Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

MATINS TRIAL UPDATE

Study data monitoring committee has confirmed the good tolerability of Clevegen up to 10mg/kg and confirmed Part I expansion to secure optimal dosing for part II of the MATINS study with advanced solid tumours

TURKU - FINLAND, 09 October 2019 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces feedback from the MATINS study data monitoring committee ("DMC") from the ongoing dose escalation study from part I of the MATINS trial.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. The study DMC has reviewed the safety data of all treated 11 patients and associated biomarker analyses.

The Company has received advice to continue the study as planned with the following notes:

·; Confirmation that Clevegen has had a good tolerability across all dosing levels (0.3-10 mg/kg) with no dose limiting toxicity (DLT) observed. A maximally tolerated dose (MTD) has not been reached.

·; Immune activation was observed in all 11 subjects measured following treatment with Clevegen and was observed as increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or a substantial increase in mobile natural killer (NK) cells in the blood. In addition, an increase in circulating B-cells was observed during cycles three and four of the treatment, an essential part of complete adaptive immune response.

·; The DMC observed that lower doses (0.3 and 1 mg/kg) may potentially induce a stronger immune response than 3.0 and 10 mg/kg doses. Consequently, the DMC proposed a new test dosing concentration of 0.1 mg/kg instead of a higher concentration of 20 mg/kg which had previously been considered. This was most evident in the activation of NK cells, the first line of defence of our immune system.

The Company will adopt the DMC's advice and has decided to expand Part I to approximately 30 patients in total to determine optimal dosing before moving to Part II. It is expected that at the conclusion of Part I, five patients will have been treated in each dose level cohort. Now that a safe dose range has been confirmed, Faron believe that the remaining patients for the trial can be recruited relatively quickly. This expansion has no impact on US IND filing which is progressing as previously announced.

Commenting on the IDMC feedback, Dr. Markku Jalkanen, Faron's CEO, said: "We are encouraged by the guidance given by the MATINS study DMC. Good safety was the first priority of Part I and now we have obtained that status. We are also extremely happy to see that FP-1305 is very active at low doses and that the highest dose may not be the optimal. We believe that we can recruit these extra patients quickly to obtain additional data to select the optimal dose for expansion cohorts. If the optimal dose really is between 0.1-1.0 mg/kg, it provides an unusually high safety margin for stand-alone Clevegen treatment or in combination with other cancer therapies."

About the MATINS study

The MATINS study is the 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. Cancer patients with high Clever-1 expression are identified with a simple blood myeloid cell staining with Clevegen ("liquid biopsy").

Part I 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 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. The Company has already announced that colorectal cancer (CRC) has been selected as the first expansion cohort in Part II. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects 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 based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other immune checkpoint molecules. Traumakine, the Company's pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. 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", "hope", "seek", ''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 the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, 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 or other sources of funding, 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.