Anke Biotech investee’s CAR-T therapy approved for pivotal phase II trial

Anhui Anke Biotechnology Group announced its investee, Anke Cell Biotechnology, received approval from China's National Medical Products Administration for its PA3-17 injection to enter pivotal phase II clinical trials. The PA3-17 injection is a self-developed, CD7-targeted autologous CAR-T cell therapy for adult relapsed/refractory CD7-positive hematologic malignancies.

The therapy completed phase I trials for adult relapsed/refractory T-lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL), showing an objective response rate (ORR) of 84.6% and manageable safety. Following this, PA3-17 was granted breakthrough therapy designation.

Anke Cell Biotech will now proceed with pivotal phase II clinical trials for R/R T-ALL/LBL. However, the announcement cautions investors about the inherent uncertainties in drug development, including trial duration, results, and future market competition.