Medikine has commenced dosing of subjects in Phase I clinical trial of an investigational biologic drug, MDK-703, in healthy participants, to potentially treat solid tumours.
MDK-703 is an extended half-life interleukin-7 (IL-7) mimetic.
This immunoglobulin Fc fragment-peptide fusion protein includes an IL-7 PEPTIKINE discovered using the platform technology of Medikine to enhance drug properties.
The trial will analyse the safety, tolerability, pharmacokinetics and pharmacodynamics of single, ascending doses of MDK-703 administered intramuscularly versus placebo.
Medikine anticipates reporting top-line data from the trial in the fourth quarter of this year.
Following the conclusion of this trial, the company intends to analyse the drug for solid tumours.
Apart from anti-tumour properties, MDK-703 cannot induce anti-drug antibodies (ADAs) that neutralise native IL-7, a problem priorly noted with IL-7 agents analysed in humans.
Furthermore, the drug showed to function similarly to IL-7 in human immune cell in vitro studies as well as in humanised mice and non-human primates in vivo studies.
MDK-703 boosted the number of memory T cells, especially T memory stem (TSCM) cells besides enhancing the total number of CD8 T and CD4 T cells, the company noted.
Medikine president and chief medical officer Dr Joseph Leveque said: “Based on preclinical data, we believe that MDK-703 has best-in-class potential, with biology consistent with facilitating the differentiation, maintenance and survival of the T cell subsets that are critical for durable anti-tumour activity in humans.
“The initial study of MDK-703 in healthy subjects is designed to provide important proof-of-pharmacology that is relevant to cancer treatment, including the impact on specific T-cell populations and the lack of neutralising IL-7 ADAs.”