Drug intelligence / Profile preview

Ad.p53-DC + nivolumab + ipilimumab

Development stage
Unknown
Lead developer
Moffitt Cancer Center
Modality
Dendritic Cell Vaccines → Immune Effector Cells → Other Cell Types → Cell Therapies, Gene Therapies, Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous, Intradermal
01

Overview

Ad.p53-DC + nivolumab + ipilimumab is an investigational combination immunotherapy regimen being evaluated for the treatment of relapsed or recurrent small cell lung cancer (SCLC). The regimen consists of **Ad.p53-DC** (also known as INGN-225), an autologous dendritic cell vaccine transduced with the full-length wild-type p53 gene via an adenoviral vector, alongside the immune checkpoint inhibitors **nivolumab** (an anti-PD-1 monoclonal antibody) and **ipilimumab** (an anti-CTLA-4 monoclonal antibody). The therapeutic rationale is based on the high frequency of p53 mutations in SCLC, which leads to the overexpression of p53 protein in tumor cells. The vaccine is designed to prime the immune system to recognize these p53-expressing cells, while the checkpoint inhibitors work to sustain the immune response by blocking inhibitory signals that tumors use to evade detection. This combination is primarily being investigated in Phase 2 clinical trials led by the H. Lee Moffitt Cancer Center and Research Institute.

Brand names
OpdivoYervoy
Other names
p53 vaccine + nivolumab + ipilimumabAd-p53 transduced dendritic cell vaccine + nivolumab + ipilimumab
02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)TP53 (Cellular Tumor Antigen p53 R175H)PDCD1 (Programmed cell death protein 1 receptor)

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