HOUSTON, Nov. 7, 2025 /PRNewswire/ — Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced the presentation of Phase 1 data on DOC1021, a patient-specific dendritic cell therapy, in pancreatic ductal adenocarcinoma (PDAC) at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, being held November 7-9 in National Harbor, MD.
DOC1021 was administered after neoadjuvant chemotherapy, surgery and adjuvant chemotherapy in the first group of patients. The treatment was well tolerated, with no dose-limiting toxicities observed. Favorable biomarker signatures and a promising survival signal were also seen, with five of seven patients remaining alive.
“Pancreatic cancer patients face a poor prognosis with few effective treatment options”, said Jay Hartenbach, President and COO of Diakonos Oncology. “We are encouraged by these results for DOC1021, a novel and highly targeted approach which activates the patient’s own immune system in a specific manner against their cancer”.
Key findings presented included:
- Five of seven treated patients (3 of whom remain relapse-free) remain alive with post-operative survival times of 12.9 to 45.3 months; survival status continues to be monitored.
- No dose-limiting toxicities were observed.
- Most common adverse events were mild flu-like symptoms.
- Post-vaccination CD127 upregulation on circulating T-cells and Granzyme B upregulation in circulating CD8+ cells were observed, suggesting enhanced T cell activity.
“Given the ongoing need for and growing excitement surrounding personalized tumor vaccination following resection of pancreatic cancer, we are very excited to continue enrolling patients in this very important trial”, said Dr. Benjamin Leon Musher, Professor of Medicine-Hematology & Oncology, Barry Stephen Smith Memorial Endowed Professor, and Medical Director of Medical Oncology of the Dan L Duncan Comprehensive Cancer Center at the Baylor College of Medicine. “We are now enrolling a second group of patients where DOC1021 is given after surgery before adjuvant chemotherapy, and we look forward to further evaluation of this approach.”
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 Phase I pancreatic cancer study (NCT04157127), Diakonos recently opened a Phase 2 glioblastoma (GBM) study with DOC1021 (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 has also received Orphan Drug Designation for the GBM program in January 2024.
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
[email protected]
Jay Hartenbach
Diakonos Oncology
[email protected]
SOURCE Diakonos Oncology
