Inimmune Doses First Cancer Patient in Phase 1 Study of INI-4001

Inimmune, a biotech firm from Missoula, Montana, has announced the initiation of a Phase 1 clinical trial of its new drug, INI-4001, aimed at treating advanced solid tumors. This milestone marks the beginning of human testing for INI-4001, which serves as a TLR7/8 agonist using a nanoparticle delivery system.

The trial is structured as an open-label, multiple-ascending dose study divided into two parts. The first part, Phase 1a, focuses on single-dose escalation to assess the drug's pharmacokinetics (PK), safety, and tolerability when used as a monotherapy. Subsequently, Phase 1b will involve patients who have shown disease progression or stable disease after three cycles of INI-4001. These patients will receive a combination of INI-4001 and either an anti-PD-1 or anti-PD-L1 immunotherapy.

Pre-clinical trials have shown promising results for INI-4001. When used both as a standalone treatment and in combination with anti-PD-1 checkpoint therapy, the drug demonstrated efficacy in various murine tumor models, including LLC, MC38, and B16F10. INI-4001 has also been found to stimulate the production of the cytokine IFNα and activate antigen-presenting cells, which subsequently results in the activation of T cells in vivo. This ability to activate the immune system makes INI-4001 a potentially valuable combination agent with checkpoint inhibitors, especially since only a minority of patients currently benefit from checkpoint inhibitor monotherapy.

Alan Joslyn, CEO of Inimmune, expressed enthusiasm about the clinical trials, stating, "The initiation of INI-4001 clinical trials is a significant milestone for our company and for oncology patients. INI-4001, whether used alone or in combination with checkpoint therapy, has the potential to offer physicians a new therapeutic option."

The trial is being conducted in Australia and is expected to conclude by the end of 2025. More details about the study can be found on clinicaltrials.gov under the identifier NCT06302426.

Inimmune Corporation specializes in the development of innovative immunotherapies, vaccines, and vaccine adjuvants. The company's mission is to leverage the human immune system to develop safe and effective treatments for various conditions, including allergies, infectious diseases, autoimmune disorders, and cancer. Inimmune operates out of the Montana Technology Enterprise Center (MonTEC) in Missoula.

This Phase 1 study represents a significant step forward for Inimmune and the potential future of cancer treatment. The promising pre-clinical data and the structured phases of the trial aim to thoroughly evaluate the effectiveness and safety of INI-4001, potentially paving the way for new cancer therapies.