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Diakonos Oncology Wraps Up Enrollment for Phase 1 Glioblastoma Trial and Secures FDA Orphan Drug Designation

Tuesday, January 02, 2024

Diakonos Oncology Corporation, a company focused on immuno-oncology, has announced the successful completion of enrollment for its Phase 1 trial of DOC1021, a dendritic cell vaccine for Glioblastoma Multiforme (GBM). The trial, initiated in October 2021 with 16 patients across four dose levels, has shown promising results with no serious adverse events attributed to DOC1021. Notably, 13 out of the 16 patients are still alive, and the majority remain free of disease progression.

Diakonos CEO Mike Wicks emphasized the importance of achieving strong safety and efficacy signals in completing the Phase 1 trial. He stated that the company's focus is now on manufacturing optimization with Cellipont Bioservices and enrolling additional sites for the upcoming Phase 2 trial.

DOC1021 has also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for malignant glioma, including treatment for newly diagnosed/refractory GBM. Chief Regulatory Officer Ian Bellayr highlighted the significance of this designation, indicating its potential applicability to broader oncological indications. He expressed Diakonos' commitment to leveraging FDA programs for expedited development as more safety and efficacy data are accumulated over time.

The FDA orphan drug designation offers benefits such as seven years of marketing exclusivity, tax credits, user fee waivers, and federal grants to support clinical trials.

Glioblastoma Multiforme is a common and highly lethal malignant brain tumor, with a median survival of 15 to 21 months and only 7% of patients surviving more than five years, despite aggressive management.

Diakonos employs a unique approach to dendritic cell vaccines, utilizing a patient's dendritic cells and a sample of their tumor, enabling targeting of the complete cancer antigen profile without genetic modification. Inspired by how dendritic cells detect viral threats, the vaccines aim to stimulate a natural immune response to eliminate cancer cells and prevent recurrence.

In addition to the Phase 1 trial for GBM (NCT04552886), Diakonos has two other vaccines in clinical development for pancreatic cancer (NCT04157127) and angiosarcoma (NCT05799612), demonstrating the company's commitment to advancing cancer treatment options.



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