Radiance Biopharma has secured exclusive global licensing rights to RB-601™ (KY-0301), a novel first-in-class bispecific nanobody antibody-drug conjugate (ADC) that simultaneously targets c-MET and EGFR receptors. The clinical-stage biotechnology company announced the agreement with Novatim Immune Therapeutics on September 3, 2025, marking a significant expansion of its oncology pipeline.
Innovative Dual-Target Approach
RB-601™ represents a breakthrough in ADC design, targeting both mesenchymal-epithelial transition tyrosine kinase receptor (c-MET) and epidermal growth factor receptor (EGFR). Both targets are clinically and market validated across various solid tumors. The bispecific nanobody utilizes site-specific conjugation to achieve a homogeneous drug-to-antibody ratio (DAR) of four, coupled with an innovative "tuned down" EGFR affinity designed to enhance the safety profile.
When internalized by cancer cells, RB-601™ releases a monomethyl auristatin E (MMAE) payload that inhibits cell division. Preclinical studies in mice and non-human primates have demonstrated promising efficacy and safety across tumors expressing MET and EGFR, including non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, kidney cancer, and other malignancies.
Clinical Development Status
The ADC has achieved significant regulatory milestones, with an Investigational New Drug (IND) application cleared by China's National Medical Products Administration (NMPA) and approved by the U.S. Food and Drug Administration (FDA). RB-601™ is currently being investigated by Novatim in a Phase 1 clinical trial for advanced solid tumors in China.
"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, 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."
Financial Terms and Global Rights
Under the exclusive license agreement, Radiance will pay Novatim an upfront payment of $15 million, with potential development and regulatory milestone payments up to $150 million and commercial milestone payments exceeding $1 billion. The company will also pay tiered royalties based on annual net sales. The agreement grants Radiance worldwide exclusive rights to develop and commercialize RB-601™, excluding China's mainland, Hong Kong, Macao, and Taiwan.
Addressing Unmet Medical Needs
Dr. Guoxiang Wu, Founder and Chairman of Novatim, emphasized the therapeutic potential across multiple cancer types: "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."
Robert Brooks, Chief Executive Officer of Radiance, highlighted the strategic importance of the acquisition: "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."
Company Portfolios
Radiance is developing a comprehensive pipeline of monospecific and bispecific ADCs for cancer treatment. The company's current oncology portfolio includes RB-164™, a ROR-1 targeted ADC for liquid and solid tumors currently in clinical trials, and RB-201™, a bispecific HER2xTROP2 ADC for solid tumors in preclinical studies. The company benefits from the expertise of Dr. Marc Lippman, a renowned oncologist and former founding board member of Seagen, which achieved market approval of three ADCs before being acquired by Pfizer.
Novatim, established in 2018, has built three core R&D platforms: bispecific antibody platform, nanobody-based ADC platform, and enhanced dual-target CAR-T cell platform. The company has developed 10 first-in-class/best-in-class pipelines based on its technological breakthroughs in cancer immunotherapy.
