Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma

HOUSTON, May 6, 2026 /PRNewswire/ -- Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021, the Company's first-in-class, patient-derived double-loaded dendritic cell investigational therapy, for the treatment of unresectable or metastatic cutaneous melanoma.

Unresectable or metastatic cutaneous melanoma represents an advanced form of skin cancer in which the disease cannot be removed surgically or has spread to distant organs. While advances in targeted therapies and immune checkpoint inhibitors have improved outcomes for some patients, many individuals experience disease progression, limited durability of response, or treatment‑related toxicity, underscoring the continued need for novel therapeutic approaches that can generate durable anti‑tumor immune responses.

"Receiving Fast Track designation underscores the FDA's recognition of the significant unmet need that remains for patients with advanced melanoma and the potential of DOC1021 to address this challenge," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "This designation supports our ongoing clinical development efforts and reflects the promise of DOC1021's novel approach, which leverages a patient's full complement of tumor antigens to drive meaningful anti-tumor immune responses."

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. The Company remains focused on generating robust clinical data to further validate its platform and expand treatment options for patients with advanced cancers.

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.

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

Media Contact:
David Schull
Russo Partners
858-717-2310
[email protected]

Jay Hartenbach
Diakonos Oncology
[email protected]

SOURCE Diakonos Oncology