Dosing begins in Faron's study of 'Clevegen' drug

Clinical stage biopharmaceutical company Faron Pharmaceuticals announced on Friday that the first patient has successfully been dosed in the phase I/II MATINS study of Clevegen, its wholly-owned novel precision cancer immunotherapy drug.

The AIM-traded firm said the study, being initiated at Helsinki and Oulu University Hospitals in Finland, was a first-in-human open label phase I/II clinical trial to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours.

It described Clevegen as a novel anti-Clever-1 antibody, which caused changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages.

Clever-1, a cell surface receptor expressed mainly by tumour vasculature and monocytes/macrophages, had been shown to promote tumour growth, to control cell-mediated immunity, and to participate in the control of B cell response and antibody production, Faron claimed.

In pre-clinical models, inhibition of Clever-1 decreased tumour-associated macrophages and myeloid-derived suppressor cells within the tumour, and activated tumour-killing CD8+ cells, leading to what the company called “robust” anti-tumour activity.

The treatment, if successful, could ultimately be used as a standalone therapy or in combination with other immunotherapies such as PD-1/PD-L1 inhibitors.

Faron said the initial dosing level in the study was 0.3mg/kg, increasing to 1mg/kg, 3 mg/kg and 10mg/kg.

The intention was to reach the maximum 10mg/kg dosing level during the first half of 2019, and to study Clever-1 occupancy in circulating monocytes from bone marrow to tumour.

Breaking down that migration and converting the monocytes from an immune-suppressive to immune-activating phenotype were the main goals of the first part of the study, together with tolerability and safety observations.

Faron said its scientific network had also informed it that Clever-1 presence in glioblastoma patients with very few treatment options was associated with poor survival.

The company therefore intended to file a separate protocol to study those cancer patients suffering from such “aggressive” brain tumours.

“We are delighted that Clevegen has advanced into the clinic,” said Faron chief executive officer Dr Markku Jalkanen.

“We have already seen promising pre-clinical and ex-vivo human data, and so this is a significant step in helping us to further understand the potential of this novel therapy.

“We are pleased to have achieved such rapid progress with our Clevegen programme so far and look forward to the opening of further trial sites and the expansion of the study in Europe and US.”