This data was presented at the Congress of Neurological Surgeons held in Houston, Texas, from September 28 to October 2, 2024.
Initial analysis of results showed no dose-limiting toxicities or serious adverse events, with 14 of 15 evaluable patients alive at 12 months.
The Phase 2 trial for DOC1021 will begin in Q4 2024, with the first patient expected to receive treatment in Q1 2025.
HOUSTON, Oct. 1, 2024–(BUSINESS WIRE)–Diaconos Oncology Corporation, a clinical-stage immuno-oncology company, recently completed a Phase 1 open-label trial of DOC1021, a differentiated dendrite. announced positive data from interim analysis of the trial. Presented cell vaccines for the treatment of glioblastoma (GBM) at the Society of Neurological Surgeons Annual Meeting (September 28-October 2, 2024, Houston, Texas).
This analysis was included in a presentation titled “Vaccination with homologous antigen challenge as adjunctive therapy for glioblastoma: Initial analysis of phase 1 results.” The presentation was made by Dr. Joseph Georges, an investigator on the DOC1021 Phase 1 clinical trial and assistant professor of neurosurgery at the Medical College of Arizona, Phoenix.
“DOC1021 is the first double-filled dendritic cell vaccine of its kind that represents an entirely new strategy to generate a complete immune response against cancer in patients,” said Mike Wicks, CEO of Diaconos. Ta. “Based on the promising results of the Phase 1 trial, we plan to begin the Phase 2 trial in the fourth quarter of 2024.”
Sixteen patients with newly diagnosed GBM and two patients with relapsed GBM were enrolled in the phase 1 study. Patients received DOC1021 across four dose levels following standard of care (SOC) treatment. Exclusion criteria were minimal. Registration began in October 2021 and completed in December 2023.
In an analysis of newly diagnosed patients (94% (15/16) of whom had difficult tumors with unmethylated MGMT and generally poor prognosis), 93% (14 of 15 evaluable patients) ) were shown to have survived for more than 12 months. Furthermore, with current median follow-up of 16 months, median survival had not yet been reached.
An interim Kaplan-Meier (KM) analysis comparing treated patients to age-matched historical controls who received full standard of care showed a statistically significant difference between the groups (p=0.03). has been done. KM-predicted overall survival is currently 19.7 months, whereas the expected survival for unmethylated GBM patients receiving SOC is 12.7 months.
“Developing effective treatments for glioblastoma is a major clinical challenge,” said Dr. George. “We are very excited to be collaborating with the Decker Institute and Diaconos on this clinical trial. Our data show that this new vaccine is safe and has the potential to improve outcomes for glioblastoma patients. Dr. William Decker is the inventor of the DOC1021 technology and an associate professor of pathology and immunology at Baylor College of Medicine.
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About DOC1021
DOC1021 is an autologous dendritic cell vaccine (DCV) that mounts a complete cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double-loading technology. The vaccine is made by combining a patient’s dendritic cells with RNA and proteins prepared from tumor samples. This unique approach allows targeting the complete cancer antigen profile without any genetic modification of the patient’s immune cells.
In addition to the lead GBM study, clinical trials of another Diaconos dendritic cell vaccine for the treatment of pancreatic cancer are underway. Diaconos has received Fast Track designation from the FDA for both its GBM and pancreatic cancer programs. The company also has Orphan Drug Designation under the GBM Program.
About Diakonos Oncology Corp.
Diakonos Oncology, based in Houston, Texas, is a clinical-stage biotechnology company revolutionizing cancer immunotherapy and focused on hard-to-treat indications such as glioblastoma. A variant of the DOC1021 therapeutic platform is also in early-stage clinical trials for pancreatic ductal adenocarcinoma (PDAC). For more information, please visit www.diakonosoncology.com.
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