Faron Pharmaceuticals Oy New data published by Clinical Cancer Research

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Faron Pharmaceuticals Oy

13 February 2019

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Potential of Clever-1 blockade in cancer monotherapy and in combination with PD-1 checkpoint inhibition

   -     New data published by Clinical Cancer Research 

TURKU - FINLAND, 13 February 2019 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the clinical stage biopharmaceutical company, today announces new data supporting the immunotherapeutic blockade of Clever-1 as an alternative to, or in combination with, PD-1 checkpoint inhibition to reactivate immunity against immunosuppressive tumours. The research, in which modulation of Clever-1 was investigated in multiple mouse cancer models, was published online in Clinical Cancer Research, a journal of the American Association for Cancer Research.

The research, conducted by Miro Viitala and colleagues at the University of Turku, Finland, part of Faron's scientific network, supports the rationale behind Faron's development of Clevegen, its fully human anti-Clever-1 antibody in clinical development, as a potential immunotherapy for cancer treatment.

Overcoming cancer-related immunosuppression presents a significant obstacle to successful cancer treatment. The researchers describe the molecular pathway by which Clever-1 controls the immunosuppressive activities of tumour-associated macrophages and report that a genetic deficiency of macrophage Clever-1 in multiple mouse models led to significant C8+ T cell activation and impairment of solid tumour growth. Comparable results were also seen during immunotherapeutic anti-Clever-1 treatment.

Notably, a synergistic anti-tumour benefit was identified when immunotherapeutic blockade of Clever-1 was combined with PD-1 checkpoint inhibition but, compared to anti-PD-1 therapy, anti-Clever-1 did not lead to T cell exhaustion. This further supports the clinical evaluation of Clever-1 targeting as a novel cancer treatment strategy and the potential of Clevegen to be used both as a standalone immunotherapy and in combination with other cancer therapies.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "We are very pleased about these published results by Faron's scientific network. We believe that the next significant step in cancer treatment is based on biomarker-guided use of selective immunotherapeutic drugs, alone or in combination. Faron's investigational immunotherapeutic, Clevegen, provides a unique new feature to these options by removing immune suppression from the tumour environment and potentially increasing efficacy of immunotherapy checkpoint molecules. We hope to see supportive biomarker changes in our MATINS trial patients during the first half of 2019 while we advance development of Clevegen as a novel therapy for patients with currently untreatable solid cancers."

Following Faron's participation in the funding of this research work, the Company has filed a new patent application for the combined use of Clevegen and immunotherapy checkpoint inhibitors to treat cancer.

Cited reference: Viitala M, Virtakoivu R, Tadayon S, Rannikko J, Jalkanen S and Hollmén M. Immunotherapeutic blockade of macrophage Clever-1 reactivates the CD8+ T cells against immunosuppressive tumors. Clinical Cancer Research on line code: DOI:10.1158/1078-0432.CCR-18-3016 and link: http://clincancerres.aacrjournals.org/cgi/content/abstract/1078-0432.CCR-18-3016

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

[e-mail]

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: [phone]

E-mail: [e-mail]

Westwicke Partners, IR (US)

Chris Brinzey

Phone: [phone]

E-Mail: [e-mail]

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: [phone]

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, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) in Phase III clinical stage. There is currently no approved pharmaceutical treatment for ARDS, even though this syndrome has very high mortality (30-40%) and high health care costs. 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

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February 13, 2019 03:57 ET (08:57 GMT)