The world’s first CAR-T for the treatment of inflammatory diseases

National Medical Products of China (NMPA) approved a new investigational application from IASO Bio for the new expanded indication of neuromyelitis visual spectrum disorder (NMOSD).

Neuromyelitis optica disorders, formerly known as Dewick’s disease or neuromyelitis optica, are inflammatory diseases of the central nervous system characterized by severe immune-mediated demyelination and axonal damage, mainly targeting the optic nerves and spinal cord.

An announcement that Drug Evaluation Center today (August 19) was given the go-ahead for the fully human B-cell maturation antigen (BCMA) autologous T-cell (CAR-T) injection, equicabtogenic autoleucel.

This is the world’s first IND approval for CAR-T in the treatment of NMOSD.

Immunosuppressant

The new IND application is based on clinical data from an investigator-initiated clinical trial of equecabtagene autoleucel. Subjects in the study were patients with NMOSD with poor symptom control who had received at least one year of treatment with at least one immunosuppressant.

The primary objective of the study was to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) profiles in patients with NMOSD treated with equicabtogen autoleucel.

Wen Maxwell Wang, Chief Executive Officer and Chief Medical Officer Biography of IASOsaid: “As one of the first companies to conduct CAR-T studies for the treatment of autoimmune diseases worldwide, our BCMA CAR T-cell therapy represents a significant milestone for data from investigator-initiated (IIT) relapsed and refractory NMOSDan autoimmune disease with serious complications, blindness and paralysis.’

Autoimmune systems

The existing treatment of NMOSD can only reduce the number of relapses over a certain period and has little effect on the functional recovery of the sensory, nervous and motor systems. BCMA CAR T-cell therapy can reduce disability score and improve sensory, nervous and motor function, providing important proof-of-concept for CAR-T therapy for the treatment of autoimmune diseases caused by autoantibodies produced by plasma cells.

The IND approval demonstrates IASO Bio’s continued momentum to advance the expansion of CAR-T therapy and launch products beyond the treatment of malignancies to autoimmune diseases. IASO Bio will initiate and complete a clinical trial according to the submitted protocol to prepare for the New Drug Application (NDA) and bring hope to patients with NMOSD.