FDA Grants Fast Track Designation to DOC1021 for Cutaneous Melanoma

The FDA granted fast track designation (FTD) to DOC1021 (dubodencel), a first-in-class patient-derived double-loaded dendritic cell therapy, for the treatment of unresectable or metastatic cutaneous melanoma, according to a news release.¹ The designation is the third FTD status granted to DOC1021, which has previously received the designation for pancreatic cancer and glioblastoma (GBM).

“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,” Jay Hartenbach, president and CEO of Diakonos Oncology, stated in the news release.

Mechanism of Action and Administration

DOC1021 is manufactured from a patient’s own dendritic cells combined with tumor lysate and amplified tumor-derived mRNA prepared from freshly obtained patient tumor specimens. The company describes this dual-loading strategy as a physiologic mimic of viral infection designed to activate a synergistic antitumor immune response targeting the complete cancer antigen pool. Unlike other cell therapies, DOC1021 does not require molecular modification of immune cells, preconditioning regimen, or high-dose interleukin-2, and can be given with outpatient administration to enable broad clinical access.

Phase 1/2 Melanoma Trial Design

The FTD supports the investigation of DOC1021 in ongoing and planned studies, including a phase 1/2 open-label single-arm trial (NCT07288112) of patients with melanoma refractory to at least 1 prior therapy including anti–PD-1.² This trial is currently recruiting at the University of Alabama at Birmingham and City of Hope in Duarte, California with an estimated enrollment of 35 patients. The trial combines DOC1021 with peginterferon alfa-2a (pIFN; Pegasys). All participants will undergo filgrastim (Neupogen) mobilization followed by leukapheresis, then receive 2 image-guided perinodal DOC1021 injections 2 weeks apart with concurrent weekly subcutaneous pIFN for 4 doses. An optional booster injection of DOC1021 with additional pIFN is offered approximately 6 months after the first dose. Optional concurrent treatment with anti–PD-1 agents is also permitted during follow-up visits.

The phase 1 component will evaluate dose-limiting toxicities through 6 weeks after the first DOC1021 dose. The phase 2 component will assess objective response rate, defined as confirmed complete or partial response by RECIST1.1 criteria, as the primary efficacy end point over 5 years. Secondary end points include overall survival, duration of response, progression-free survival, disease control rate, and adverse events by CTCAE v5.0. Exploratory end points include circulating tumor DNA kinetics and health-related quality of life. Primary completion is estimated for January 2031, with study completion estimated for January 2033.

Eligible patients must be 18 years or older with an ECOG performance status of 0 or 1, have at least 1 lesion available for biopsy or resection yielding a minimum of 50 mg of tumor material, and have at least 1 measurable target lesion evaluable after DOC1021 by RECIST 1.1. Stable brain metastases after prior treatment are permitted.

Broader Development Program and Early Results

Diakonos currently has 3 actively enrolling trials evaluating DOC1021, including a phase 1 pancreatic cancer study (NCT04157127) and a phase 2 GBM study (NCT06805305), in addition to the melanoma trial. DOC1021 received FDA orphan drug designation for the GBM program in January 2024.

Recently presented clinical data from the other 2 trials was favorable.³ Patients with resected pancreatic cancer received DOC1021 after adjuvant chemotherapy; 5 of 7 remained alive with survival durations from 20 to 56 months. In the glioblastoma trial, patients received surgical resection and chemoradiotherapy before DOC1021 injections and interferon; all exceeded 12 months of overall survival. Grade 1 and 2 flu-like symptoms were observed in the pancreatic cancer trial, whereas the most common adverse events in the glioblastoma trial were mild injection site reactions.

REFERENCES

1. Diakonos oncology awarded fast track designation by FDA for DOC1021 (dubodencel) in unresectable or metastatic cutaneous melanoma. News release. Diakonos Oncology. May 6, 2026. Accessed May 7, 2026. https://tinyurl.com/5y7wmcfj

2. DOC1021 Dendritic cell immunotherapy for refractory melanoma. ClinicalTrials.gov. Updated April 14, 2026. Accessed May 7, 2026. https://clinicaltrials.gov/study/NCT07288112

3. Diakonos Oncology reports positive clinical data from phase 1 pancreatic cancer study and expanded access program in glioblastoma at AACR and AAN 2026. News release. Diakonos Oncology. May 1, 2026. Accessed May 7, 2026. https://tinyurl.com/yy57evvu