ImmunoGenesis has dosed the first participant in its Phase Ia/Ib clinical trial of IMGS-001 for the treatment of relapsed or refractory advanced solid tumours.

The first patient was dosed at the University of Texas MD Anderson Cancer Center in Houston, US. 

The first-in-human, multicentre, open-label dose escalation and expansion trial will evaluate the pharmacokinetics, safety and initial anti-tumour activity of IMGS-001.

It includes adult subjects with locally advanced or metastatic solid tumours that are refractory to standard-of-care therapy. 

In the dose escalation part of the trial, ImmunoGenesis plans to include patients with tumours such as colorectal, ovarian and triple-negative breast cancer.

A lead asset of the company, IMGS-001 is a dual-specific programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 ligand 2 (PD-L2) monoclonal antibody.

The antibody has cytotoxic effector activity and is intended for treating immune-excluded cancers that are resistant to current immunotherapies.

In preclinical research, IMGS-001 was shown to offer improved response rates in head-to-head studies versus existing immunotherapies. 

In June 2023, the company received an investment of $4.5m from the Cancer Focus Fund for its Phase Ia/Ib trial of IMGS-001. 

ImmunoGenesis president and CEO James Barlow said: “Many tumours are not responsive to the current immunotherapies, representing a significant unmet need. 

“We believe that this study will deliver initial proof of concept for our groundbreaking multitasking approach of using a single molecule to address immunosuppression and PD-1 pathway blockade.”