Diakonos Oncology reports that an interim analysis of a Phase I open label trial of its dendritic cell vaccine (DOC1021) showed substantially increased survival of glioblastoma multiforme (GBM) patients beyond the expected median overall survival (mOS) of 12.7 months for patients receiving the standard of care (SOC). 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 percent.

The analysis was presented in a poster at the American Association for Cancer Research Annual Meeting in San Diego. 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.”

Phase II trials expected to begin next year

Findings from the ongoing analysis 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 II trials of DOC1021 for GBM patients within the next year and is conducting two other clinical development programs in pancreatic cancer and angiosarcoma.

Both newly diagnosed and recurrent GBM patients were enrolled in the Phase I study 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 percent of the projected therapeutic dose.

In addition, Diakonos’ trial has been commended for its inclusive trial design, according to company officials. 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, notes Wicks, 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 approach allows targeting of the complete cancer antigen profile without any genetic modification.

Previous articlePlatform Processes May Reduce AAV Gene Therapy Costs
Next articleAI-Driven Drug Discovery Straddles the Virtual and the Real