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.

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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.”