Radiance Biopharma Enters Exclusive License for ROR-1 Targeted Antibody Drug Conjugate

Radiance Biopharma, Inc. (Radiance) has entered into an exclusive license agreement with CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (CSPC), for the development and commercialization of RB-164 (SYS6005), a novel clinical-stage antibody drug conjugate (ADC) targeting ROR-1. The agreement covers exclusive commercialization rights to RB-164 in the United States of America (USA), Canada, the European Union, the United Kingdom, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, and Australia. CSPC will retain all rights to SYS6005 in the remaining global markets.

ROR-1 is highly expressed in embryonic tissue, and a variety of hematological malignancies and solid tumors. ROR-1 expression is low in healthy adult cells but is closely related to disease progression and treatment response in cancer. This makes ROR-1 an attractive therapeutic target for anti-cancer drug development. RB-164 employs a novel Fc-silenced monoclonal antibody targeting ROR-1, site-specific conjugation to deliver a homogeneous Drug-to-Antibody distribution and prevent retro-Michael elimination (high stability), which provides an improved pharmacokinetic and toxicology profile.

An Investigational New Drug (IND) application for RB-164 has been cleared by China's regulatory agency, the National Medical Products Administration (NMPA). RB-164 is currently being investigated by CSPC in a Phase 1 dose escalation clinical trial in advanced liquid and solid tumors in China. Radiance and CSPC will work collaboratively to file an IND application with the USA Food & Drug Administration (FDA) to execute the clinical development of RB-164. Radiance will be responsible for the clinical development of RB-164 in the US and other licensed territories.

Under the terms of the exclusive license, Radiance will pay CSPC an upfront payment of $15 million, and up to $150 million in potential development and regulatory milestone payments, as well as over $1 billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales. Radiance's Chairman of the Board and Co-Founder, Dr. Marc Lippman, MD, stated, "We are excited to add RB-164, a promising clinical-stage Antibody Drug Conjugate targeting ROR-1, to our pipeline. This provides multiple shots on goal for potential therapeutic indications and strengthens Radiance’s development into a significant biopharma company."

Radiance's Chief Executive Officer, Robert Brooks, JD, added, "We believe that RB-164 has the potential to be a best-in-class ADC against the clinically validated target of ROR-1 for the treatment of liquid and solid malignancies. We look forward to expanding our pipeline with a novel clinical stage medicine for patients with cancer and high unmet needs." Zhang Cuilong, Chief Executive Officer of CSPC, commented, "This collaboration with Radiance exemplifies our commitment to bringing our innovative treatments to patients worldwide. We look forward to working together in advancing this ADC as a promising treatment option to those battling cancer."

Radiance's licensing agreement with CSPC for RB-164 has significant implications for the competitive landscape in the ROR1 ADC market. Merck & Co. is currently leading the ROR1 ADC race with its own candidate, which has shown a 100% complete response rate in a trial of diffuse large B-cell lymphoma (DLBCL) and has moved into phase 3. Radiance's entry into the market with RB-164 will directly compete with Merck's candidate, potentially challenging its dominance in this indication. Other companies, such as CStone Pharmaceuticals, Immunome, and Ipsen, are also developing ROR1-targeted ADCs, and Radiance's licensing agreement with CSPC may put pressure on these companies to accelerate their own development efforts or consider strategic partnerships to stay competitive.



In conclusion, Radiance Biopharma's exclusive license agreement with CSPC for RB-164, a ROR1-targeted ADC, has the potential to significantly impact the competitive landscape in this therapeutic area. The agreement provides Radiance with a promising clinical-stage medicine for patients with cancer and high unmet needs, while also putting pressure on other companies developing similar therapies to stay competitive. As the clinical development of RB-164 progresses, investors and analysts will closely monitor the drug's performance and potential market impact.