of cancer and other unmet medical needs, including monospecific and bispecific Antibody Drug Conjugates. In addition to RB-164™, Radiance is developing RB-201™, a HER2/TROP2 Bispecific ADC which is currently in preclinical stages. For more information on Radiance visit www.radiancebiopharma.com.

INVESTOR CONTACT:
Ola Soderquist, CPA, CMA, CM&AA
Chief Financial Officer
Radiance Biopharma, Inc.
Ola.Soderquist@radiancebiopharma.com
Investorrelations@radiancebiopharma.com

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