On April 9, 2024 Diakonos Oncology Corp., a clinical-stage immuno-oncology company, reported an interim analysis of the Phase 1 open label trial of DOC1021 showing substantially increased survival of glioblastoma multiforme (GBM) patients well beyond the expected median overall survival (mOS) of 12.7 months for patients receiving the standard of care (SOC) (Press release, Diakonos Oncology, APR 9, 2024, View Source [SID1234641970]). The median overall survival for the trial of newly diagnosed GBM has not yet been reached with 12-month survival among evaluable patients currently is 88%.
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The analysis was presented in a poster at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021. As a result, DOC1021 has received Fast Track and Orphan Drug designations from the FDA.
"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," said Mike Wicks, Diakonos CEO. "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."
Findings from the ongoing analysis, presented April 8, 2024 at AACR (Free AACR Whitepaper), also reveal that with an average 12.9 months of follow up among the 16 newly diagnosed GBM patients enrolled in the study, median overall survival has yet to be reached. The company expects to begin 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.
In addition, Diakonos’ trial has been commended on 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.