Regulators give green light to first-in-human study with MDX-124

12 December 2022

Medannex today received formal approval to commence dosing patients in the first-in-human study with monoclonal antibody therapy MDX-124.

The Phase Ib/II oncology study was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and the Ethics Committee.

Medannex will now work the Chief Investigator to finalise documentation at the University of Liverpool’s Clinical Trials Unit and begin consenting patients for the study.

The study’s modular design will allow flexibility and quick read-outs, as well as enabling the fast addition of MDX-124 to established cancer therapies.

Once the Phase II dose is established, MDX-124 will proceed straight to a frontline setting in key tumour types. This is very rare for a new investigational therapy and is driven by compelling non-clinical data.

In parallel with the clinical study, Medannex is developing a companion diagnostic program to identify the patients most likely to benefit from MDX-124.

In preclinical studies, MDX-124 was shown to induce cancer cell cycle arrest, significantly inhibit the migration which leads to metastatic spread and harness the immune system to attack cancer cells via antibody-dependent cell-mediated cytotoxicity. Furthermore, MDX-124 has demonstrated promising synergistic activity with a range of existing cancer treatments.