Expanded
Access

DOC1021 is a multi-step process that harnesses the patient’s natural immune response, utilizing the manner in which the body mounts an anti-viral response to target and eliminate cancer cells. This treatment is fundamentally unique in three critical ways:

Use of Dendritic Cells Stimulated by Homologous Antigenic Loading (aka “Double-Loaded” Dendritic Cells): The autologous dendritic cell product is loaded ex vivo with autologous tumor mRNA and lysate containing MHC class I and II overlapping epitopes, mediating the activation of a highly-conserved, intrinsic signaling pathway that stimulates TH1 immunity.

Administration in the Vicinity of the Tumor Draining Lymph Nodes: By means of ultrasound sonography, the autologous dendritic cells are introduced near the deep cervical lymph nodes, the lymphatic chains that drain the CNS. This procedure permits responding T-cells to be specifically-targeted for extravasation at the CNS microvasculature.

Augmenting the Anti-Viral Response: Autologous dendritic cells are introduced to the patient in conjunction with systemic delivery of type I interferon to prepare the cancer cells for immune attack via upregulation of MHC class I molecules and activation of the immunoproteasome.

Currently, access to our Dendritic Cell Therapy can be obtained through enrollment in one of our clinical studies for Glioblastoma Phase 2 (NCT06805305) and Pancreatic Adenocarcinoma (NCT04157127). The objective of these clinical studies is to evaluate patient safety and efficacy.

For patients who do not qualify for the existing clinical trials, Diakonos may open an expanded access program for the dendritic cell therapy prior to approval. Currently, we do not have expanded access program open for our investigational product.