BOSTON, Mass, March 31, 2025 (GLOBE NEWSWIRE) -- Radiance Biopharma, Inc. (“Radiance” or the “Company”), a clinical stage biopharmaceutical company advancing Antibody Drug Conjugates (‘ADCs’), today announced that the U.S. Food and Drug Administration (“FDA”) has cleared its Investigational New Drug (“IND”) application for RB-164™, an ROR-1 targeted ADC for hematologic and solid malignancies. The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of RB-164™ in patients with ROR-1 positive hematologic and solid cancers in the United States of America.
“The FDA’s clearance of the IND application allows us the opportunity to proceed with the Phase 1 Clinical Trial with a potentially best-in-class ROR-1 targeted ADC for patients with hematologic and solid tumors,” said Marc Lippman, MD, Chairman of Radiance.
“Radiance marks the clearance by the FDA of the IND application for RB-164™ to be a significant milestone for the Company, with its first clinical-stage product candidate to advance into clinic for treating unmet needs in major cancer indications,” said Robert Brooks, JD, Chief Executive Officer.
The Phase 1 clinical trial is expected to be an open-label, dose escalation and expansion study to evaluate the safety and efficacy of RB-164™ in subjects with ROR-1 positive hematologic cancers such as lymphoma, and various solid tumors. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability, and pharmacokinetics as well as anti-tumor activity defined by overall response rate, duration of response, and disease control rate.
About RB-164™
RB-164™ is a next generation ADC that targets ROR-1 expression with an Fc-silenced monoclonal antibody, glutamine side chain-based conjugation to prevent retro-Michael elimination, and site specific conjugation to deliver a homogeneous Drug-to-Antibody distribution for an improved pharmacokinetic and toxicology profile, to the payload MMAE. An IND application for RB-164™ (SYS6005) has been cleared by China’s regulatory agency, the National Medical Products Administration (NMPA). It is currently being investigated by CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093), in a Phase I Clinical Trial in China in hematologic and solid tumors. Radiance has an Exclusive License with CSPC and plans to collaborate to execute clinical development of the drug. Radiance will be responsible for the clinical development of RB-164™ in its licensed territories - the United States, Canada, United Kingdom, western Europe, and Australia.
About Radiance
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including monospecific and bispecific Antibody Drug Conjugates for the treatment of cancer and other unmet medical needs. In addition to RB-164™, Radiance is developing RB-201™, a HER2/TROP2 Bispecific ADC in preclinic 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
