dubodencel (DOC1021) / APAC Biotech, Diakonos Research, Baylor College of Medicine - LARVOL DELTA

Experience of DOC1021 dendritic cell vaccine (dubodencel) in newly diagnosed and recurrent glioblastoma (SNO 2026) - No abstract available

Brain Cancer • Glioblastoma • Solid Tumor

Vaccination by homologous antigenic loading with DOC1021 as adjuvant therapy for glioblastoma: Phase I clinical trial results. (ASCO 2025) - P1 | " This clinical trial evaluated autologous DC vaccine DOC1021 prepared from mobilized peripheral blood mononuclear cells (PBMC), loaded with autologous tumor lysate and amplified tumor mRNA, and administered bilaterally near deep cervical lymph nodes... DOC1021 combined with SOC is safe and potentially efficacious in this challenging population that included subtotal resections, pre-treatment progression and 15/16 MGMT unmethylated. A randomized phase II trial is being launched including criteria to avoid early re-operation for enhancing T1-weighted signal that may be pseudo-progression."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • IL2RA • IL7R • ISG20 • MGMT

DECIST: Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Diakonos Oncology Corporation | Trial primary completion date: Jun 2026 ➔ Dec 2026

Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Diakonos Oncology Announces First Patients Dosed in Phase 1/2 DOC-RM Study of DOC1021 in Refractory Melanoma (The Manila Times) - "DOC-RM is a multicenter Phase 1/2 study (NCT07288112) evaluating safety, immune activity, and preliminary clinical efficacy of DOC1021 in patients with unresectable or metastatic melanoma who have progressed after prior therapies, including anti-PD-1 treatment."

Trial status • Melanoma

A phase I/II clinical study of DOC1021 (dubodencel) dendritic cell immunotherapy for refractory melanoma. (ASCO 2026) - P1, P1/2 | "The first patient to enroll in the Phase I safety study is planned for early 2026. Clinical trial information: NCT07288112."

Clinical • IO biomarker • P1/2 data • Brain Cancer • Cutaneous Melanoma • Glioblastoma • Melanoma • Pancreatic Cancer • Solid Tumor

Pooled analysis of phase I and expanded access study cohorts of DOC1021 (dubodencel) in combination with chemoradiation for glioblastoma. (ASCO 2026) - P1, P2 | "Collectively, the data show that DOC1021 plus SOC is well-tolerated, feasible, and potentially efficacious in a challenging population that included subtotal resections, pre-treatment progression, and majority MGMT unmethylated. A multi-center, randomized, open-label Phase 2 trial (NCT06805305) in newly diagnosed GBM is now enrolling to compare DOC1021+SOC vs SOC treatment alone."

Combination therapy • IO biomarker • P1 data • Retrospective data • Brain Cancer • Glioblastoma • Solid Tumor • CD4 • CD8 • IL7R • MGMT

Natera Announces Collaboration with Diakonos Oncology for Signatera in Refractory Melanoma (Yahoo Finance) - "As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial...The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel)...With Signatera, Natera will conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment."

Diagnostic • Licensing / partnership • Trial status • Melanoma

Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma (PRNewswire) - "Building on this regulatory milestone, Diakonos plans to advance DOC1021 through ongoing and upcoming clinical studies, including the Phase 1/2 trial in refractory melanoma, which is now recruiting."

Fast track • Melanoma

Diakonos Oncology Reports Positive Clinical Data from…Expanded Access Program in Glioblastoma at…AAN 2026 (PRNewswire) - "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."

Clinical data • Glioblastoma

Diakonos Oncology Reports Positive Clinical Data from Phase 1 Pancreatic Cancer Study…at AACR…2026 (PRNewswire) - "The Phase 1 study (NCT04157127) evaluates DOC1021 in patients with resectable or borderline resectable PDAC who have undergone surgical resection....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."

P1 data • Pancreatic Adenocarcinoma

Clinical and immunologic assessment of DOC1021 dendritic cell therapy in resectable or borderline resectable pancreatic cancer (AACR 2026) - "DOC1021 immunotherapy can be safely delivered after resection of PDAC and standard perioperative therapy with encouraging survival outcomes. Immune profiling revealed increases in MPECs and functional T cell markers, consistent with other DOC1021 studies. A second study arm evaluating vaccination post-surgery but prior to adjuvant therapy is now open and accruing."

Clinical • IO biomarker • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD4 • CD8 • GZMB • IFNG • IL7R

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 (AAN 2026) - P2 | "One patient developed grade 3 cerebral edema after the first DOC1021 dose, recovered, and completed subsequent doses as planned, reflecting a transient treatment-emergent immune response and/or aggressive dexamethasone taper...Conclusions Administration of DOC1021 after resection and SOC is safe, feasible, and potentially efficacious in patients diagnosed with glioblastoma, confirming Phase I trial results. A multi-center, randomized, open-label Phase 2 trial for newly diagnosed glioblastoma patients (NCT06805305) is now enrolling."

Clinical • Combination therapy • P1 data • Brain Cancer • Glioblastoma • Solid Tumor • CD8 • MGMT

Phase I Clinical Study of DOC1021 (dubodencel) for Adjuvant Immunotherapy of Glioblastoma. (PubMed, medRxiv) - P2 | "DOC1021 was safe, feasibly integrated within SOC, and associated with more favorable outcomes in this challenging patient population. Patients who received observation rather than reoperation for worsening MRI contrast-enhancement exhibited superior survival, suggesting an immune-reactive tumor microenvironment manifesting as pseudo-progression. These data supported initiation of a randomized Phase II trial ( NCT06805305 ) for nGBM."

Journal • P1 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • MGMT

Diakonos Oncology to Showcase DOC1021 (dubodencel) Clinical Data in Pancreatic Cancer and Glioblastoma at AACR and AAN 2026 (PRNewswire) - "Both conferences will feature clinical data on DOC1021 (dubodencel), a first-in-class, patient-derived double-loaded dendritic cell investigational therapy, with AACR focusing on pancreatic ductal adenocarcinoma and AAN on glioblastoma."

Clinical data • P1 data • Glioblastoma • Pancreatic Cancer

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Diakonos Oncology Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

Diakonos Oncology Announces Study to Continue after First DSMB Safety Review of DOC1021 in Phase 2 GBM Study (PRNewswire) - "The DSMB's recommendation followed a review of available safety data from patients randomized in the DOC-GBM2 study. Approximately six months after the first patient was treated, the committee reported that no safety concerns have been identified to date and that no changes to the study design are warranted."

DSMB • Glioblastoma

DOC1021 Dendritic Cell Immunotherapy for Refractory Melanoma (clinicaltrials.gov) - P1/2 | N=35 | Not yet recruiting | Sponsor: Diakonos Oncology Corporation

New P1/2 trial • Melanoma • Oncology • Solid Tumor

Diakonos Oncology Awarded Multi-Million-Dollar Research Grant by the Cancer Prevention and Research Institute of Texas to Advance DOC1021 in Refractory Melanoma (PRNewswire) - "CPRIT award exceeds $7 million, with Diakonos selected as one of only nine awardees from a pool of 164 applicants. Funding will support advancing DOC1021 into a Phase 1/2 clinical trial for patients with refractory melanoma....Enrollment in the Phase 1 clinical study of DOC1021 for patients with refractory melanoma is expected to begin in January 2026..."

Financing • New P1/2 trial • Melanoma

Diakonos Oncology to Present Corporate Overview and Participate in Panel at 2026 Biotech Showcase (PRNewswire) - "Diakonos Oncology will be represented by Jay Hartenbach, President and COO, who will provide a company presentation on the latest clinical developments of DOC1021, a first-in-class, patient-derived double-loaded dendritic cell investigational therapy for aggressive cancers."

Clinical data • Solid Tumor

Diakonos Oncology Presents Promising Preliminary Data from Phase 1 Study of DOC1021 Cell-Based Immunotherapy in Pancreatic Cancer at Society for Immunotherapy of Cancer 40th Annual Meeting (PRNewswire) - "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....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."

P1 data • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Phase I Trial of DOC1021 Cell-Based Immunotherapy for Resectable or Borderline Resectable Pancreatic Ductal Adenocarcinoma (SITC 2025) - "Joel M. Sederstrom.Ethics Approval This study is being completed under oversight from the WCG institutional review board (reference #20192574), the Baylor College of Medicine institutional review board, an independent data safety monitoring board, and the Food and Drug Administration. All patients provided written, informed consent prior to enrollment."

IO biomarker • P1 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CD8

Pancreatic Cancer Clinical Trial Data for Diakonos Oncology's DOC1021 Cell-Based Immunotherapy to be Presented at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting (PRNewswire) - "...'We are now excited to share preliminary data in pancreatic cancer'."

P1 data • Pancreatic Ductal Adenocarcinoma

DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Diakonos Oncology Corporation | N=135 ➔ 180

Enrollment change • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Diakonos Oncology Announces First Patient Dosed in Phase 2 Clinical Trial Evaluating DOC1021 (dubodencel) for Glioblastoma (PRNewswire) - "Diakonos Oncology...announced 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. The first patient was dosed at City of Hope's main campus in Los Angeles, California....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."

Trial status • Glioblastoma

Diakonos Oncology Presents Promising Phase I Results of Dubodencel (DOC1021) for the Treatment of Glioblastoma at the ASCO 2025 Annual Meeting (PRNewswire) - P1 | N=17 | NCT04552886 | "Key findings included: (i) Excellent Safety Profile: The most common adverse events (AEs) were mild flu-like symptoms and injection-site reactions, with no dose-limiting toxicities reported; (ii) Immune Response: Post-vaccination analysis showed significant expansion of CD4+ and CD8+ central memory T-cell compartments in 13 of 13 and 11 of 13 patients, respectively. Spatial transcriptomics in tumor samples from three patients revealed clusters or 'immune triads' consisting of activated CD4, CD8 and migratory microglial cells, that were increased in frequency and density post-injection...; (iii) Improved Survival: The 12-month overall survival (OS) rate was 88%, significantly higher than the expected ~60% for standard of care and four patients are still alive at 22-33 months of follow-up. Recurrent glioblastoma patients survived 10-12 months."

P1 data • Glioblastoma