Diakonos Oncology Announces First Patients Dosed in Phase 1/2 DOC-RM Study of DOC1021 in Refractory Melanoma

• First patients dosed at City of Hope and the University of Alabama at Birmingham
• DOC-RM recently featured as a Trial-in-Progress presentation at the 2026 ASCO Annual Meeting
• FDA Fast Track designation granted for unresectable or metastatic cutaneous melanoma
• Outpatient treatment approach without lymphodepleting chemotherapy or high-dose IL-2
• Initial safety, biomarker and clinical activity results anticipated in Q4 2026
  

HOUSTON, July 30, 2026 (GLOBE NEWSWIRE) -- Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced that the first patients have been dosed in DOC-RM, its Phase 1/2 clinical study evaluating DOC1021 (dubodencel) in patients with refractory melanoma, at City of Hope in Duarte, California, and the University of Alabama at Birmingham (UAB).

This milestone follows the presentation of DOC-RM as a trial-in-progress abstract at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and represents the transition of the program into active clinical evaluation.

"Roughly half of melanoma patients progress after checkpoint inhibition, and the options that follow are defined as much by their toxicity and cost as by their benefit," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "We are encouraged that the first patients have received DOC1021 treatment with no significant acute adverse events, consistent with our glioblastoma and pancreatic trials. We look forward to reporting initial preliminary results from DOC-RM by the end of the year.”

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. Patients receive two courses of DOC1021 in combination with pegylated interferon and an optional booster dose approximately six months later. Primary and secondary endpoints include safety, objective response, circulating tumor DNA (ctDNA), and immune biomarkers measured in tumor and peripheral blood.

“Patients whose melanoma progresses following anti-PD-1 therapy continue to face limited treatment options, highlighting the need for new immunotherapeutic strategies," said Yan Xing, MD, PhD, Associate Professor in the Department of Medical Oncology & Therapeutics Research and Principal Investigator at City of Hope. "DOC1021 is designed to utilize each patient's own tumor antigens to generate an individualized immune response. We’re excited to evaluate this investigational approach and contribute to the clinical development of DOC1021.”

“The design of this trial offers the opportunity to study an investigational dendritic cell immunotherapy without the need for preconditioning chemotherapy or high-dose IL-2," said John Dubay, MD, Assistant Professor in the Department of Medicine, Division of Hematology and Oncology, and Principal Investigator at the University of Alabama at Birmingham. "The ability to administer DOC1021 in an outpatient setting may also help streamline treatment delivery and broaden patient access. We’re pleased to begin treating patients and participating in this important study.”

DOC-RM is currently enrolling patients at City of Hope, the University of Alabama at Birmingham, Massachusetts General Hospital, Banner MD Anderson Cancer Center, UT Southwestern, HonorHealth Research Institute, University of North Carolina, and Atlantic Health. The trial is supported by Diakonos Oncology and a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT).

The study builds on preclinical data demonstrating antitumor activity across multiple tumor models, including B16F10 melanoma. DOC1021 received FDA Fast Track designation for unresectable or metastatic cutaneous melanoma in May 2026.

About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy designed to generate a broad, personalized anti-tumor immune response. The therapy combines tumor lysate and amplified tumor-derived mRNA prepared from each patient's tumor with autologous dendritic cells, enabling presentation of the full spectrum of tumor antigens.

The proprietary double-loading approach mimics the natural immune activation that occurs during viral infection, unlocking a synergistic and robust multi-antigen immune response while targeting the complete repertoire of the cancer antigen pool. Unlike many cell therapies, DOC1021 does not require any molecular modification or genetic engineering of immune cells, lymphodepleting chemotherapy, or high-dose IL-2 for administration, allowing for outpatient administration and broad access through community cancer centers.

Diakonos is currently evaluating DOC1021 in three actively enrolling clinical trials: a Phase 1 pancreatic cancer (NCT04157127), a Phase 2 in glioblastoma (GBM) (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. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.

About Diakonos Oncology Corp.
Based in Houston, TX, 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. The company is focused on addressing critical, unmet medical needs in late-stage, aggressive, and lethal cancers. For more information visit: https://www.diakonosoncology.com

Investor & Media Contacts:
Daniel Ferry
LifeSci Advisors
617-430-7576
daniel@lifesciadvisors.com

Jay Hartenbach
Diakonos Oncology
pr@diakonosoncology.com

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