Radiance Biopharma Signs Exclusive License For ‘First In Class’ c-Met/EGFR Targeted Nano Antibody ADC
BOSTON, Sept. 03, 2025 (GLOBE NEWSWIRE) -- Radiance Biopharma, Inc., ("Radiance" or "Company"), a clinical-stage biotechnology company, announced that it has signed an Exclusive License Agreement with Novatim Immune Therapeutics (Zhejiang) CO., LTD. , (“Novatim”) for the development and commercialization of RB-601™ (KY-0301), a novel Antibody Drug Conjugate (ADC) comprising a Bispecific Nanobody targeting c-MET and EGFR.
RB-601™ is a ‘First In Class’ Bispecific Nano Antibody ADC that targets mesenchymal-epithelial transition tyrosine kinase receptor (c-MET) and epidermal growth factor receptor (EGFR). Both c-MET and EGFR antibody targets are clinically, and market validated in various solid tumors. RB-601™ utilizes site specific conjugation to deliver a homogeneous Drug-to-Antibody Ration (DAR) of four (4), and an innovative, ‘tuned down’ EGFR affinity to enhance the safety profile. When internalized, RB-601™ releases a monomethyl auristatin E (MMAE) payload, inhibiting cell division. Preclinical mice and Non-Human Primate data have demonstrated promising efficacy and safety in tumors expressing MET and EGFR including non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer kidney cancer, and other malignancies.
An Investigational New Drug (IND) application for RB-601™ has been cleared by China's regulatory agency, the National Medical Products Administration (NMPA). RB-601™ is currently being investigated by NOVATIM in a Phase 1 clinical trial in advanced solid tumors in China. The U.S. Food and Drug Administration (FDA) has approved an IND application.
‘We are excited to add RB-601™, a promising First in Class and potentially Best in Class clinical-stage c-MET/EGFR Targeted Bispecific Nanobody Drug Conjugate to our pipeline’ said Dr. Marc Lippman, MD, Chairman of the Board of Radiance. ‘Expanding our pipeline with RB-601™, furthers our mission to develop novel medicines for solid tumors with high unmet needs worldwide and accelerates our ADC portfolio by adding a program in clinical trials’.
‘Radiance is dedicated to advancing next-generation therapies for advanced cancers. RB-601™ enhances Radiance’s clinical stage pipeline and position in precision oncology. We look forward to harnessing our expertise and specialized knowledge in solid cancers to deliver meaningful outcomes to patients’ said Robert Brooks, JD, Chief Executive Officer of Radiance.
‘This collaboration with Radiance marks a significant milestone for NOVATIM. RB-601™ (KY-0301) has demonstrated strong potential across multiple tumor types where EGFR and c-MET are key drivers. We believe it could provide a differentiated treatment option for patients with NSCLC, colorectal cancer, and head and neck cancer, all of which represent areas of high unmet medical need worldwide. Partnering with Radiance allows us to accelerate global development and bring this innovative therapy to patients faster.’ said Dr. Guoxiang Wu, MD, Founder and Chairman of NOVATIM.
Under the terms of the Exclusive License, Radiance will pay NOVATIM an upfront payment of USD$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. The License agreement grants Radiance a worldwide (excluding China's mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize RB-601™. Radiance will be responsible for the clinical development of RB-601™ in the US and other licensed territories.
About Radiance
Radiance is developing a pipeline of monospecific and bispecific ADCs to treat 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, that achieved market approval of three (3) ADCs (acquired by Pfizer). Radiance's current oncology pipeline includes RB-164™, a ROR-1 targeted ADC for liquid and solid tumors, in clinical trials, and preclinical studies of RB-201™, a bispecific HER2xTROP2 ADC for solid tumors. For more information on Radiance visit www.radiancebiopharma.com.
About NOVATIM
Established in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. operates with Tinova (Shanghai) as its wholly-owned subsidiary, focusing on pioneering advancements in cancer treatment, NOVATIM is dedicated to the research and clinical application of innovative cancer immunotherapy. Based on unmet clinical needs and differentiated innovation, NOVATIM has built three core R&D platforms: bispecific antibody platform, nanobody-based ADC platform, enhanced dual-target CAR-T cell platform. 10 FIC/BIC pipelines were developed based on NOVATIM’s technological breakthroughs. For more information on Novatim visit http://novatim-zj.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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