Green light for ImmunOs Therapeutics first clinical trial

ImmunOs Therapeutics, a biopharmaceutical company leveraging its HLA-based technology platform to develop first-in-class therapeutics for treating cancer and autoimmune diseases, has received regulatory approval to conduct clinical studies for lead candidate IOS-1002. The first patients will be enrolled in Q1 2023.

The Zurich-based startup has identified specific HLA molecules known to activate the immune system and is utilizing these HLA molecules as the backbone of novel therapies capable of stimulating both the innate and the adaptive immune systems of cancer patients to eliminate tumour cells. ImmunOs’ lead program, IOS-1002, is a first-in-class, multi-functional agent based on a naturally occurring human leukocyte antigen (HLA) that targets multiple immune checkpoints to activate innate and adaptive immune cells, thereby leading to profound anti-tumour activity.

According to Christoph Renner, Chief Medical Officer of ImmunOs, preclinical trials showed the ability of IOS-1002 to bind to three different immune checkpoint targets, LILRB1 (ILT2), LILRB2 (ILT4) and KIR3DL1, leading to significantly increased anti-tumour responses of human macrophages, T cells, and NK cells.

With full ethical institutional approval from the Human Research Ethics Committee (HREC) and regulatory approval from the Therapeutic Goods Administration (TGA), the company can initiate its Phase 1 trial of IOS-1002. Planned to take place n Australia, the trial is expected to enrol up to 140 patients, with the first ones expected to be enrolled in Q1, 2023.

The primary endpoints of Phase 1, open-label, non-randomized, multicenter, dose-escalation cohort expansion study, will be the safety and tolerability of the compound, while secondary endpoints include efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of IOS-1002. In the trial, the compound will be administered at various dose levels to patients with advanced solid tumours either as monotherapy or in combination with a PD-1 monoclonal antibody.

"Advancing our lead compound IOS-1002 into a first-in-human trial is a major milestone for our team and provides a potential new option for patients," said Sean R. Smith, CEO of ImmunOs Therapeutics. "Our goal is not only to determine the safety, tolerability and activity of IOS-1002 but also to assess its clinical potential as both monotherapy and in combination with anti-PD-1 therapy, as supported by preclinical data."

(Press release/RAN)