Diakonos Finishes GBM Trial Enrollment; Earns FDA Orphan Status

Diakonos Oncology Corporation, a clinical-stage immuno-oncology firm, has successfully completed patient enrollment for its Phase 1 clinical trial of DOC1021, a novel dendritic cell vaccine designed for the treatment of Glioblastoma Multiforme (GBM). The trial, which began with the first patient's enrollment in October 2021, has administered the vaccine to 16 individuals across four different dosage levels.

Early findings suggest that DOC1021 is safe and well-tolerated, as no serious adverse events have been attributed to the vaccine. Encouragingly, the majority of the patients are still alive and showing no signs of disease progression. Mike Wicks, CEO of Diakonos, highlighted the significance of the Phase 1 trial's success in terms of safety and efficacy, indicating a promising step forward for GBM patients.

The company is now focusing on optimizing the manufacturing process with Cellipont Bioservices and preparing for the Phase 2 trial by enrolling additional sites. DOC1021 has also been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of malignant glioma, including GBM. This designation not only provides an incentive for the development of drugs for rare diseases but also offers marketing exclusivity for seven years, along with tax credits and other support mechanisms.

GBM is recognized as the most aggressive and deadly form of brain cancer, with a low survival rate and a median survival time of 15 to 21 months. Despite current treatment options, long-term survival remains a challenge, with only 7% of patients living beyond five years.

Diakonos' dendritic cell vaccines are personalized, utilizing the patient's own dendritic cells and a sample of their tumor. This innovative method allows for a comprehensive targeting of the cancer's antigen profile without altering the patient's immune cells. The vaccines are based on the discovery of how dendritic cells identify viral threats, leveraging the body's natural immune response to target and eliminate cancer cells as if they were infected with a virus.

Research from Diakonos shows that this approach can elicit a robust killer T cell response and stimulate immunological memory, potentially preventing cancer recurrence. In addition to the GBM trial, Diakonos is also developing vaccines for pancreatic cancer and angiosarcoma, with clinical trials underway for both conditions.

Based in Houston, Texas, Diakonos Oncology is committed to advancing cancer immunotherapy, particularly for challenging indications such as GBM. The company's DOC1021 treatment platform is also in early-stage clinical testing for pancreatic ductal adenocarcinoma and cutaneous angiosarcoma.