On April 9, 2025 Diakonos Oncology, a clinical-stage biotechnology company developing innovative immunotherapies for difficult-to-treat cancers, reported the successful presentation of an abstract at the 2025 American Academy of Neurology (AAN) Annual Meeting, which took place April 5-9, 2025, in San Diego, California (Press release, Diakonos Oncology, APR 9, 2025, View Source [SID1234651860]). The abstract presentation, titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma", featured promising data from an open-label Phase I trial evaluating the safety, immunogenicity, and early efficacy signals of DOC1021.
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"We were honored to present our latest research at the American Academy of Neurology Annual Meeting," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have the potential to make a meaningful impact for patients. The results of this Phase I analysis are highly encouraging and reinforce the potential of DOC1021 as a novel immunotherapy for glioblastoma."
Abstract Presentation Details:
Title: Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma
Authors: Zhu J-J, Esquenazi-Levy Y, Hsu S, Zvavanjanja RC, Vu M, Schumann EH, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste K, Mossop C, Clay CM, Amin S, Ravi V, Kemnade JO, Aguilar LK, Turtz A, Tandon N, Konduri V, Georges JF, Decker WK
Session: S29 – Neuro-oncology
Date and Time: Tuesday, April 8, from 4:06-4:18 p.m. PT
Location: San Diego Convention Center, 25C
Key Highlights:
DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated.
No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed.
CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation.
CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential.
Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination.
One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit.
"In the Phase I trial, the dendritic vaccine injections at the lymph nodes were well tolerated, with no significant side effects observed in any participants," said Dr. Jay-Jiguang Zhu, Principal Investigator of the study and Professor and Director of Neuro-oncology at UTHealth Houston. "We are looking forward to assessing this dendritic cell-based vaccine therapy in the upcoming Phase II trial."
About DOC1021
DOC1021 is an autologous dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. The vaccines are made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patients’ tumor specimens.
This unique approach unlocks a synergistic 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 of bone marrow or high dose IL-2 for administration.
In addition to the lead GBM study, a clinical trial of another Diakonos dendritic cell vaccine is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.