Novartis AG sponsored ADR (NVS.US) obtains clinical approval again for three new anti-drug therapies targeting systemic lupus erythematosus in China.

The latest announcement on the official website of China National Medical Products Administration's Center for Drug Evaluation (CDE) reveals that Novartis AG Sponsored ADR (NVS.US) has obtained a new clinical trial implicit license for a type 1 new drug PIT565, intended for the treatment of systemic lupus erythematosus (SLE). Public information shows that this is a triple-specific antibody targeting CD3/CD19/CD2 developed by Novartis AG Sponsored ADR, which has previously obtained regulatory approval in China for the treatment of B-cell malignancies. Currently, PIT565 is in Phase 1 of an international multi-center study, targeting indications including relapsed or refractory B-NHL and R/R CD19-positive B-ALL, as well as systemic lupus erythematosus (SLE). The approval of the clinical trial for SLE in China means that this drug will also enter the clinical development stage in China. Public information reveals that PIT565 can target CD19 on malignant B cells, while also binding to CD3 on T cells (a component of TCR signaling) and CD2 (a co-stimulatory receptor). Compared to CD3 bispecific antibodies, co-stimulation of CD2 through PIT565 may overcome T cell exhaustion and enhance the depth and duration of patient responses. Research suggests that CD2 signaling is associated with a non-exhausted T cell phenotype.