On May 1, 2026 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported the presentation of new clinical data for DOC1021 (dubodencel), a first-in-class, patient-derived double-loaded dendritic cell investigational therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California, and at the American Academy of Neurology (AAN) Annual Meeting in Chicago, Illinois. The AACR (Free AACR Whitepaper) presentation features updated safety, survival, and immunologic data from the Company’s ongoing Phase 1 study in resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC), while the AAN presentation reports first results from the expanded access program (EAP) evaluating DOC1021 in combination with standard chemoradiation for adjuvant therapy of glioblastoma (GBM).
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"Presenting clinical data at both AACR (Free AACR Whitepaper) and AAN underscores the breadth of the DOC1021 platform across multiple hard-to-treat cancers with significant unmet need," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "We are encouraged by the survival and immune response signals observed across both studies, including the expanded access results in glioblastoma, where all treated patients have surpassed 12-month overall survival. These findings reinforce our confidence in DOC1021 as we advance into randomized Phase 2 evaluation in GBM and continue to expand the platform’s clinical potential across additional indications."
"The AACR (Free AACR Whitepaper) data highlight the potential of DOC1021 to drive durable immune responses in pancreatic cancer, one of the most challenging malignancies we treat," said Dr. Benjamin Musher, MD, Professor of Medicine at Baylor College of Medicine and the study’s principal investigator. "In the post-operative setting, we are observing encouraging signals, including a favorable safety profile and evidence of immune activation, including upregulation of cytotoxic and memory T-cell markers. We have also seen prolonged survival in some patients. While these findings are preliminary, they suggest DOC1021 may engage the immune system in a disease historically resistant to immunotherapy, thus warranting further clinical investigation."
Pancreatic Cancer (AACR) (Free AACR Whitepaper) Highlights
The Phase 1 study (NCT04157127) evaluates DOC1021 in patients with resectable or borderline resectable PDAC who have undergone surgical resection. In Group A, DOC1021 was administered after surgery and completion of adjuvant chemotherapy; in Group B, DOC1021 was administered after surgery but prior to adjuvant chemotherapy.
As of March 2026, 5 of 7 patients remain alive, with 3 relapse-free; post-operative survival ranges from ~20 to 56 months, with ongoing follow-up.
DOC1021 was well tolerated, with primarily Grade 1–2 flu-like symptoms, including headache, fatigue, chills, and fever; no dose-limiting toxicities (DLTs) observed.
Increased granzyme B in CD8+ T cells and IFN-γ in CD4+ effector memory T cells, indicating enhanced cytotoxic functionality.
Increased CD127 expression was observed on circulating CD8+ and CD4+ T cells post-vaccination in most patients, consistent with upregulation of effector memory phenotypes.
Group B, evaluating DOC1021 administration post-surgery but prior to adjuvant therapy, is currently enrolling. A high-dose cohort (12 x 106 cells per administration) is planned, supported by the DLT evaluation from the current low-dose cohort and additional safety data from a completed Phase 1 trial (NCT04552886) and the ongoing Phase 2 trial (NCT06805305) in glioblastoma.
Glioblastoma (AAN) Highlights
The expanded access protocol evaluated DOC1021 in adult patients with new or recurrent GBM. Following surgical resection and standard chemoradiation, patients received 3 doses of DOC1021 (36 x 106 total cells) injected bilaterally near the deep cervical node chains every other week, administered concurrently with 6 weekly doses of interferon. Patients were treated from November 2024 through July 2025.
Seven patients (5 newly diagnosed, 2 recurrent) completed all three doses following surgery and chemoradiation; median age was 57.0 years; 5 of 7 patients were MGMT unmethylated.
All patients exceeded 12-month overall survival (OS), comparing favorably to the 88% 12-month OS observed in the Phase 1 study and to the ~60% historical benchmark with standard of care.
For the 2 recurrent GBM patients, post-operative survival from the time of second surgery is 18.5 and 22 months.
For the 5 newly diagnosed patients, post-operative survival from the time of initial surgery ranges from 12.1 to 15.2 months.
DOC1021 was safe and feasible to administer. The most common treatment-related adverse events were mild injection site reactions (Grade 1–2).
Increased CD127 expression on CD8+ (p < 0.05) and CD4+ (p < 0.001) T cells post-vaccination supports immune memory and persistence.
Randomized Phase 2 trial is enrolling to evaluate DOC1021 plus standard of care versus standard of care alone after surgical resection in newly diagnosed GBM patients.
Poster Presentation Details:
AACR Annual Meeting (San Diego, CA)
Title: Clinical and Immunologic Assessment of DOC1021 Dendritic Cell Therapy in Resectable or Borderline Resectable Pancreatic Cancer
Authors: Konduri, V., Trivedi, A., Liu, W., Namekar, M., Ernste, K., Wilson, G. G., Duus, E. M., Armaghany, T., Makawita, S. U., Camp, E. R., Van Buren, G., Aguilar, L. K., Musher, B. L., and Decker, W. K.
AAN Annual Meeting (Chicago, IL)
Title: DOC1021 Cell-based Immunotherapy in Combination with Standard Chemoradiation for Adjuvant Therapy of Glioblastoma: Early Results from an Expanded Access Protocol of a Phase I Trial
Authors: Zhu, J‑J., Esquenazi‑Levy, Y., Hsu, S., Vu, M., Zvavanjanja, R. C., Trivedi, A., Liu, W., Namekar, M., Ernste, K., Tandon, N., Schumann, E. H., Duus, E. M., Aguilar, L. K., Georges, J. F., Konduri, V., and Decker, W. K.
About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that 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, a physiologic mimic of viral infection, unlocks a synergistic and exponentially more powerful tumor killing response that permits complete targeting of the total cancer antigen pool. Moreover, the approach does not require any molecular modification or genetic engineering of the patient’s immune cells and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 is designed for outpatient administration and broad access via community cancer centers.
Diakonos currently has three actively enrolling clinical trials evaluating DOC1021, including a Phase 1 pancreatic cancer study (NCT04157127), a Phase 2 glioblastoma (GBM) study (NCT06805305) and a Phase 1/2 study in refractory melanoma (NCT07288112) supported by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma, reflecting the significant unmet medical need across these indications. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.
(Press release, Diakonos Oncology, MAY 1, 2026, View Source [SID1234665011])