HOUSTON, Dec. 10, 2025 — Diakonos Oncology Corp. announced it has been awarded a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT) valued at more than $7 million. Diakonos was one of nine awardees selected from 164 applicants to support advancing DOC1021 into a Phase 1/2 clinical trial for patients with refractory melanoma.
Jay Hartenbach, President and COO of Diakonos Oncology, said the CPRIT award will enable the company to evaluate DOC1021 in a critically underserved indication. The company’s personalized dendritic cell vaccine platform has shown immune activation and efficacy across multiple preclinical tumor models and clinical indications, he said.
Melanoma is an aggressive skin cancer that can become refractory when it no longer responds to immune checkpoint inhibitors or targeted therapies, leaving patients with limited options and poor outcomes. The planned Phase 1/2 study will assess the safety and preliminary efficacy of DOC1021 in refractory melanoma patients and will include circulating tumor DNA (ctDNA) and immune biomarker analyses.
Ryan J. Sullivan, MD, Director of the Cutaneous Medical Oncology Program at Massachusetts General Brigham Cancer Institute, said DOC1021’s personalized dendritic cell approach—presenting a patient’s tumor antigens in a viral-mimicking context—offers a novel way to re-engage the immune system against tumors that have escaped standard therapies. The trial will test whether that biology can translate into clinical benefit for high-risk patients.
Enrollment in the Phase 1 portion of the refractory melanoma study is expected to begin in January 2026.
DOC1021 is a patient-derived, double-loaded dendritic cell therapy that combines tumor lysate and amplified tumor-derived mRNA. The double-loading approach mimics viral infection to provoke a robust TH1 tumor-killing response by sourcing antigens from both protein and RNA, and it targets the full antigen repertoire of a patient’s tumor. Manufacturing does not require genetic modification of immune cells, and administration does not require preconditioning chemotherapy or high-dose IL-2, allowing outpatient delivery and broader community access.
Diakonos currently has two active clinical trials of its platform: a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma study (NCT06805305). The company received FDA Fast Track designations for the glioblastoma program in October 2023 and for the pancreatic cancer program in May 2024, and an Orphan Drug Designation for glioblastoma in January 2024. The refractory melanoma Phase 1/2 study will be initiated with support from CPRIT.
Diakonos Oncology Corp., based in Houston, is a clinical-stage biotechnology company developing a double-loaded, patient-derived dendritic cell therapeutic platform to address unmet needs in late-stage and aggressive cancers. More information is available at https://www.diakonosoncology.com
Media contacts:
David Schull, Russo Partners, 858-717-2310, [email protected]
Jay Hartenbach, Diakonos Oncology, [email protected]
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