AbelZeta, a Sino-US biotech company with operations in Rockville, Maryland, and Shanghai, has presented data for its armored autologous GPC3-targeted chimeric antigen receptor (CAR) T cell therapy candidate, C-CAR031, at the American Society of Clinical Oncology (ASCO) annual meeting. The CAR-T therapy, co-developed with AstraZeneca (NASDAQ: AZN), is currently in a first-in-human investigator-initiated trial (IIT) in China.
The data presented demonstrated a manageable safety profile and promising anti-tumor activity of C-CAR031 in 24 patients with heavily pretreated advanced hepatocellular carcinoma (HCC), who had received between 1-6 lines of prior therapy. The disease control rate (DCR), indicating tumor shrinkage, was 91.3%. The objective response rate (ORR) was 56.5% across all dose levels (DLs), with a notably higher 75.0% ORR at dosage level 4. Cytokine release syndrome (CRS) was observed in 22 (91.7%) patients, with the majority experiencing grade 1/2 CRS (87.5%) and only one patient (4.2%) experiencing grade 3 CRS.
AbelZeta CEO Tony (Bizuo) Liu commented, “The early data presented today provide compelling proof-of-concept to potentially redefine therapeutic paradigms in HCC and other GPC3-expressing solid tumors.”
C-CAR031 was designed by AstraZeneca and is being manufactured by AbelZeta, with both companies co-developing the therapy under a partnership agreement announced in December 2023.- Flcube.com