Novartis' Trispecific Antibody PIT565 Granted New Clinical Trial Approval in China for Systemic Lupus Erythematosus
Novartis
Drug Development and Manufacturing
▎WuXi AppTec Content Team Report
On February 7, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that a new drug PIT565, submitted by Novartis, had received a new clinical trial implied permission, intended for development to treatSystemic Lupus Erythematosus (SLE). Public information shows that this is a Novartis research and development product.Anti-CD3/CD19/CD2 Trispecific Antibody, which has already been in ChinaApprovedIND for B-cell malignancies.
Screenshot source:CDE Official Website
In recent years, B-cell depletion therapy has been widely used in the treatment of autoimmune diseases.Clinical studies have reported proof that,CAR-T cells or antibody therapies targeting CD19 can specifically bind to the CD19 antigen on the surface of B cells, eliminating B cells through antibody-dependent or complement-dependent cytotoxicity., which can then effectively reduce the levels of inflammatory mediators in the body, specifically exert immunosuppressive therapeutic effects, and effectively treat autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy.
As aPotential "first-in-class"IgG-like trispecific antibody,PIT565Can target CD19 on malignant B cells, while also binding to CD3 (a TCR signaling component) and CD2 (a co-stimulatory receptor) on T cells.Compared with CD3 bispecific, co-stimulation of CD2 via PIT565 may overcome T-cell exhaustion and increase the depth and duration of patient response.。Studies have shown thatCD2 Signaling Is Associated with a Non-Exhausted T Cell Phenotype。
Currently, PIT565 is in the international multicenter Phase 1 study stage, targeting indications includingRelapsed or refractory B-NHL and R/R CD19-positive B-ALL, as well asSystemic Lupus Erythematosus (SLE).This timePIT565 has been approved for clinical trials in China for the SLE indication, which means that the drug will also enter the clinical development stage in China.
[1] Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Feb 8, 2025, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c
[2]PIT565, a First-in-Class Anti-CD19, Anti-CD3, Anti-CD2 Trispecific Antibody for the Treatment of B Cell Malignancies. Retrieved Nov 15, 2022, from https://ashpublications.org/blood/article/140/Supplement%201/3148/487267/PIT565-a-First-in-Class-Anti-CD19-Anti-CD3-Anti
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