United States EST, Aug. 5, 2024 /PRNewswire
Salubris Biotherapeutics, Inc. (Salubris Bio), a partner of MabPlex, announced that its innovative, broad-spectrum oncology biologic JK06, has been approved for a Phase-I clinical trial following submission of their Clinical Trial Application (CTA). As the CMC partner of Salubris Bio MabPlex would like to extend its congratulations to Salubris Bio and all best wishes for their future success! This project is the 21st ADC program executed by the MabPlex team from preclinical pharmacy research to obtaining clinical trial approval, and the 42nd ADC IND overall.
JK06, a 5T4-Targeted ADC, is overexpressed in a wide range of tumor types. Following technology transfer, MabPlex worked closely with the Salubris Bio team of subject matter experts to efficiently complete supporting efforts such as process confirmation, analytical method optimization and qualification, and cGMP production.
“Thanks to the efforts of the MabPlex team, the JK06 product was successfully submitted for CTA,” provided Dr. Sam Murphy (CEO of Salubris Bio). “When interacting with regulatory personnel, the quality of the CMC work was noted, and no supplementary revisions were required. Thank you again for your support and dedication to this project!”
From Dr. Xinfang Li (CEO of MabPlex): “We would like to congratulate Salubris on the approval of the JK06 clinical program in Europe. MabPlex is honored to be a part of this CTA application, which demonstrates once more the technical strength and service level of the MabPlex team in their efforts to support the ADC market. We are expanding rapidly and look forward to providing future partners with efficient, comprehensive, industry-leading services.”
MabPlex’s Campus in Yantai, China
Salubris Bio is a clinical-stage biotechnology company focused on the discovery and development of complex biologics for cardiovascular, oncology, and neurodegenerative diseases. Salubris is currently advancing multiple first-in-class therapies through clinical development programs and has established a rich pipeline of innovative drugs.
MabPlex is a CDMO company focused on providing professional, customized, and integrated CDMO services for antibodies, antibody drug conjugates, recombinant proteins, and other biologic drugs. MabPlex is one of the few organizations in the world that can provide comprehensive services across the clinical production of antibody drug conjugates. At present, over one hundred submissions across a wide variety of large-molecule biologics have been successfully completed. With 10+ years of focus on antibody-drug conjugates, a mature technology platform, and an average of 20+ years across CMC team leadership, MabPlex has collaborated with biopharmaceutical companies in China, the United States, Europe, Korea, India, Australia, et al.
