The trial is designed to assess immunotherapeutic agent for treating patients with advanced solid tumours. Credit: CI Photos / Shutterstock.

Inimmune has dosed the first subject in its Phase I clinical trial of INI-4001, an immunotherapeutic agent designed for treating patients with advanced solid tumours.

INI-4001 is a TLR7/8 agonist in a nanoparticle delivery system.

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The first-in-human, open-label, multiple-ascending dose, two-part dose-ranging and cohort expansion study will comprise two parts.

The initial phase of the trial, Phase Ia, will have single-dose escalation cohorts to assess the pharmacokinetics, safety, and tolerability of INI-4001 as a monotherapy.

Following the single dose assessments, the trial will progress to Phase Ib.

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In this phase, patients who have either stable disease or have progressed after three cycles of INI-4001 will be eligible for concurrent treatment with anti-PD-1 or anti-PD-L1 immunotherapy in addition to INI-4001.

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Pre-clinical studies have shown promise for INI-4001, demonstrating efficacy both as a standalone treatment and when combined with anti-PD-1 checkpoint therapy in syngeneic murine tumour models such as LLC, MC38, and B16F10.

Furthermore, INI-4001 has been observed to stimulate the production of cytokine IFNα and activate antigen-presenting cells, which are crucial for T cell activation in vivo.

The trial is underway in Australia and is anticipated to conclude by the end of next year.

Inimmune CEO Alan Joslyn said: “We are very excited that INI-4001 clinical trials have commenced, as this marks an important milestone for our company and oncology patients.

“INI-4001, either as monotherapy or in combination with checkpoint therapy, can potentially provide physicians a new therapeutic option in their treatment toolbox.”

In August last year, Inimmune dosed the first subject in a randomised, placebo-controlled Phase I/Ib study of INI-2004 to treat allergic rhinitis.