#USA #San Diego #Glioblastoma #Diakonos Oncology #DOC1021

Diakonos Oncology Showcases Phase I Analysis of DOC1021

Diakonos Oncology, a pioneering biotechnology firm specializing in unique immunotherapies for hard-to-treat cancers, recently unveiled significant findings from their Phase I trial of DOC1021 at the 2025 American Academy of Neurology (AAN) Annual Meeting held in San Diego, California. This event, running from April 5 to 9, provided an esteemed platform for the presentation titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma."

Key Details of the Presentation

The presentation highlighted the results from an open-label Phase I trial designed to assess the safety, immunogenicity, and initial efficacy of DOC1021. Among the distinguished attendees was Diakonos Oncology's President and COO, Jay Hartenbach, who expressed the company’s commitment to developing innovative therapies to tackle the daunting challenges posed by glioblastoma, one of the most aggressive forms of cancer.

Encouraging Results

The preliminary results from the trial were promising, with 16 newly diagnosed glioblastoma patients enrolled. Notably, 94% (15 out of 16) of these patients had unmethylated MGMT, a common prognostic marker in glioblastoma patients. Among the key findings:

• - No adverse effects exceeding Grade 2 linked to the investigational procedure were witnessed, nor were there any dose-limiting toxicities (DLTs).
• - Significant immune activation was observed; 13 out of 13 patients exhibited expansion in CD4+ central memory T-cells post-vaccination, alongside 11 out of 13 showing similar results in CD8+ T-cells.
• - Additionally, a remarkable 12 out of 13 patients experienced expansion of CD8+CD127+ memory precursor effector cells, indicating a strengthened immune memory response.
• - Spatial transcriptomics analysis conducted on three patients revealed intense CD25+ foci that overlapped with effector memory T-cells and migratory microglial markers in the post-vaccination phase.
• - The one-year overall survival (OS) rate for the unmethylated cohort was impressive, standing at 88% in contrast to a mere 53% within a comparable age-matched control group, suggesting potential survival benefits associated with DOC1021 treatment.

Dr. Jay-Jiguang Zhu, the principal investigator of the study, lauded the trial's design and results, noting that the dendritic vaccine injections were well-tolerated with no observed serious side effects. He expressed excitement for future assessments and the upcoming Phase II trial to evaluate the impact of this dendritic cell-based vaccine therapy further.

An Innovative Therapeutic Approach

DOC1021 represents an autologous dendritic cell vaccine utilizing a proprietary loading technology to elicit a robust TH1 immune response against cancer. It is formulated from the patient's own dendritic cells combined with messenger RNA and proteins derived from their tumor specimens. This method enables a comprehensive attack on cancer cells by leveraging dual antigen sourcing—both protein and RNA—thus enhancing the immune response without necessitating modifications to the patient’s immune cells or intensive preconditioning treatments.

Beyond the glioblastoma study, Diakonos Oncology is also conducting a clinical trial of another dendritic cell vaccine aimed at treating pancreatic cancer. Recognizing the urgency and need for innovative cancer treatments, the FDA has granted Fast Track designations for both their glioblastoma and pancreatic cancer initiatives. Moreover, the glioblastoma program has been awarded Orphan Drug Designation, underscoring the program's significance in addressing an unmet medical need.

Conclusion

Based in Houston, Texas, Diakonos Oncology is on the cutting edge of cancer immunotherapy development. By targeting high-need cancers such as glioblastoma and pancreatic cancer through innovative approaches like DOC1021, the company aims to change the landscape of cancer treatment. For more in-depth information, visit www.diakonosoncology.com.