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Faron Pharmaceuticals says first patient successfully been dosed in the phase I/II MATINS study of Clevegen

Published: 06:37 14 Dec 2018 EST

Cancer cells
The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies

Faron Pharmaceuticals Ltd (LON: FARN) has revealed that the first patient has successfully been dosed in phase I/II MATINS study of Clevegen, its wholly-owned novel precision cancer immunotherapy drug.

The clinical stage biopharmaceutical company pointed out that the study, being initiated at Helsinki and Oulu University Hospitals in Finland, is 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.

READ: Faron Pharmaceuticals says Phase I/II study of novel precision cancer immunotherapy drug approved by Finnish Medicines Agency

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

In pre-clinical models, inhibition of Clever-1 decreases tumour associated macrophages and myeloid-derived suppressor cells within a tumour and activates tumour-killing CD8+ cells leading to robust anti-tumour activity.

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

The initial dosing level in the study is 0.3mg/kg increasing to 1mg/kg, 3 mg/kg and 10mg/kg, with the intention 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.

Faron also noted that its scientific network has also informed the company that Clever-1 presence in glioblastoma patients with very few treatment options associates with poor survival

The company said, therefore, it intends to file a separate protocol to study these cancer patients suffering from these aggressive brain tumours.

Dr Markku Jalkanen, Faron’s chief executive officer commented: "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.”

He added: “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 USA."

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