Faron Pharmaceuticals Oy First patient dosed in phase I/II MATINS study (5480K)

TIDMFARN

RNS Number : 5480K

Faron Pharmaceuticals Oy

14 December 2018

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

First patient dosed in phase I/II MATINS study of Clevegen

TURKU - FINLAND, 14 December 2018 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, today announces that the first patient has successfully been dosed in its phase I/II MATINS study of Clevegen, its wholly-owned novel precision cancer immunotherapy drug.

The study, being initiated now 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.

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 promote tumour growth (Karikoski et al., 2014), to control cell-mediated immunity (Palani et al. 2016) and to participate in the control of B cell response and antibody production (Dunkel et al. 2018). In pre-clinical models, inhibition of Clever-1 decreases tumour associated macrophages and myeloid derived suppressor cells within the 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. The intention is to reach the maximum 10mg/kg dosing level during H1 2019 and to study Clever-1 occupancy in circulating monocytes from bone marrow to tumour. Breaking down this migration and converting the monocytes from an immune suppressive to immune activating phenotype are the main goals of the first part of the study, together with tolerability and safety observations. More details on the MATINS study structure is described on www.clinicaltrials.gov (reference number NCT03733990).

Faron's scientific network has also informed the Company that Clever-1 presence in glioblastoma patients with very few treatment options associates with poor survival (n=146, p=0.0004). The Company therefore intends to file a separate protocol to study these cancer patients suffering from these aggressive brain tumours.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "We are delighted that Clevegen has advanced into the clinic. 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 USA."

About the MATINS study

The MATINS study has an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The first part of the trial deals with tolerability, 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 selected tumours under investigation in the MATINS study 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").

In addition to Finland and the UK, where the CTA is under final review following earlier conditional approval, 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 14, 2018 06:20 ET (11:20 GMT)