- CPRIT award exceeds $7 million, with Diakonos selected as one of only nine awardees from a pool of 164 applicants
- Funding will support advancing DOC1021 into a Phase 1/2 clinical trial for patients with refractory melanoma
HOUSTON, Dec. 10, 2025 /PRNewswire/ -- Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, today announced that the Company was selected for a Product Development Research Grant through The Cancer Prevention and Research Institute of Texas (CPRIT), an award valued at more than $7 million. The Company was selected for funding as one of nine awardees out of 164 applicants for its proposal titled 'Advancing DOC1021: Phase 1/2 Refractory Melanoma Study,' which aims to expand DOC1021 into early-stage clinical development in a third target indication.
"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. "Across more than two dozen preclinical tumor models and multiple clinical indications, our personalized dendritic cell vaccine platform has shown a consistent pattern of potent immune activation and efficacy. With CPRIT's support, we are now able to evaluate whether these same immune mechanisms can also benefit patients with refractory melanoma, a population with significant unmet medical need."
Melanoma is a serious and often aggressive form of skin cancer that arises from melanocytes, the pigment-producing cells in the skin. While many cases can be treated effectively when detected early, some patients experience disease progression despite available therapies such as immune checkpoint inhibitors or targeted therapies. In the case of refractory melanoma, the disease no longer responds to immune checkpoint inhibitors, resulting in limited options and poor clinical outcomes. Diakonos' planned Phase 1/2 study will evaluate the safety and preliminary efficacy of DOC1021, along with ctDNA and immune biomarker responses, in this particularly high-need patient population.
"Despite the remarkable progress made with targeted therapies and immune checkpoint inhibitors, patients with refractory melanoma still have very limited options," said Ryan J. Sullivan, MD, Director of the Cutaneous Medical Oncology Program at Massachusetts General Brigham Cancer Institute. "DOC1021's personalized dendritic cell approach, which presents each patient's own tumor antigens in a viral-mimicking context, offers a compelling new way to re-engage the immune system against tumors that have escaped standard therapies. This trial will allow us to rigorously evaluate whether that biology can translate into meaningful benefit for this high-risk patient population."
Enrollment in the Phase 1 clinical study of DOC1021 for patients with refractory melanoma is expected to begin in January 2026, representing an important step forward in the Company's efforts to advance this investigational therapy into early-stage clinical development.
About DOC1021
DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that uniquely 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, which mimics a viral infection, unlocks a synergistic and exponentially more powerful tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient's immune cells for manufacturing and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 allows for simple administration in the outpatient setting and broad reach via community cancer centers.
Diakonos currently has two active clinical trials with DOC102, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs, in October 2023 and May 2024, respectively. The company also received Orphan Drug Designation for the GBM program in January 2024. The refractory melanoma Phase 1/2 study with DOC1021 will be initiated with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).
About Diakonos Oncology Corp.
Based in Houston, 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, focused on addressing the critical, unmet medical needs for treatment of late-stage and aggressive cancers. For more information visit: https://www.diakonosoncology.com
Media Contact:
David Schull
Russo Partners
858-717-2310
david.schull@russopartnersllc.com
Jay Hartenbach
Diakonos Oncology
pr@diakonosoncology.com
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SOURCE Diakonos Oncology
