Immune-Onc Therapeutics is set to commence the Phase I clinical trial of its IO-202 for the treatment of advanced solid tumours.

An inhibitor of the myeloid checkpoint, IO-202 is an antibody that acts on the leukocyte immunoglobulin-like receptor B4 (LILRB4).

The move comes after the US Food and Drug Administration (FDA) granted clearance to the Investigational New Drug (IND) application submitted by the company to start the trial of IO-202.

The multicentre, dose-escalation and dose-expansion trial will have a monotherapy arm and a combination treatment arm to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of the antibody alone and along with pembrolizumab.

This will be followed by indication-specific expansion arms to receive IO-202 plus pembrolizumab at the recommended Phase II dose. 

Furthermore, to facilitate a mechanistic understanding of clinical results and inform trials in the future, several biomarkers will be evaluated, according to an announcement. 

Immune-Onc noted that the trial could also offer a chance to detect initial efficacy signals. 

Immune-Onc CEO Charlene Liao said: “The FDA clearance to begin our Phase I study for IO-202 in solid tumours is a major milestone for Immune-Onc, which represents the third IND for our pipeline and the second for IO-202. 

“IO-202 is a first-in-class myeloid checkpoint inhibitor targeting LILRB4, which may provide therapeutic benefit to multiple solid tumour types where evasion of the immune system allows disease to progress and create resistance to therapy, including to T cell checkpoint inhibitors.” 

According to preclinical data, IO-202 was demonstrated to boost dendritic cell function as well as activation of T cells in vitro and hinder the growth of tumour in a solid tumour model in vivo.

Presently, IO-202 is also being analysed in the Phase I trial to treat acute myeloid leukaemia and chronic myelomonocytic leukaemia.

In October last year, Immune-Onc dosed the first subject in the Phase I clinical trial of IO-108 to treat solid tumours.