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

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

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

CNS 2024 Conference Presentation: Diakonos Oncology’s Autologous Dendritic Cell Vaccine (DOC1021) Yields 93% 12-Month Survival for Glioblastoma Patients (Businesswire) - P1 | N=17 | NCT04552886 | "Diakonos Oncology...presented positive data from an interim analysis of its recently completed Phase 1 open label study of DOC1021...at the Congress of Neurological Surgeons annual meeting....Sixteen newly diagnosed and two recurrent GBM patients were enrolled in the Phase 1 study....An analysis of the newly diagnosed patients - 94% (15/16) of whom had challenging tumors with unmethylated MGMT and generally poor prognosis - showed that 93% (14 of 15 evaluable patients) survived more than 12 months. Moreover, median survival had not yet been reached with median follow-up currently at 16 months. An interim Kaplan-Meier (KM) analysis comparing treated patients to age-matched historical controls who received full standard of care therapy indicates a statistically significant difference (p=0.03) between groups."

P1 data • Glioblastoma

Diakonos Oncology Announces Final Closing of Oversubscribed $11.4M Seed Financing to Advance Its Highly Differentiated Dendritic Cell Vaccine (DOC1021) into a Phase 2 Clinical Trial (Businesswire) - "Diakonos Oncology Corp...announced today the final closing of an oversubscribed seed financing of $11.4 million. The round was led by biotechnology investment firm Restem Group Inc., with participation from existing investors. To date, funds have enabled the company to establish manufacturing operations, add key leadership positions, and complete enrollment for the Phase 1 study of lead asset DOC1021 in the treatment of glioblastoma (GBM). The additional capital will fund operations into late 2025 and allow Diakonos to initiate the Phase 2 trial in GBM prior to closing a Series A round...'This investment will fund operations through the final readout of key safety and efficacy data from our Phase 1 trial and will allow the company to ramp up preparations for pipeline expansion and the initiation of our Phase 2 GBM trial which is expected to begin in the fourth quarter of this year.'"

Financing • New P2 trial • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Diakonos Oncology Receives FDA Fast Track Designation for Pancreatic Cancer Dendritic Cell Vaccine; Names Daniel D. Von Hoff, M.D. to Scientific Advisory Board (Businesswire) - "Diakonos Oncology Corporation...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s unique dendritic cell vaccine (DCV) for pancreatic ductal adenocarcinoma."

Fast track • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Diakonos Oncology CFO Anthony Baldor to Provide Corporate Update at BIO International Convention In San Diego, June 3 - 6, 2024 (Businesswire) - "Diakonos Oncology Corp...announced today that Chief Financial Officer and Head Of Business Development Anthony Baldor will give a company presentation at the 2024 BIO International Convention June 3 – 6, 2024 in San Diego. The corporate update will be June 4 at 3 pm PT in Company Presentation Theater 2 at the San Diego Convention Center. Mr. Baldor’s presentation will include a review of Diakonos’ highly differentiated double-loaded autologous dendritic cell vaccines for cancer, and an operational update on the company’s plans for growth, including clinical development outlook and expansion of its leadership team."

Clinical • Angiosarcoma • Brain Cancer • CNS Tumor • Gastrointestinal Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Diakonos Oncology’s Unique Dendritic Cell Vaccine (DOC1021) Improves Survival Compared to Standard of Care in Phase 1 Trial for Glioblastoma (Businesswire) - P1 | N=17 | NCT04552886 | "Diakonos Oncology Corp...announced today an interim analysis of the Phase 1 open label trial of DOC1021 showing substantially increased survival of glioblastoma multiforme (GBM) patients well beyond the expected median overall survival (mOS) of 12.7 months for patients receiving the standard of care (SOC). The median overall survival for the trial of newly diagnosed GBM has not yet been reached with 12-month survival among evaluable patients currently is 88%. The analysis was presented in a poster at the 2024 American Association for Cancer Research annual meeting. Twelve of 16 patients with newly diagnosed GBM remain alive with no serious adverse events attributable to DOC1021....The first GBM patient enrolled in October 2021 survived more than two years. Each of the next four patients enrolled survived more than 15 months, and two remain alive at 20.3 months and 17.5 months, despite receiving less than 25% of the projected therapeutic dose."

P1 data • Glioblastoma

Dendritic Cell Vaccination With Standard Postoperative Chemoradiation for the Treatment of Adult Glioblastoma (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: The Cooper Health System | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Diakonos Oncology Completes Phase 1 Glioblastoma Trial Recruitment; Receives FDA Orphan Drug Designation (Businesswire) - "Diakonos Oncology Corporation...announced today it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme (GBM). With the first patient enrolled in October 2021, DOC1021 has been administered to 16 patients across four dose levels. To date, DOC1021 appears to be very safe and well tolerated as there have been no attributable serious adverse events observed from DOC1021. Additionally, 13 out of 16 patients remain alive today with the vast majority of patients still progression free....Additionally, DOC1021 also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for malignant glioma, including treatment of newly diagnosed/refractory glioblastoma multiforme (GBM)."

Orphan drug • Trial status • Glioblastoma

DECIST: Th-1 Dendritic Cell Immunotherapy Plus Standard Chemotherapy for Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=43 | Recruiting | Sponsor: Baylor College of Medicine

Combination therapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4

Diakonos Oncology Awarded FDA Fast Track Designation for Innovative Dendritic Cell Vaccine for Glioblastoma (Businesswire) - "Diakonos Oncology Corporation...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s unique dendritic cell vaccine, DOC1021. The designation was based on positive preliminary safety and efficacy data from a Phase 1 clinical trial enrolling patients with glioblastoma multiforme (GBM)....The Phase 1 open-label trial of DOC1021 (NCT04552886) is underway at the MD Anderson Cancer Center at Cooper University Health Care in Camden, NJ, and at the University of Texas Health Science Center in Houston. The trial is expected to complete this year."

Fast track designation • Trial completion date • Glioblastoma

Cellipont Bioservices and Diakonos Oncology Corporation Collaborate to Develop Groundbreaking Therapy for Glioblastoma (PRNewswire) - "Cellipont Bioservices...announced today that they have entered into an agreement for the Process Development & cGMP Manufacturing of DOC1021, an autologous dendritic cell vaccine being manufactured for the treatment of glioblastoma multiforme (GBM) and other cancer indications."

Licensing / partnership • Brain Cancer • Glioblastoma • Oncology • Solid Tumor