Diakonos Oncology, a clinical-stage biotechnology company focused on next-generation immunotherapies for aggressive cancers, has announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing Phase II DOC-GBM2 trial has recommended the study continue as planned following a scheduled safety review.

The DSMB evaluated available safety data from patients enrolled in the Phase II trial of DOC1021 in newly diagnosed glioblastoma. Approximately six months after the first patient received treatment, the board reported no identified safety concerns and determined that no modifications to the study design were necessary.

 Laura Aguilar, Chief Medical Officer at Diakonos Oncology, said, “Ensuring patient safety remains central to our clinical development efforts, particularly in serious and hard-to-treat cancers such as glioblastoma.” She added that the observed safety profile of DOC1021 in the Phase II study is consistent with prior Phase I findings, reinforcing confidence in advancing the programme.

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy designed to trigger a robust immune response against tumours. The therapy combines tumour lysate and amplified tumour-derived mRNA prepared from a patient’s own tumour specimen and dendritic cells. The approach aims to generate a strong TH1 immune response while targeting the full spectrum of cancer antigens.

Unlike some cell-based therapies, DOC1021 does not require genetic modification of immune cells, preconditioning chemotherapy, or high-dose interleukin-2 (IL-2). It is designed for outpatient administration and broader accessibility through community cancer centres.

Diakonos is currently advancing two clinical programmes with DOC1021: a Phase I pancreatic cancer trial and the ongoing Phase II glioblastoma study. The company has received Fast Track designation from the U.S. Food and Drug Administration for both its GBM and pancreatic cancer programmes, as well as Orphan Drug Designation for the GBM programme.

Additionally, a Phase I/II trial in refractory melanoma is expected to begin early this year with support from the Cancer Prevention and Research Institute of Texas.