Heyjulin (Inaticabtagene Autoleucel), a Proprietary CD19 CAR-T Therapy by Heyuan Bio, Receives FDA IND Clearance for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

On March 9, 2023, Juventas announced that the IND application for Inaticabtagene Autoleucel Injection (tentative name) (CNCT19 Cell Injection, Inaticabtagene Autoleucel) had been approved by the U.S. FDA for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). Inaticabtagene Autoleucel Injection is the first CD19 CAR-T drug with full independent intellectual property rights in China to submit a New Drug Application (NDA) and is expected to be approved for marketing within the year.

Hercaron Injection, with its globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes, has achieved a 100% success rate in the production of cellular drugs in clinical studies for adult r/r B-ALL. Previously, Hercaron Injection received "Breakthrough Therapy Designation (BTD)" from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China and "Orphan Drug Designation (ODD)" from the U.S. FDA.

In December 2022, the New Drug Application (NDA) for HerClyna Injection for the treatment of adult r/r B-ALL was officially accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration and included in the "Priority Review." HerClyna Injection demonstrated a durable high remission rate and significantly reduced severity of CAR-T therapy-associated toxicity in a China-based multi-center pivotal clinical study for adult r/r B-ALL, marking a major breakthrough in the field of adult r/r B-ALL in China in nearly 30 years.

At the 64th American Society of Hematology (ASH) Annual Meeting held in December 2022, Juventas presented this pivotal clinical research data to the global audience in the form of an oral presentation (Oral Presentation, #0660).

1. Durable High Remission Rate: The overall response rate (ORR) reached 82.1%, and the median duration of response (DOR) had not been reached at a median follow-up of 9.3 months. Among patients still in remission at 3 months, it is estimated that 80% will remain in remission at 1 year. Regardless of whether subsequent hematopoietic stem cell transplantation was received, sustained remission and long-term survival benefits were observed.

2. Significantly Reduced Severity of CAR-T Treatment-Related Toxicities: Incidence of Grade 3 or Higher Cytokine Release Syndrome (CRS) was 10.3%; Incidence of Grade 3 or Higher Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) was 7.7%, with no unexpected adverse events related to CD19-targeted CAR-T treatment observed.

3. A durable high remission rate and safety profile significantly superior to existing treatments represents a major breakthrough in the treatment of adult r/r B-ALL.

Editor: Liu Li

Disclaimer: This article is a reprint from PharmNet. The images and text are owned by the original author, and the purpose of the reprint is to convey more information, which does not represent the views of this platform. If there are any issues regarding content, copyright, or other problems, please leave a message on this platform, and we will handle it promptly.