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.
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.
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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The 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.