Faron Pharmaceuticals Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

MATINS update

Second tumour regression identified, now in a melanoma patient

Company announcement, 05 March 2020 at 9.00 AM (EET)Inside information

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that in the ongoing dose finding part of the MATINS trial (Part I) a partial response has been identified in target lesions of a melanoma patient who has previously been heavily treated with immuno-oncology ("IO") and chemo therapies. According to Response Evaluation Criteria in Solid Tumors (RECIST), a partial response in target lesion is defined as a decrease of greater than 30% in that same lesion.

The patient had previously been treated with three different immune checkpoint inhibitors (pembrolizumab alone and ipililumab/nivolumab combination therapy) and had been on dabrafenib/trametinib anti-cancer treatment (BRAF-MEK inhibition) until December 2019.  Data showed that the size of the target lesion tumour (a lung metastasis) reduced by 44 percent and other non-target lesions stabilized. Biochemical tumour load marker also declined and clearance of pleura fluid was observed. The patient had received two doses of Clevegen at 1 mg/kg with 3-week interval.

During treatment with Clevegen, however, scans revealed that the patient had haemorrhagic brain metastases. These were not previously identified due to a lack of baseline brain scans prior to Clevegen administration and, according to the study protocol, resulted in the patient being removed from the trial. To prevent similar situations occurring in the future, the MATINS study protocol has been amended to include baseline brain imaging to rule out existing brain metastases.

Dr. Markku Jalkanen, Faron's CEO, said: "We are very encouraged to have a second partial target lesion responder in our dose finding part of the trial, suffering from a non-treatable melanoma and resistant to all existing anti-melanoma treatments, including immune checkpoint inhibitor combinations. Our earlier finding from the MATINS study patients indicated that Clevegen administration downregulates various negative immune checkpoint inhibitors (announced 11 December, 2019) and, based on this observed melanoma target lesion response, (IO-pre-treated) melanoma may represent a patient group which may require Clevegen-induced downregulation of checkpoints to initiate immune reaction against tumour. "

The further analysis of other MATINS Part I patients (30 patients at five different dosing levels, from 0.3 to 10 mg/kg) will continue and Company expects further analysis to become available post the next Data Monitoring Committee (DMC) meeting in late March, including recommendations of the future steps on dosing and cohort expansions.

Ends

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

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) 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 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 standard treatments including 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.