NoveCite + LYMPHIR

NoveCite + LYMPHIR is a combination regimen pairing NoveCite, a novel delivery platform or adjuvant designed to enhance immune responses or drug stability, with LYMPHIR (denileukin diftitox-cxdl), a recombinant fusion protein immunotherapy approved by the FDA in August 2024 for relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments, selectively binding high-affinity IL-2 receptors on malignant T-cells and immunosuppressive regulatory T-cells (Tregs), leading to toxin internalization, inhibition of protein synthesis, and cell death; this dual action provides direct tumoricidal effects and transient Treg depletion to unleash antitumor immunity. Developed and commercialized by Citius Pharmaceuticals and Citius Oncology, it demonstrated a 36.2% objective response rate in the pivotal Phase 3 Study 302, rapid pruritus relief (median 1.4 months to response), and no cumulative toxicity, addressing an unmet need as the first new FDA-approved CTCL systemic therapy in over seven years.

Other names

denileukin diftitox-cxdl