Diakonos Oncology Corp. has been awarded a Product Development Research Grant from the Cancer Prevention and Research Institute of Texas (CPRIT) valued at more than $7 million to advance DOC1021 into a Phase 1/2 clinical trial for patients with refractory melanoma. The company was one of nine awardees selected from a pool of 164 applicants.
The funding will support the study “Advancing DOC1021: Phase 1/2 Refractory Melanoma Study,” which will evaluate the safety and preliminary efficacy of DOC1021 alongside circulating tumor DNA (ctDNA) and immune biomarker assessments in patients whose melanoma no longer responds to immune checkpoint inhibitors.
“We are honored to have CPRIT’s support as we bring DOC1021 into a new and critically underserved indication,” said Jay Hartenbach, president and COO of Diakonos Oncology. He noted that the company’s personalized dendritic cell vaccine platform has demonstrated potent immune activation and efficacy across multiple preclinical tumor models and clinical indications.
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 each patient’s tumor antigens in a viral-mimicking context—offers a new strategy to re-engage the immune system against tumors that have escaped standard therapies.
Enrollment for 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 prepared from freshly obtained patient tumor specimens. The dual loading approach aims to mimic a viral infection and elicit a robust TH1 immune response by delivering both protein and RNA antigens. The therapy does not require molecular modification of patient immune cells, preconditioning chemotherapy, or high-dose interleukin-2, and is designed for outpatient administration across community cancer centers.
Diakonos currently sponsors two active clinical trials of the DOC102 platform: a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma study (NCT06805305). The Food and Drug Administration has granted Fast Track designations for both the glioblastoma and pancreatic cancer programs (October 2023 and May 2024, respectively), and the glioblastoma program received Orphan Drug Designation in January 2024.
Based in Houston, Diakonos Oncology is a clinical-stage biotechnology company focused on developing patient-derived dendritic cell therapies for late-stage and aggressive cancers. For more information, visit 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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