Biosino Bio-Pharma's PA3-17 Injection, a First-in-Class CD7-Directed CAR-T Therapy, Receives IND Approval for Relapsed/Refractory CD7-Positive Hematologic Malignancies

On August 9, ANKEBIO announced that its investee company, BoShengJi Medicine Science and Technology (Suzhou) Co., Ltd., received the "Notice of Approval for Clinical Trials of Drugs" approved and issued by the National Medical Products Administration (NMPA), authorizing the conduct of clinical trials for the treatment of adult relapsed/refractory CD7-positive hematological and lymphoid malignancies.

Approved for clinical trials is the world's first nanobody-based CD7-CAR-T cell injection independently developed by Bosengji (development code: PA3-17 Injection). Its indication is for adult patients with relapsed or refractory CD7-positive hematological and lymphoid malignancies. The initial clinical trial application for this drug was accepted on May 17, 2021.

CD7-positive malignant tumors predominantly encompass highly aggressive lymphomas or leukemias, characterized by rapid disease progression and poor prognosis, with the majority of cases relapsing within a short period following chemotherapy-induced remission. These conditions primarily include T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), early T-cell precursor acute lymphoblastic leukemia (ETP-ALL), extranodal NK/T-cell lymphoma, as well as various rare and uncommon diseases. For the treatment of relapsed/refractory T-ALL/LBL, nelarabine is the only therapy approved internationally by the US FDA, and it is not currently marketed in China. However, the latest Phase IV clinical trial data presented at the European Hematology Association (EHA) conference in June 2019 revealed that patients receiving nelarabine monotherapy achieved a 1-year overall survival (OS) rate of 38%, a 5-year OS rate of 18%, and a median survival time of merely 8 months. Consequently, indications such as relapsed/refractory T-ALL/LBL represent a critical unmet clinical need. The autologous CD7-CAR-T cells developed by BoShengJi Medicine Science and Technology (Suzhou) Co., Ltd. circumvent the risks associated with gene editing. Coupled with superior in vivo expansion and persistence, they demonstrate significant therapeutic efficacy and a favorable safety profile.