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Diakonos Oncology's Innovative Dendritic Cell Vaccine Shows Improved Survival Rates in Phase 1 Trial for Glioblastoma Compared to Standard Treatments

Wednesday, April 10, 2024

Diakonos Oncology Corp., a clinical-stage immuno-oncology company, revealed today an interim analysis of the Phase 1 open label trial of DOC1021, indicating significantly extended survival among glioblastoma multiforme (GBM) patients beyond the anticipated median overall survival (mOS) of 12.7 months for those receiving the standard of care (SOC). The median overall survival for newly diagnosed GBM patients in the trial has not yet been determined, with 88% of evaluable patients surviving at 12 months.

These findings were presented in a poster at the 2024 American Association for Cancer Research annual meeting. Out of 16 patients with newly diagnosed GBM, 12 remain alive with no serious adverse events attributed to DOC1021. Consequently, DOC1021 has been granted Fast Track and Orphan Drug designations by the FDA.

Mike Wicks, CEO of Diakonos, stated, "These very encouraging results support our confidence in the potential for our dendritic cell vaccines to significantly improve the lives of patients with the most deadly cancers. DOC1021 is a first-of-its-kind dendritic cell vaccine that represents an entirely new strategy for engaging a complete immune response against a patient’s cancer."

The ongoing analysis, presented on April 8, 2024, also indicates that with an average 12.9 months of follow-up among the 16 newly diagnosed GBM patients enrolled, the median overall survival has not yet been determined. Diakonos anticipates initiating Phase 2 trials of DOC1021 for GBM patients within the next year and is conducting two other clinical development programs in pancreatic cancer (NCT04157127) and angiosarcoma (NCT05799612).

Both newly diagnosed and recurrent GBM patients were enrolled in the Phase 1 study (NCT04552886) and received DOC1021 across four dose levels following SOC treatment. The first GBM patient enrolled in October 2021 survived more than two years. Each of the next four patients enrolled survived more than 15 months, and two remain alive at 20.3 months and 17.5 months, despite receiving less than 25% of the projected therapeutic dose.

Additionally, Diakonos’ trial has been commended for its inclusive trial design. Fifty-six percent of patients enrolled likely would have been excluded from other GBM clinical trials due to issues such as progression prior to treatment, subtotal resection status, or advanced age. Despite their challenging prognosis, these patients saw a statistically significant improvement in expected overall survival of 7.7 months for similar patients. The trial did exclude patients with IDH mutation status as such patients are no longer classified as GBM.

Diakonos’ dendritic cell vaccines are made with a patient’s own immune cells combined with RNA and proteins prepared from a sample of their tumor. This unique approach allows targeting of the complete cancer antigen profile without any genetic modification. Based on a discovery that unlocks the antiviral immune response, the vaccines harness a powerful natural immune signaling pathway that targets and eliminates cancer cells as if they were virally infected.



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