Treatment of Non-Small Cell Lung Cancer patients with an innovative cell-based cancer vaccine, PDC*lung01

The clinical activity of new immunotherapies in cancer, such as anti-PD-1/PD-L1, has revealed the importance of the patient’s immune system in controlling tumor development. As in infectious diseases, dendritic cells (DCs) are critical for inducing immune responses in cancer. Unfortunately, autologous DC-based vaccines have not yet demonstrated their clinical benefit.
A novel approach using an allogeneic plasmacytoid dendritic cell (PDC) line as an antigen presentation platform showed great potency when used to prime and expand antitumor-specific CD8+ T cells in vitro and in vivo in a humanized mouse model. This PDC platform, named PDC*vac, was first evaluated in the treatment of melanoma with encouraging results, and is currently being evaluated in the treatment of lung cancer in combination with anti-PD-1 immunotherapy.
The candidate vaccine named “PDC*lung01” consists of the PDC*line cells expanded in large volume in bioreactor and loaded with peptides from six tumor antigens expressed in lung cancer: MAGE-A3, MAGE-A4, Multi-MAGE, Survivin, NY-ESO-I, and MUC1.
The final drug product (DP) is stored frozen for a long time in a ready-to-use formulation. Given its stability during storage, the DP is very attractive for bench-to-bedside transfer, because it has only to be thawed at room temperature and drawn through a syringe before being injected into patients.
In this ongoing, open-label, dose-escalation phase I/II study (NCT03970746), we are assessing the safety, tolerability, immunogenicity, and preliminary clinical activity of PDC*lung alone, or in combination with anti-PD-1 treatment (pembrolizumab). The first evaluation of clinical activity is expected in early 2023.