Immunomic Therapeutics has dosed the first patient in a first-in-human Phase I clinical trial using ITI-1001, a plasmid DNA (pDNA) vaccine, to treat glioblastoma multiforme (GBM), a rare form of brain cancer.
Led by Center for Neuro-Oncology clinical director Dr David Reardon, the open-label, single-centre study is being carried out at the Dana-Farber Cancer Institute in Boston, Massachusetts.
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It will assess the immunogenicity, tolerability, safety and preliminary efficacy of ITI-1001 in newly diagnosed patients with GBM.
Nearly ten participants will receive 8mg ITI-1001 vaccine through intra-muscular injection for nearly 24 months excluding screening and surgery.
During the four-six weeks period, two priming vaccinations will be given between definitive surgical resection and SOC chemoradiation initiation.
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As per the schedule of assessments, patients will then be followed by two post-chemoradiation priming vaccinations and five ITI-1001 vaccine boosters given in parallel with maintenance TMZ.
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By GlobalDataThe primary outcome measures include a number of participants with dose-limiting toxicities and a number of occurring adverse events.
Immunomic Therapeutics chief scientific officer Dr Teri Heiland said: “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”
ITI-1001 uses the UNITE platform that leverages lysosomal-associated membrane protein for producing antibodies, inflammatory cytokines, and immunological memory cells.
It mainly targets the pp65, IE-1 and gB viral antigens of cytomegalovirus expressed in GBM, but not in normal brain cells.
