Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

MATINS study update

Substantial immune activation taking place post Clevegen administration

UK CTA approval

TURKU - FINLAND, 21 February 2019 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, today announces an update on early observations on immunity and clinical response of MATINS patients post Clevegen administration.

The phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours, is advancing as expected at trial sites in Finland. Dosing has moved to the second level (1mg/kg) with no signs of toxicity.

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 the tumour, and activates tumour-killing CD8+ cells leading to robust anti-tumour activity (Viitala et al. (2019) Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-18-3016).

Early immune biomarker data from the first two patients dosed in the MATINS trial at 0.3mg/kg indicate an increase in CD8+ and CD4+ T cells, which play a central role in cell-mediated immunity. A single dose of Clevegen increased patients' blood CD8+ cells and their CD8+/CD4+ ratio by 24% and 15%, respectively (mean of two). These patients also experienced a 22% decrease in their blood regulatory T-cell content (T-reg) on day two, which are linked to immune suppression in cancer patients. This change in immune activation resulted in a material increase in natural killer (NK) cells on day 15, by 16% in the first patient and 148% in the second patient from the pre-dose level. These alterations returned to near pre-dose levels ahead of the second dose.

During the second dosing level (1mg/kg) of the third MATINS patient, similar responses were observed but at significantly faster and higher rates. On day two CD8+ cells had increased 100%, the CD8+/CD4+ ratio by 26% and NK cells by 191%, while T-regs had declined -10% from the pre-dose value.

The Company believes these findings, while limited to the trial's first three patients (one case of melanoma and two colorectal cancers), are encouraging, alongside biochemical tumour and tumour load markers showing a decrease in carcinoembryonic antigen (CEA) and lactate dehydrogenase (LDH) serum levels. Both indicate the potential early clinical benefit provided by Clevegen for these late state cancer patients.

The Company is currently opening two UK sites (London, Birmingham) to expand the trial, following recent CTA approval by the UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA). The Company also intends to seek pre-IND advice from the US Food and Drug Administration (FDA) to open sites in USA prior to entering the cohort expansion part of the trial.

Due to high interest in potential new therapies in the immuno-oncology field, either as monotherapy or in combination, the Company is currently engaged in partnering discussions with several parties and hopes for a positive outcome from these negotiations during 2019.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "We have previously shown that Clevegen has the ability in experimental settings to convert the macrophage population from immune suppressive macrophages to immune active myeloid cells, which are believed to initiate the tumour fight by host immune cells. These initial data from the MATINS trial appear to confirm that this immune switch can also take place in cancer patients. We are very encouraged by these findings, and by the potential early clinical benefits indicated through the biochemical and tumour load indicators, following several lines of previous ineffective treatments. These biomarker data will prove valuable to help determine the optimal dose as the trial continues and we look forward to generating further data to assess durability of effect and efficacy in a larger number of patients."

About the MATINS study

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 progresses. 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.

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

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, 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 Crossley

Phone: +44 207 886 2500

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 early 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

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product. In addition, other factors which could cause actual results to differ materially include risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.