News
Article
Author(s):
Radiance Biopharma partners with Novatim to advance RB-601, a promising bispecific nanobody ADC targeting key cancer drivers for solid tumors.
Radiance will develop and commercialize the first in class Bispecific Nano Antibody ADC worldwide.
Stock.adobe.com
Radiance Biopharma announced it has entered an exclusive license agreement with Novatim Immune Therapeutics to commercialize and develop RB-601, an Antibody Drug Conjugate (ADC) comprised of bispecific nanobody targeting c-MET and EGFR.
Dr. Guoxiang Wu, MD, founder and chairman of Novatim, touched on the importance of the collaboration, saying, “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.”1
RB-601 is a first in class bispecific nanobody ADC, targeting mesenchymal-epithelial transition tyrosine kinase receptors(c-MET), and epidermal growth factor receptor (EGFR).1 Additionally, both c-MET and EGFR antibody targets are validated for both the market and clinically in various solid tumors. RB-601employs the use of site-specific conjugation, delivering a homogeneous Drug-to-Antibody Ration (DAR) of four, along with a dampened EGFR affinity enhancing its safety profile.
When internalized, RB-601releases a monomethyl auristatin E (MMAE) payload, inhibiting cell division.1 Data collected from preclinical mice, along with non-human primates, demonstrating promising efficiency and safety in tumors expressing both c-MET and EGFR. This includes non-small cell lung cancer, as well as other malignancies.
RB-601’s Investigational New Drug Application was recently cleared by China’s regulatory agency the National Medical Products Administration (NMPA). This positioned RB-601 to be investigated by Novatim with a Phase I clinical trial advancing solid tumors in China, along with U.S. FDA approving the 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.”1
Robert Brooks, JD, chief executive officer of Radiance, commented on the licensing agreement, saying, “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.”1
Radiance will pay Novatim an upfront payment upwards of $15 million, and up to $150 million in potential developmental and regulatory milestone payments with over $1 billion in potential commercial milestone payments from tiered royalties based on annual net sales. The agreement grants Radiance a worldwide (excluding mainland China, Hong Kong, Macao, and Taiwan) exclusive license to develop and commercial RB-60. Radiance is also responsible for the clinical development of RB-601 in the U.S. and other licensed territories.
Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.
