Diakonos Oncology’s mRNA-Loaded DOC1021 Shows Promising Phase I Glioblastoma Results, Advances to Phase II
HOUSTON – June 2, 2025 – Diakonos Oncology Corp., a clinical-stage biotechnology company, today announced positive Phase I clinical trial results for Dubodencel (DOC1021), a novel patient-derived mRNA-loaded dendritic cell therapy for glioblastoma (GBM). The trial demonstrated a favorable safety profile and early signs of clinical activity, supporting its rapid advancement to a randomized Phase II trial.
“This milestone is a significant advance for both Diakonos Oncology and for glioblastoma patients urgently needing better treatment options,” said Jay Hartenbach, President and COO.
The study showed an 88% 12-month overall survival (OS) rate, significantly higher than the ~60% expected with standard care for this challenging patient population (94% MGMT unmethylated). Data also indicated a robust immune response and provided insights into pseudo-progression, where early imaging changes represent immune activity rather than tumor growth.
Dubodencel, a first-in-class, double-loaded autologous dendritic cell therapy, uniquely combines tumor lysate and amplified tumor-derived mRNA to generate a potent anti-tumor immune response without needing complex cell modifications or preconditioning.
Diakonos recently completed a $20 million financing round to support the accelerated Phase II GBM program and broader cancer indications. The therapy holds FDA Fast Track designations for both GBM and pancreatic cancer, and Orphan Drug Designation for GBM.
Source:
https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-phase-i-results-of-dubodencel-doc1021-for-the-treatment-of-glioblastoma-at-the-asco-2025-annual-meeting-302469896.html
About PackGene
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
