Faron Pharmaceuticals Oy Faron receives CTA approval for Clevegen (1155J)

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RNS Number : 1155J

Faron Pharmaceuticals Oy

03 December 2018

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Faron receives regulatory approval to initiate clinical MATINS trial for precision cancer immunotherapy Clevegen

TURKU - FINLAND, 03 December 2018 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, today announces that its Clinical Trial Application (CTA) 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). Patient recruitment into the Phase I/II MATINS study is expected to commence shortly at Helsinki and Oulu University Hospitals in Finland.

The same CTA is also under review by the UK's regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) for opening sites in the UK (the Royal Marsden Hospital in London and the Queen Elisabeth Hospital in Birmingham).

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. Clever-1, a cell surface receptor expressed mainly by tumour vasculature and monocytes/macrophages, has been shown to control tumour growth (Karikoski et al., 2014), cell-mediated immunity (Palani et al. 2016) and to participate in the control of B cell response and antibody production (Dunkel et al. 2018).

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "Approval of our CTA to conduct a Phase I/II study with Clevegen represents a significant milestone for the Company. Clevegen, our wholly-owned novel precision cancer immunotherapy drug, has already demonstrated promising pre-clinical 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 H1-2019."

The MATINS study is 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 are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen ("liquid biopsy").

The first part of the trial deals with safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial findings as the dosing progress. The cohort expansion during part two will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. During part three the main focus will 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, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

In addition to Finland and the UK, the Company also plans to conduct the MATINS trial's dose escalation part in the Netherlands (Erasmus University Medical Center in Rotterdam), and plans to increase the number of sites during the cohort expansion stage. The Company is also preparing a US IND to expand the study to the USA during parts two and three of the MATINS study.

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

[e-mail]

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: [phone]

E-mail: [e-mail]

Westwicke Partners, IR (US)

Chris Brinzey

Phone: [phone]

E-Mail: [e-mail]

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: [phone]

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company's lead candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com

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December 03, 2018 02:00 ET (07:00 GMT)