UK-based MiNA Therapeutics has started the Phase I clinical trial (TIMEPOINT) of MTL-CEBPA for the treatment of patients suffering with advanced solid tumours.

TIMEPOINT is a global Phase I/Ib clinical trial is designed to assess the safety and tolerability of MTL-CEBPA, an saRNA restoring the expression of C/EBP-a, in patients with advanced solid tumour.

The clinical study is being conducted in combination with anti-PD1 checkpoint inhibitor pembrolizumab in these patients.

The MTL-CEBPA is composed of a double-stranded RNA formulated into a SMARTICLES liposomal nanoparticle, and is intended to activate the CEBPA gene, which encodes the CCAAT / enhancer binding protein alpha (C/EBP-a).

MiNA Therapeutics noted that the drug is also being investigated in an ongoing multi-centre Phase Ib study in patients suffering with advanced liver cancer and is being conducted in combination with sorafenib.

MiNA Therapeutics CEO Robert Habib said: “Initiation of the Phase I TIMEPOINT clinical trial emphasises the continued exploration of MTL-CEBPA, the first drug candidate that targets C/EBP-α, a master regulator of immune cells that play a critical role in tumour resistance.

“We are excited to take the next step and test MTL‑CEBPA in additional cancer populations in a potentially synergistic combination with an anti-PD1 checkpoint inhibitor.”

According to the company, the TIMEPOINT trial comprises a dose-escalation followed by a dose expansion.

MTL‑CEBPA will be administered as an intravenous infusion once a week for three weeks, followed by one week of rest between each cycle.

The pre-clinical studies of the drug candidate have demonstrated that the anti-tumour activity of anti-PD1 checkpoint inhibition has been shown to reduce immune suppression from dysregulated myeloid cells.

In June 2016, MiNA Therapeutics started the Phase I human clinical study (OUTREACH) of MTL-CEBPA for the treatment of patients with advanced liver cancer.