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

Clinical and immunologic assessment of DOC1021 dendritic cell therapy in resectable or borderline resectable pancreatic cancer (AACR 2026) - "Abstract is embargoed at this time."

Clinical • Oncology • Pancreatic Cancer • Solid Tumor

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... 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

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

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

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

Diakonos Oncology secures $20m for Phase II trial of glioblastoma treatment (Clinical Trials Arena) - "US-based biotechnology company Diakonos Oncology has closed a $20m private placement of Simple Agreements for Future Equity (SAFE) to expedite its Phase II glioblastoma trial of dubodencel. The company will also use the funding to expand its clinical portfolio into new indications such as refractory melanoma. The funding includes contributions from new investors such as Baylor College of Medicine and the Brain Tumor Investment Fund, as well as current shareholders such as the company’s CEO Mike Wicks."

Financing • Glioblastoma • Melanoma

DECIST: Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Diakonos Oncology Corporation | Active, not recruiting ➔ Recruiting | N=43 ➔ 18 | Trial primary completion date: Jan 2026 ➔ Jun 2026

Enrollment change • Enrollment open • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4

Diakonos Oncology to Present Phase I Results of Dubodencel (DOC1021), a Double-Loaded Dendritic Cell Therapy for Glioblastoma, at the ASCO 2025 Annual Meeting (PRNewswire) - "Diakonos Oncology...announced that it will present new clinical data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL. The presentation, titled 'Vaccination by homologous antigenic loading with DOC1021 as adjuvant therapy for glioblastoma: Phase I clinical trial results', will highlight findings from the company's Phase I trial of Dubodencel (DOC1021), a double-loaded dendritic cell therapy being evaluated for the treatment of glioblastoma, a highly aggressive brain tumor with a median overall survival of 14-18 months despite standard care. The study, recently completed, offers hope for improving outcomes in this devastating disease."

P1 data • Glioblastoma

Diakonos Oncology Presents Phase I Analysis of DOC1021 at the 2025 American Academy of Neurology Annual Meeting (PRNewswire) - P1 | N=17 | NCT04552886 | "DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated. No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed. CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation. CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential. Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination. One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit."

P1 data • Glioblastoma

Dendritic Cell Immunotherapy for Treatment of Adult GBM (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Diakonos Oncology Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Phase I Analysis of DOC1021, A Cell-based Vaccination Platform for Adjuvant Therapy of Glioblastoma (AAN 2025) - "Objective:We report ongoing results of an open-label phase I trial in which DC vaccines prepared through homologous antigenic loading were administered to patients with newly diagnosed glioblastoma.Background:Glioblastoma is a devastating tumor with median survival of 14-18 months despite aggressive intervention...The results suggest that DOC1021 is safe, immunogenic, potentially efficacious, and can be effectively integrated within existing standards of care."

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

Dendritic Cell Immunotherapy for Treatment of Adult GBM (clinicaltrials.gov) - P2 | N=135 | Not yet recruiting | Sponsor: Diakonos Oncology Corporation

New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Diakonos Oncology to Present at Biotech Showcase 2025 (PRNewswire) - "Diakonos Oncology...announced that it will present its latest developments at the Biotech Showcase in San Francisco, CA from January 13-15, 2025....Diakonos Oncology will be represented by President and Chief Operating Officer Jay Hartenbach, who will be presenting on recent corporate milestones and research developments, including lead product DOC1021, a unique autologous dendritic cell vaccine (DCV), which will begin enrolling patients in its Phase 2 clinical trial for glioblastoma (GBM) in H1 2025 at leading treatment centers across the US."

New P2 trial • Glioblastoma

DOC1021 cell-based vaccination as adjuvant therapy for glioblastoma: phase I clinical trial analysis (SNO 2024) - "Median survival for the MGMTp unmethylated cohort (n=15) has not yet been reached but is statistically greater (p<0.05) than that of matched historic controls. The results indicate that DOC1021 is safe, can be effectively integrated within existing standards of care and is potentially efficacious in a challenging patient population."

Clinical • P1 data • Brain Cancer • CNS Tumor • Dermatology • Fatigue • Glioblastoma • Immunology • Oncology • Solid Tumor • Urticaria • CD4 • CD8 • IL7R • MGMT

Vaccination by homologous antigenic loading as adjuvant therapy for glioblastoma: correlation of immune response and early efficacy signal with vaccine cell gene signature (SITC 2024) - P1 | "Methods This phase I clinical trial evaluated the autologous DC vaccine DOC1021 prepared through homologous antigenic loading of DC with autologous tumor lysate and amplified mRNA and administered bilaterally near the deep cervical lymph node chains...Vaccine gene signature correlation with peripheral immune responseDownload figure Open in new tab Download powerpoint Abstract 590 Figure 3 Vaccine gene signature correlation with peripheral immune response. Survival comparison to recent historical cohort by Kaplan-Meier analysisDownload figure Open in new tab Download powerpoint Abstract 590 Figure 4 Survival comparison to recent historical cohort by Kaplan-Meier analysis"

Clinical • Gene Signature • IO biomarker • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • GZMB • IL7R • KLRB1 • MGMT

DECIST: Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=43 | Active, not recruiting | Sponsor: Baylor College of Medicine | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4