Drug intelligence / Profile preview

PIT565

Development stage
Phase 1
Lead developer
Novartis
Modality
Trispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

PIT565 is an investigational, first-in-class, immunoglobulin G-like trispecific antibody designed for the treatment of B-cell malignancies and systemic lupus erythematosus (SLE). It simultaneously targets CD19 on malignant B cells and engages both CD3 (a T-cell receptor signaling component) and CD2 (a costimulatory receptor) on T cells. This cross-linkage redirects T-cell cytotoxicity toward CD19-positive malignant B cells, potentially overcoming T cell exhaustion through CD2 co-stimulation. Preclinical studies have shown that PIT565 mediates more potent and sustained antitumor responses compared to bispecific antibodies targeting only CD3. The drug is currently being evaluated in phase 1 clinical trials for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), and SLE[1][2][4][5][6].

Other names
anti-CD19/anti-CD3/anti-CD2 trispecific antibody
02

Targets

CD19 (B lymphocyte antigen CD19)CD2 (T-cell Surface Antigen CD2)CD3 (T-cell surface glycoprotein CD3)

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