On July 22, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported that the first patient has been dosed in its Phase 2 clinical trial evaluating DOC1021, an investigational patient-derived double-loaded dendritic cell therapy for glioblastoma (GBM), a highly aggressive primary brain tumor (Press release, Diakonos Oncology, JUL 22, 2025, View Source [SID1234654474]).
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The first patient was dosed at City of Hope’s main campus in Los Angeles, California. City of Hope is one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report.
"City of Hope leads groundbreaking clinical research that has resulted in therapies like CAR T cell immunotherapy and novel drug discoveries – new treatments that are addressing even the most challenging cancers. Glioblastoma is an aggressive tumor that is difficult to treat because the tumors often are resistant to existing treatments. We need to create more effective therapies for this deadly disease," said Jana Portnow, M.D., City of Hope medical oncologist and co-director of its Brain Tumor Program.
This study (ClinicalTrials.gov Identifier: NCT06805305) is designed to evaluate the safety, tolerability, and efficacy of DOC1021 in combination with standard-of-care (SOC) treatment versus SOC alone in adult patients newly diagnosed with glioblastoma (IDH-wildtype). The trial is expected to open at approximately 20 centers in the United States, including Atlantic Health System and UTHealth Houston, that opened recently.
"We are tremendously proud to announce the dosing of the first patient in this critical Phase 2 study, marking an important milestone in our mission to develop a much-needed treatment for patients with glioblastoma, a disease that, despite significant advances in neuro-oncology, remains one of the most challenging cancers to treat, with patient outcomes still falling short of expectations," said Dr. Laura Aguilar, Chief Medical Officer of Diakonos Oncology. "This Phase 2 trial represents an important step in evaluating DOC1021’s potential to enhance the immune response and work alongside standard therapies. We are optimistic that this approach could lead to meaningful improvements in survival and quality of life for patients facing this aggressive disease."
The trial’s primary outcome measure is overall survival (OS), with 1-, 2- and 3-year survival as secondary outcome measures, along with progression-free survival (PFS), number of adverse events, health-related quality of life, and neuro-cognitive function.
"As Diakonos’ CDMO partner, we’re thrilled to see this next phase of clinical development take shape," said Darren Head, CEO of Cellipont Bioservices. "Manufacturing patient-specific cell therapies like DOC1021 requires precision, flexibility, and deep scientific collaboration. We are proud to support Diakonos in advancing this novel immunotherapy and look forward to continuing our partnership as the trial progresses."
About Glioblastoma
Glioblastoma Multiforme (GBM) is the most common and aggressive primary malignant brain tumor in adults. There are about 15,000 new GBM patients diagnosed annually in the US. Standard treatment includes surgery, radiation, and chemotherapy, but the prognosis remains poor, with a median survival of approximately 15 months. There is a significant unmet need for new and effective treatments.
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 a simple administration in the outpatient setting and broad reach via community cancer centers.
In addition to the recently opened Phase 2 GBM study, a clinical trial of Diakonos’ DOC1021 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, in October 2023 and May 2024, respectively. The company has also received Orphan Drug Designation for the GBM program in January 2024.