- Independent Data Safety Monitoring Board recommends continuation of Phase 2 GBM trial without modification
HOUSTON, Feb. 17, 2026 /PRNewswire/ -- Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing Phase 2 DOC-GBM2 clinical trial of DOC1021 in patients with newly diagnosed glioblastoma (GBM) has completed a scheduled safety review and recommended that the study continue as planned.
The DSMB's recommendation followed a review of available safety data from patients randomized in the DOC-GBM2 study. Approximately six months after the first patient was treated, the committee reported that no safety concerns have been identified to date and that no changes to the study design are warranted.
"Ensuring patient safety remains central to our clinical development efforts, particularly in serious and hard-to-treat cancers such as glioblastoma," said Laura Aguilar, M.D., Ph.D., Chief Medical Officer at Diakonos Oncology. "It is reassuring to see a safety profile for DOC1021 in this study that is consistent with prior Phase 1 data, and the independent committee's recommendation to continue this Phase 2 trial without modification provides added confidence as we progress the development of DOC1021 for patients with glioblastoma."
About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely combines tumor lysate and amplified tumor-derived mRNA. The immunotherapy is made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumor specimens.
The unique double-loading approach, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient's immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.
Diakonos currently has two active clinical trials with DOC1021, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. A refractory melanoma Phase 1/2 study with DOC1021 (NCT07288112) will be initiated early this year with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).
About Diakonos Oncology Corp.
Based in Houston, Diakonos Oncology Corp. is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy with its proprietary double-loaded patient-derived dendritic cell therapeutic platform, focused on addressing the critical, unmet medical needs for treatment of late-stage and aggressive cancers. For more information visit: https://www.diakonosoncology.com
Media Contact:
David Schull
Russo Partners
858-717-2310
david.schull@russopartnersllc.com
Jay Hartenbach
Diakonos Oncology
pr@diakonosoncology.com
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SOURCE Diakonos Oncology
