Immunotech Biopharm’s CAR-T-19-D2 IND Filing Accepted by NMPA

China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced that an Investigational New Drug (IND) filing for its CAR-T-19-D2 (CAR-T-19-DNR or RC19D2) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication is recurrent and refractory diffuse large B-cell lymphoma (DLBCL).

Mechanism of Action and CAR Technology
CAR-T-19-D2 targets CD19. The CAR technology links anti-CD19 single-chain antibody, protein transmembrane domain, costimulatory molecular domain, and other components to avoid issues such as the inability of autoimmune cells to recognize human CD19 protein, the inhibition of tumor cells on immune cells, and insufficient signals of the second messenger pathway. This allows modified T cells to directly recognize CD19 molecules and kill cells carrying targets, achieving the goal of tumor treatment.

Company Background and Development Pipeline
Founded in 2006, Immunotech Bio is also developing Expanded Activated Lymphocytes (EALs) products, in addition to CAR-T and TCR-T cells. The acceptance of the IND filing for CAR-T-19-D2 by the NMPA marks a significant step forward in the company’s efforts to address significant unmet medical needs in the treatment of DLBCL.-Fineline Info & Tech