SEOUL, South Korea, Oct. 13, 2023 /PRNewswire/ — Recently, ABL Bio, a partner of GenScript ProBio, announced the Ministry of Food and Drug Safety (MFDS) cleared of its clinical trial application for innovative bispecific antibody program (B7H4x4-1BB) in solid tumor. GenScript ProBio warmly extends congratulations on this major milestone achievement. In this ABL103 program, GenScript ProBio provided the service of process development & optimization, clinical material manufacturing, and CTD documentation preparation for MFDS IND filing.
ABL103 is a novel T-cell engaging bispecific antibody and demonstrates efficacious anti-tumor activity via B7-H4 mediated 4-1BB activation in tumor microenvironments (TME), only activating 4-1BB signaling pathways when in the presence of B7-H4 expressing cells. ABL103 strongly inhibits tumor growth and induces immunological memory to create prolonged anti-tumor protection. Since B7-H4 has similar mechanisms with PD-(L)1 based immuno-therapy but shows negative correlation in expression, it is regarded as attractive target to overcome the limitation of existing PD-(L)1 based immuno-therapy represented with Keytruda whose effective patients are limited within 20% among total patients. Also, differentiated epitope binding spot adds ABL103’s competitiveness with strong efficacy by avoiding competition with 4-1BB(L) binding.
In 2024, GenScript ProBio will launch its commercial manufacturing facility with 8*2000L singe use bioreactors, offering a one-stop solution from target discovery to BLA submission and commercial manufacturing. As of September 2023, GenScript ProBio has helped global clients in obtaining 30 IND clearance in the field of antibody and proteins drugs and 40% of them are for bispecific antibodies and recombinant proteins, with the fastest project receiving Emergency Use Authorization (EUA). Furthermore, GenScript ProBio serves as the antibody raw material supplier for two medical device products.
Mr. Sang Hoon Lee, CEO of ABL Bio stated, “With ABL103, we are exemplifying our commitment to target selection that aligns with prevailing global trends. By employing the ‘Grabody-T’ platform technology, which is founded on 4-1BB-based bispecific antibodies, we are bolstering our competitive edge in various 4-1BB based pipelines including ABL103 targeting B7-H4 expressing tumor. The project is advancing into the clinical trial phase, and we express our deep gratitude to GenScript ProBio for their swift and top-notch support, which has played a pivotal role in expediting our progression to the clinical trial phase due to their extensive expertise and capabilities.”
Dr. Patrick Liu, Chairman and Acting CEO of GenScript ProBio said, “We congratulate ABL Bio on MFDS clearance of its IND application, and we are honored to be part of this innovative bispecific antibody project. Together, we aim to leverage our collective expertise and state-of-the-art technology to bring novel therapies to patients worldwide, addressing unmet medical needs and contributing to the advancement of healthcare as a whole. “
ABL Bio is a research-led biotechnology company, a pioneer in bispecific antibodies. With bispecific antibody platform technology ‘Grabody-T’ and ‘Grabody-B’, ABL Bio has been developing innovative drugs for immuno-oncology and neurodegenerative diseases. ABL Bio is also focusing on next-generation ADC development by utilizing competitive bispecific antibodies. Delivering new approaches to address the highest unmet needs, ABL Bio is committed for ‘a better life’ for people all over the world.
GenScript ProBio – A Global CDMO
GenScript ProBio, a subsidiary of GenScript Biotech Corporation, offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in CGT, vaccine, antibody and recombinant protein drug, aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 60 IND approvals since October 2017.