On May 30, 2025 Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, reported the closing of a $20 million private placement of Simple Agreements for Future Equity (SAFE) to accelerate the company’s Phase 2 glioblastoma trial for dubodencel, also known as DOC1021, and support the expansion of its clinical portfolio to other indications, including refractory melanoma (Press release, Diakonos Oncology, MAY 30, 2025, View Source [SID1234653531]). The financing includes backing by new investors Baylor College of Medicine (BCM), the Brain Tumor Investment Fund (BTIF), and the Buttonwood Titan QC Fund, with additional participation from existing shareholders including CEO Mike Wicks, MS. BCM is also contributing in-kind services toward the company’s pre-clinical and clinical development programs. This $20 million financing follows Diakonos’ oversubscribed $11.4 million seed financing that closed last year and serves as a bridge to a Series A financing that the company plans to launch in the second half of this year.
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"With our Phase 2 glioblastoma trial underway at leading treatment centers across the U.S., the financing comes at a critical inflection point as we begin defining the path toward commercialization," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Early clinical results in both glioblastoma and pancreatic cancer continue to exceed expectations, and when viewed alongside our data from a range of preclinical models, we are increasingly optimistic that this patient-derived immunotherapy holds potential for additional indications with high unmet need."
John Higgins, Managing Director at the Brain Tumor Investment Fund, added, "The promising Phase 1 data for dubodencel in glioblastoma were a strong motivator for us to help fund the Phase 2 trial, and we are pleased that our investment will serve as a catalyst for additional fundraising as the company advances the glioblastoma program and expands its clinical pipeline."
Joseph Petrosino, Ph.D., Chief Scientific Innovation Officer of Baylor College of Medicine, said, "At BCM, we are eager to propel our latest discoveries to the bedside, particularly for new therapies targeting glioblastoma and pancreatic cancer, where patients are in desperate need for better options. We are proud to work with Diakonos to accelerate these exciting early clinical results, and we are eager to support Diakonos as it builds on encouraging pre-clinical data suggesting dubodencel may be more broadly successful for the treatment of other difficult cancers and diseases."
Joseph Gunnar & Co. LLC served as placement agent for Diakonos in the SAFE offering. A SAFE is a non-debt instrument where an investor provides funding and receives the right to convert the investment into equity shares at a later date upon the occurrence of specified events, typically when a company raises a qualified equity financing round or experiences a liquidity event.
About Dubodencel
Dubodencel, also known as DOC1021, is a first-in-class, double-loaded autologous 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 it does not require preconditioning of bone marrow or high dose IL-2 for administration. Dubodencel allows for a simple administration in the outpatient setting and broad reach via community cancer centers.
In addition to the recently opened Phase 2 glioblastoma study, a clinical trial of Diakonos’ dubodencel is ongoing for the treatment of pancreatic cancer. Diakonos received Fast Track designations from the FDA for both the glioblastoma and pancreatic cancer programs in October 2023 and May 2024, respectively. The company received Orphan Drug Designation for the glioblastoma program in January 2024.