On January 2, 2024 Diakonos Oncology Corporation ("Diakonos"), a clinical stage immuno-oncology company, reported that it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme (GBM). With the first patient enrolled in October 2021, DOC1021 has been administered to 16 patients across four dose levels (Press release, Diakonos Oncology, JAN 2, 2024, View Source [SID1234638888]).
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To date, DOC1021 appears to be very safe and well tolerated as there have been no attributable serious adverse events observed from DOC1021. Additionally, 13 out of 16 patients remain alive today with the vast majority of patients still progression free.
"Completing the Phase 1 trial with both strong safety and efficacy signals was a critical step towards providing DOC1021 to all GBM patients," said Mike Wicks, Chief Executive Officer of Diakonos, "Our focus now shifts towards manufacturing optimization underway with Cellipont Bioservices and enrolling additional sites for the upcoming Phase 2 trial."
Additionally, DOC1021 also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for malignant glioma, including treatment of newly diagnosed/refractory glioblastoma multiforme (GBM).
"Receiving the Orphan Drug Designation from the FDA is a valuable addition to our existing Fast Track Designation as it indicates that the cell therapy may be more broadly applicable to other oncological indications," said Ian Bellayr, PhD, Chief Regulatory Officer of Diakonos, "As we continue to accumulate more safety and efficacy data with time, Diakonos will continue to leverage other FDA programs to expedite development."
The FDA orphan drug designation provides seven years of marketing exclusivity along with other incentives such as tax credits, user fee waivers and federal grants to support clinical trials.
GBM is the most common and lethal malignant brain tumor with an annual incidence of 3.19 per 100,000 persons in the U.S. Despite aggressive management, median survival remains between 15 – 21 months with only 7% of patients surviving more than five years.
Diakonos’ dendritic cell vaccines are made with a patient’s dendritic cells and a sample of their tumor. This unique approach allows targeting of the complete cancer antigen profile without any genetic modification of the patient’s immune cells. Based on a discovery on how dendritic cells detect viral threats, the vaccines harness a natural immune response that targets and eliminates cancer cells as if they were virally infected.
Diakonos research indicates this approach generates a strong killer T cell response and stimulates immunological memory aimed at preventing the cancer’s recurrence. In addition to the Phase 1 trial of DOC1021 for GBM (NCT04552886), the company has two other vaccines in clinical development for pancreatic cancer (NCT04157127) and angiosarcoma (NCT05799612).