Diakonos Oncology has dosed the first subject in its Phase II trial of investigational patient-derived double-loaded dendritic cell therapy, DOC1021, for treating a highly aggressive brain tumour, glioblastoma (GBM).
The dosing procedures took place at the City of Hope in California, US.
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The trial aims to assess the tolerability, efficacy, and safety of the therapy in conjunction with the standard-of-care treatment (SOC) compared to SOC alone in the adult population newly diagnosed with GBM (IDH-wildtype).
It is set to open at around 20 US centres, including Atlantic Health System and UTHealth Houston.
Diakonos Oncology chief medical officer Dr Laura Aguilar said: “We are tremendously proud to announce the dosing of the first patient in this critical Phase II study, marking an important milestone in our mission to develop a much-needed treatment for patients with glioblastoma, a disease that, despite significant advances in neuro-oncology, remains one of the most challenging cancers to treat, with patient outcomes still falling short of expectations.
“This Phase II trial represents an important step in evaluating DOC1021’s potential to enhance the immune response and work alongside standard therapies.”
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By GlobalDataAs the trial progresses, Diakonos Oncology continues its research with DOC1021, also exploring its potential in treating pancreatic cancer.
According to the company, the therapy combines tumour lysate and amplified tumour-derived messenger ribonucleic acid (mRNA). It is created by fusing a patient’s own dendritic cells with mRNA and proteins that are extracted from the freshly collected tumour samples of the patients.
This technique stimulates a tumour-killing TH1 immune response and does not need molecular modification of immune cells, preconditioning chemotherapy, or high-dose IL-2, allowing for administration.
The company has secured the Food and Drug Administration (FDA) fast track designations for its GBM, as well as pancreatic cancer programmes, in October 2023 and May 2024, respectively.
Additionally, DOC1021 received orphan drug status for the GBM programme in January 2024.
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