Diakonos Oncology DOC1021 Clears Safety Review, Presents Data at Major Cancer Conferences

Diakonos Oncology Corp., a clinical-stage biotechnology company developing a new generation of immunotherapies to treat challenging and aggressive cancers, announced that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing Phase 2 DOC-GBM2 clinical trial of DOC1021 in patients with newly diagnosed glioblastoma (GBM) has completed a scheduled safety review and recommended that the study continue as planned. The DSMB's recommendation followed a review of available safety data from patients randomized in the DOC-GBM2 study.

Approximately six months after the first patient was treated, the committee reported that no safety concerns have been identified to date and that no changes to the study design are warranted. The Chief Medical Officer stated that it is reassuring to see a safety profile for DOC1021 in this study that is consistent with prior Phase 1 data, and the independent committee's recommendation to continue this Phase 2 trial without modification provides added confidence as the company progresses the development of DOC1021 for patients with glioblastoma.

The Company will present new clinical trial data at the American Association for Cancer Research (AACR) Annual Meeting, to be held April 17-22 in San Diego, California, and at the American Academy of Neurology (AAN) Annual Meeting, to be held April 18-22 in Chicago, Illinois. Both conferences will feature clinical data on DOC1021 (dubodencel), a first-in-class, patient-derived double-loaded dendritic cell investigational therapy, with AACR focusing on pancreatic ductal adenocarcinoma and AAN on glioblastoma.

The AACR poster presentation is titled "Clinical and Immunologic Assessment of DOC1021 Dendritic Cell Therapy in Resectable or Borderline Resectable Pancreatic Cancer" (abstract #CT093 / poster #24 in Poster Section 51) and will be presented Monday, April 20, from 9:00 AM–12:00 PM PT. The AAN poster presentation is titled "DOC1021 Cell-based Immunotherapy in Combination with Standard Chemoradiation for Adjuvant Therapy of Glioblastoma: Early Results from an Expanded Access Protocol of a Phase I Trial" (abstract #3099 / poster #010 in Neighborhood 6) and will be presented Wednesday, April 22, from 11:45 AM–12:45 PM CT.

The President and COO stated that presenting data at both of these conferences underscores the breadth and potential impact of DOC1021 across some of the most challenging cancers. The AACR presentation provides updated data from the ongoing pancreatic cancer study, and the AAN presentation will mark the first report of results from the expanded access program in glioblastoma. These clinical data continue to validate DOC1021's novel mechanism, which leverages a patient's full complement of tumor antigens to drive robust immune responses against malignancy.

DOC1021 is a first-in-class, patient-derived double-loaded dendritic cell therapy that 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.

The approach does not require any molecular modification or genetic engineering of the patient's immune cells and does not require preconditioning chemotherapy or high dose IL-2 for administration. DOC1021 is designed for outpatient administration and broad access via community cancer centers.

Diakonos currently has two actively enrolling clinical trials with DOC1021, a Phase 1 pancreatic cancer study (NCT04157127) and a Phase 2 glioblastoma (GBM) study (NCT06805305). Diakonos received Fast Track designation 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. A refractory melanoma Phase 1/2 study with DOC1021 (NCT07288112) will be initiated early this year with the facilitation and support of the Cancer Prevention and Research Institute of Texas (CPRIT).

Based in Houston, TX, 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.