Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Faron Announces Filing of Clinical Trial Application for precision cancer immunotherapy Clevegen

TURKU - FINLAND, 17 September 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, today announces that it has filed a Clinical Trial Application (CTA) for Clevegen, its wholly-owned novel precision cancer immunotherapy drug, in development for the treatment of selected metastatic or inoperable 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 vascular endothelial cells 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 humoral antibody production (Dunkel et al. 2018).

Today's CTA filing is a key step towards initation of Faron's MATINS study, a first-in-human open label Phase I/II adaptive design clinical trial 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.

The first part of the trial deals with safety and dose escalation to optimize the dosing. The cohort expansion parts II and III will recruit only patients who show 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 stand alone therapy or in combination with other immunotherapies like PD-1 inhibitors.

The Company plans to conduct the MATINS trial's dose escalation part in Finland, UK and Netherlands with four to five sites, and increase site numbers during the cohort expansion stage. Patient recruitement for the study is expected to begin in Q4 2018.

Dr Petri Bono, the Principle Investigator of the MATINS trial, said: "I look forward to initiating the MATINS trial patient recruitment since a truly novel approach to break the tumour immune suppression is used in this phaseI/II study. I strongly believe that new immunosuppression releasing approaches (such as anti-Clever-1 antibody) have the potential to become the next wave of cancer treatments"

Dr Markku Jalkanen, CEO of Faron, said: "We are making rapid progress with our Clevegen programme and this CTA filing is an important milestone. This precision therapy for cancers with very few treatment options has a unique mechanism of action which, coupled with promising pre-clinical data and human ex-vivo data, already indicates the product's potential in a broad range of indications. We look forward to beginning patient recruitment later this year and moving Clevegen into the clinic."

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy CrossleyPhone: +44 207 886 2500

About Clevegen®

Clevegen is based on Faron's turn-on-your-immunity technology platform. Potential indications include immuno-oncology, chronic infections and vaccination enhancement, which all involve the presence of these same macrophages as immune suppressive cell type.

In the context of cancer Clevegen, by binding Clever-1, prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation of tumour supportive cell types. It therefore reduces tumour associated suppression of the human immune system and converts the whole immune environment around a tumour to immune stimulating allowing a patient's own immune system to combat cancer, known as "immunotherapy". Clevegen elicts a local tumour effect which similar to the cell-mediated immune response against infections in normal tissues. This kind of removal of immune suppression locally limits risk of autoimmune reaction, a potentially severe side effect observed with some immune checkpoint inhibitors. The Directors of Faron believe that Clevegen is well differentiated from competing products as it specifically targets tumour promoting anti-inflammatory M2 TAMs and converts them into M1 TAMs while leaving intact the existing M1 TAMs. This unique mode of action of Clevegen induces immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity. The involvement of these Clever-1 positive myeloid cells in tumour progression can be verified from a simple blood sample analysis (liquid biopsy) making the treatment precise.

About MATINS study

MATINS study is a first-in-human open label adaptive design Phase I/II adaptive clinical trial in selected metastatic or inoperable solid tumours to investigate the safety and efficacy of Clevegen. The selected tumours are cutaneous melanoma, hepatobiliary, pancreatic, ovarian and colorectal cancer, which are all known to contain high amounts of Clever-1 positive tumour associated macrophages (TAMs). The trial is to be run in three parts. Part I will be conducted to determine the safe and tolerable dose of Clevegen, which will then be used in Part II to expand the cohorts of individual tumour types. Part III of the trial aims to confirm the efficacy of Clevegen with the cohorts selected based on Part II. The principle Investigator for the trial is Dr. Petri Bono from the Helsinki University Hospital, who has participated in several firat-in-man clinical trials in the area of immune oncology and is also a member of ESMO (European Society of Clinical Oncolgy) GU cancer Scientific Advisory Board.

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, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. There is currently no approved pharmaceutical treatment for 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