Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Colorectal cancer selected as a first expansion cohort for MATINS trial part 2

Selection based on observed activation of patient's immune system and shrinkage of colorectal cancer metastasis in the lung

TURKU - FINLAND, 11 April 2018 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces that the cohort expansion part of its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy, will begin with patients suffering from late-stage colorectal cancer as soon as the optimal dosing has been determined.

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 myeloid cells to immune active macrophages. This immune switch results in increased number of active tumour-killing CD8+ cells leading to robust anti-tumour activity in pre-clinical models (Viitala et al. (2019) Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-18-3016), and also reviewed by Mantovani and Bonecchi (2019) (Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-19-0483).

The decision to target colorectal cancer during the cohort expansion stage of the MATINS Phase I/II study (part 2) follows previously reported early data from the ongoing dose escalation and safety stage of MATINS which has now recruited four subjects with no safety concerns at 0.3 and 1.0 mg/kg dosing and has moved to 3 mg/kg dosing level. All dosed patients have, thus far, shown a switch in their immune profile towards more immune activation, observed as an increase in CD8+ cells, an increased CD8/CD4 ratio, decreased regulatory T-cells (T-regs) and a high appearance of mobile NK cells in the blood.

As previously reported, Faron has also received a tumour imaging report of a patient with colorectal cancer, which indicates significant shrinkage of lung metastasis (classified as a partial response according to the RECIST classification). Positively, the patient has also shown a decrease in the tumour load marker CEA (carcinoembryonic antigen), which has normalized along with treatment. In addition, the patient shows an increase in circulating B-cells, which could indicate an antibody-mediated response against the tumour. This patient, whose tumour has been classified as microsatellite instability (MSI)-low, had previously been treated with six different anti-cancer drugs, which had all failed. MSI-low colorectal patients represent around 90% of all colorectal cancers and over one million annual cases globally.

With this patient demonstrating a clinical partial response and expected immune switch, Faron is confident it has identified one group of patients who are thought to most likely respond to treatment and demonstrate an immune switch in these immunosuppressive Clever-1-positive tumour associated macrophages (TAMs).

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "We are encouraged by the data gathered so far from the MATINS study, particularly the tumour imaging report from a colorectal patient in whom all other treatments have failed, which demonstrates a partial response according to RECIST already in nine weeks. This information further supports our belief that Clevegen has the ability to function as a novel macrophage checkpoint immunotherapy for patients with currently untreatable solid cancers. Advancing MATINS into the cohort expansion stage later this year indicates our commitment to rapidly advance development of this potential therapy for patients in need of new treatment options."

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 Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

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

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 first 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.