China-based Blue Shield Biotech’s in-house developed LD013, an autologous chimeric antigen receptor (CAR)-T cell therapy, has obtained clinical trial approval from the National Medical Products Administration (NMPA). The intended indication is recurrent refractory ovarian cancer, a condition that poses significant challenges in treatment and management.
Mesothelin as a Target
Mesothelin (MSLN) is a glycosyl phosphatidylinositol-anchored membrane glycoprotein that is highly expressed in many malignant tumors, including ovarian cancer, but is highly restricted in normal tissues. This unique expression pattern makes MSLN a potential target for developing CAR-T products for ovarian cancer. Blue Shield has developed a next-generation anti-MSLN antibody via its whole human phage antibody library, which has been used to construct and prepare LD013 CAR-T.
Clinical Trial Results
The product has shown a good efficacy and safety profile in an investigator-initiated trial (ITT) carried out in multiple hospitals, including Fudan University Cancer Hospital, the First Affiliated Hospital of Zhejiang University Medical College, Zhongda Hospital Affiliated to Southeast University, Inner Mongolia Autonomous Region Cancer Hospital, and Eastern Theater General Hospital. The study demonstrated significant tumor regression in ovarian cancer patients after treatment. Importantly, no more than grade 2 cytokine storm, neurotoxicity, and CAR-T-related infusion reactions were observed in all subjects, highlighting the therapy’s favorable safety profile.
Future Development
The approval from the NMPA marks a significant milestone for Blue Shield Biotech in advancing its innovative CAR-T therapy. The company aims to further explore the potential of LD013 in treating recurrent refractory ovarian cancer, with the goal of improving patient outcomes and addressing unmet medical needs in this area.-Fineline Info & Tech
