Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Clevegen downregulates a range of major immuno-oncology (IO) checkpoints in MATINS cancer patients

Biomarker analysis could guide future combination therapies with Clevegen

Company announcement, 11 December 2019 at 9.00 AM (EET)Inside information

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces new data from MATINS -trial patients to be presented at the ESMO Immuno-Oncology Congress 2019 in Geneva, Switzerland. Faron's scientific network will present the data in a plenary lecture and more detailed biomarker data in a Mini Oral session.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy (Clevegen) targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. The Company has previously announced that Clevegen administration results in an immune switch from immune suppression to immune activation.

First available set of cell surface biomarker data from a group of seven patients to be presented at the congress show that: 1) anti-Clever-1 treatment in cancer patients decreases a broad range of checkpoints including PD-1, PD-L1, CTLA-4, OX40, 41BB, LAG3 and 2) co-stimulation markers CD28 and ICOS on circulating T cell populations whereas 3) it increases the expression of activation markers CD25 (IL-2RA), CXCR3 and CD69. In addition, anti-tumour responses with anti-Clever-1 treatment are found to associate with an increase in plasma interferon gamma (IFN-gamma), which is one of the tools the immune system is using to fight against cancer.

The analysis of checkpoints (also known as exhaustion markers) and activation markers can potentially also be used to guide the best possible checkpoint inhibitor(s) combination treatment with anti-Clever-1 therapy. Cell surface markers like PD-1, PD-L1, CTLA-4, LAG3, and TIM, can then be used to monitor a patient's response to anti-Clever-1 therapy and to evaluate the need for combination therapy in addition to anti-Clever-therapy. The present finding potentially provides a method for choosing the best combination agent(s) to initiate treatment together with anti-Clever-1 therapy after observed changes in one or more checkpoint or activation marker expression. The Company has filed a related patent to protect this method.

Commenting on these findings, Dr. Markku Jalkanen, Faron's CEO, said: "We have always believed Clever-1 to be a master regulator of immunity, but we are very encouraged to find that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current IO therapies aim to suppress. We intend to carry out further analysis of other MATINS patients and aim to understand which combination of IO therapies would build the optimal host immune activation for various cancer types or individuals. To have one single and safe treatment as early as possible would improve patient outcome. These results indicate that Clevegen treatment could potentially allow increased efficacy of other IO treatments through the biomarker analysis of patient's blood cells post Clevegen induced immune activation, finally offering a biological rational to guide combination 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

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 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.