BOSTON, MA, USA I February 19, 2025 I Radiance Biopharma, Inc., (“Radiance” or the “Company”), a biotechnology company, today announced that it has entered into an exclusive License agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for 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.
“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,” said Dr. Marc Lippman, MD, Chairman of the Board of Radiance.
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 and over $1 Billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales.
“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,” said Robert Brooks, JD, Chief Executive Officer of Radiance. “We look forward to expand our pipeline with a novel clinical stage medicine for patients with cancer and high unmet needs.”
“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,” said Zhang Cuilong, Chief Executive Officer of CSPC.
About Radiance
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including monospecific and Bispecific Antibody Drug Conjugates (ADCs) for the treatment of cancer and other unmet medical needs. The Chairman of the Board and Co-Founder of Radiance, Marc Lippman, MD, is a renowned oncologist and former founding board member of Seagen, a leader in the field of ADCs which was recently acquired by Pfizer. Martin Olivo, MD, Chief Medical Officer (CMO) of the Company is the former CMO at Systimmune, Inc., and prior VP of Clinical Development at Immunomedics which was acquired by Gilead. Radiance’s current oncology pipeline includes RB-201, a bispecific HER2xTROP2 ADC for solid tumors. For more information on Radiance visit www.radiancebiopharma.com.
About CSPC Pharmaceutical Group Limited
CSPC is a leading pharmaceutical conglomerate in China with strong capabilities in research and development, manufacturing, and marketing of innovative drugs. The Company was listed on the Hong Kong Stock Exchange (stock code: HK1093) in 1994 and became a constituent stock of the Hang Sang Index in 2018. Currently, it is also a constituent stock of Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland Healthcare Index, Hang Seng Stock Connect Index, Hang Seng (Hong Kong-listed) 100 Index and Hang Seng China Enterprise Index. CSPC has more than 24,000 employees. CSPC has a national top research and development team with research and development bases in Shijiazhuang, Shanghai, Beijing, and the United States, focusing on the discovery, research and development of small molecule targeted drugs, nanodrugs, monoclonal antibody drugs, bispecific antibody drugs, antibody-drug conjugates, mRNA vaccines, small nucleic acid drugs and biological drugs in the immune field.
SOURCE: Radiance
Post Views: 248
BOSTON, MA, USA I February 19, 2025 I Radiance Biopharma, Inc., (“Radiance” or the “Company”), a biotechnology company, today announced that it has entered into an exclusive License agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for 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.
“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,” said Dr. Marc Lippman, MD, Chairman of the Board of Radiance.
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 and over $1 Billion in potential commercial milestone payments, as well as potential tiered royalties based on annual net sales.
“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,” said Robert Brooks, JD, Chief Executive Officer of Radiance. “We look forward to expand our pipeline with a novel clinical stage medicine for patients with cancer and high unmet needs.”
“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,” said Zhang Cuilong, Chief Executive Officer of CSPC.
About Radiance
Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including monospecific and Bispecific Antibody Drug Conjugates (ADCs) for the treatment of cancer and other unmet medical needs. The Chairman of the Board and Co-Founder of Radiance, Marc Lippman, MD, is a renowned oncologist and former founding board member of Seagen, a leader in the field of ADCs which was recently acquired by Pfizer. Martin Olivo, MD, Chief Medical Officer (CMO) of the Company is the former CMO at Systimmune, Inc., and prior VP of Clinical Development at Immunomedics which was acquired by Gilead. Radiance’s current oncology pipeline includes RB-201, a bispecific HER2xTROP2 ADC for solid tumors. For more information on Radiance visit www.radiancebiopharma.com.
About CSPC Pharmaceutical Group Limited
CSPC is a leading pharmaceutical conglomerate in China with strong capabilities in research and development, manufacturing, and marketing of innovative drugs. The Company was listed on the Hong Kong Stock Exchange (stock code: HK1093) in 1994 and became a constituent stock of the Hang Sang Index in 2018. Currently, it is also a constituent stock of Hang Seng Composite Index, Hang Seng Healthcare Index, Hang Seng Mainland Healthcare Index, Hang Seng Stock Connect Index, Hang Seng (Hong Kong-listed) 100 Index and Hang Seng China Enterprise Index. CSPC has more than 24,000 employees. CSPC has a national top research and development team with research and development bases in Shijiazhuang, Shanghai, Beijing, and the United States, focusing on the discovery, research and development of small molecule targeted drugs, nanodrugs, monoclonal antibody drugs, bispecific antibody drugs, antibody-drug conjugates, mRNA vaccines, small nucleic acid drugs and biological drugs in the immune field.
SOURCE: Radiance
Post Views: 248
