LONDON (ShareCast) - (Sharecast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals announced on Monday that its clinical trial application to conduct a Phase I/II study with 'Clevegen', its wholly-owned novel precision cancer immunotherapy drug in development for the treatment of selected metastatic or inoperable tumours, has been approved by the Finnish Medicines Agency (FIMEA).
The AIM-traded firm said patient recruitment into the Phase I/II 'MATINS' study was expected to begin shortly at Helsinki and Oulu University Hospitals in Finland.

It said the same clinical trial application was also under review by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the Royal Marsden Hospital in London and the Queen Elizabeth Hospital in Birmingham.

Faron described Clevegen as 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.

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

"Approval of our CTA to conduct a Phase I/II study with Clevegen represents a significant milestone for the company," said Faron chief executive officer Dr Markku Jalkanen.

"Clevegen, our wholly-owned novel precision cancer immunotherapy drug, has already demonstrated promising preclinical results and provided human ex vivo data that supported earlier pre-clinical observations.

"We look forward to starting recruitment into the MATINS study soon and obtaining the first in vivo surrogate marker data from Clevegen treated patients during the first half of 2019."

Faron described the MATINS study as a first-in-human open label Phase I/II clinical trial, with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours.

The selected tumours under investigation were cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages.

Together, those five target groups consisted of approximately two million annual cases worldwide.

The cancer patients with high Clever-1 expression would be identified with a simple blood myeloid cell staining with Clevegen.

Faron explained that the first part of the trial would deal with safety and dose escalation to optimise dosing.

As the trial was an open-label study, the company said it expected to report initial findings as the dosing progressed.

The cohort expansion during part two would focus on identification of patients who showed an increased number of Clever-1 positive circulating monocytes, and the safety and efficacy of the treatment.

During part three, the main focus would be on assessing the efficacy of Clevegen on patients who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy.

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

In addition to Finland and the UK, Faron also planned to conduct the dose escalation part of the MATINS trial in the Netherlands, at the Erasmus University Medical Center in Rotterdam, and also wanted to increase the number of sites during the cohort expansion stage.

The company said it was also preparing a US Investigational New Drug application to expand the study there during parts two and three of the MATINS study.

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