NOVARTIS AG's new triple-antibody drug has been approved for clinical use in China, targeting systemic lupus erythematosus
Novartis's Class 1 new drug PIT565 has obtained a new clinical trial implicit approval in China, aimed at treating systemic lupus erythematosus (SLE). The drug is a tri-specific antibody targeting CD3/CD19/CD2 and is currently in the international multi-center Phase 1 research stage. This approval marks the entry of PIT565 into the clinical development phase in China, potentially overcoming T cell exhaustion through co-stimulation of CD2, enhancing the depth and duration of patient responses
According to the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, Novartis (NVS.US) has received a new implied license for clinical trials for its Class 1 new drug PIT565, which is intended for the treatment of systemic lupus erythematosus (SLE). Public information shows that this is a trispecific antibody targeting CD3/CD19/CD2 that Novartis is developing, which has previously been approved in China for an IND targeting B-cell malignancies.
Currently, PIT565 is in the international multicenter Phase 1 research stage, 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 PIT565 for the SLE indication in China means that the drug will also enter the clinical development stage in China.
Public information indicates that PIT565 can target CD19 on malignant B cells while also binding to CD3 (TCR signaling component) and CD2 (a co-stimulatory receptor) on T cells. Compared to CD3 bispecifics, co-stimulating CD2 through PIT565 may overcome T cell exhaustion and increase the depth and duration of patient responses. Studies have shown that CD2 signaling is associated with a non-exhausted T cell phenotype
