Big Picture – A Deep Dive Examination of Faron Pharmaceuticals Ltd
Faron Pharmaceuticals Ltd Snapshot
Faron is all about science. We are all about people. It's all about saving lives.
Our values outline the Faron story and summarize our identity. These two cornerstones of our existence are deeply intertwined. High-quality science makes medical discovery and innovation possible. Dedicated people make high-quality science and product development possible.
Our values tell everyone what we are all about. In the end, it’s all about saving lives.
Through exciting, new and challenging science we want to discover ground-breaking ways to battle diseases that are difficult to cure. All our determined, passionate and trustworthy professionals want to make life better for people suffering from devastating diseases.
"Research and development to find treatments for severe diseases with serious unmet medical needs is what we do. I am proud and excited to be among this group of people working hard, facing challenges and understanding the humane purpose of science. ” Dr Markku Jalkanen, CEO
Faron’s clinical pipeline is based on endothelial receptors involved in regulation of immune responses
Faron has identified several molecular mechanisms involved in the control of endothelial functions as a source of innovation. The company currently has a pipeline focusing on acute organ traumas, cancer immunotherapy and vascular damage. The fast evolving Faron pipeline consists of drug candidates (FP-1201-lyo and FP-1305) from two major Faron programmes – Traumakine® and Clevegen®, respectively. The lead indication of the Traumakine programme is Acute Respiratory Distress Syndrome (ARDS). This and the other indications (Rupture of Abdominal Aortic Aneurysm RAAA) are all based on the same Chemistry and Manufacturing Controls (CMC) dossier sections, allowing fast protocol adjusted filing for indication expansion. Similarly, Clevegen indications utilise one common dossier with a protocol adapted to each indication.
”Endothelial barrier is everything” - The endothelial surface of exhaustive capillary networks of central organs controls the fluid and cell balance between circulation and tissues. The endothelium is also a critical factor in many devastating diseases, such as organ failure and cancer metastasis. Faron’s pipeline is based on endothelial receptors involved in the regulation of immune responses and cell signalling.
Faron develops novel treatments for life-threatening medical conditions with significant unmet needs. Faron's core therapeutic areas are Acute Respiratory Distress Syndrome (ARDS), organ protection and modulation of the immune system.
Traumakine® (FP-1201-lyo) is based on the patent-protected use of intra-venous interferon beta to prevent capillary leakage in organs under threat of ischemia and inflammation. The active pharmaceutical ingredient in Traumakine® is recombinant human IFN beta-1a.
Traumakine addresses the treatment of Acute Respiratory Distress Syndrome (ARDS), a severe, orphan lung disease. Currently there is no pharmaceutical treatment for this condition with a reported mortality rate of 30 to 45%. The scientific rationale for Traumakine treatment is based on the use of interferon-beta for the restoration of the endothelial barrier function in ARDS patients.
The mechanism behind Traumakine® development was invented by scientists at Turku University from 1995 to 2003. Through extensive research and ex-vivo studies, it was identified that a molecule called CD73 is an essential entity needed to maintain endothelial barrier function. CD73 is an ectoenzyme capable of breaking down extracellular AMP to produce locally active adenosine (Figure 1). Adenosine maintains the endothelial barrier and downregulates inflammation escalation, preventing both early vascular leakage and escalation of inflammation, which are the two early pathophysiological events leading to Acute Respiratory Distress Syndrome (ARDS).
One of the key findings that led to the development of Traumakine®, was a discovery that interferon beta-1a could enhance CD73 expression and therefore could be used to treat a range of vascular leakage conditions including ARDS. Traumakine® works by enhancing lung CD73 expression and increasing production of anti-inflammatory adenosine so that vascular leaking and escalation of inflammation are reduced.
Figure 2: Without the overlapping use of hydrocortisone IFN beta-1a activates its nuclear response element by its main transcription factor (IFR9) that moves from the cytoplasm to the nucleus (arrows) to start protein transcription. Among these proteins is CD73. B) Hydrocortisone blocks the translocation of IRF9 into the nucleus, thus preventing CD73 transcription from activating.
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicines (PIM) designation for Traumakine®. PIM designation is granted when a medicine shows early signals, based on evidence to date, that it has potential value in a disease area with significant and urgent unmet need. PIM further qualifies an accompanying application and progression of the medicine towards the next stage in UK’s EAMS process.
Following meticulous pre-clinical research Faron has conducted three clinical studies with Traumakine in the treatment of ARDS
• a phase I/II study (2009-2011)
• INTEREST, a phase III study (2015-2018)
• YODA (2018-2019), a pharmacokinetic study
Currently, Faron is conducting a clinical study with Traumakine to prevent multi-organ failure (MOF) after the emergency repair of a Ruptured Abdominal Aortic Aneurysm (RAAA).
Based on findings from the detailed analysis of INTEREST results Faron has designed a new global phase III clinical study CALIBER with Traumakine in the treatment of ARDS.
One of Faron’s key areas of focus is to develop a cancer treatment which supports the hosts' immune defences against tumours, as these are often suppressed in cancer patients. This program is called Clevegen and it revolves around a key immunological switch expressed under immunosuppressive conditions named CLEVER-1, Common Lymphatic Endothelial and Vascular Endothelial Receptor 1, which in pre-clinical studies is proven to be involved in cancer growth and spread.
The active pharmaceutical ingredient of Clevegen® is a humanized anti-Clever-1 antibody. Clevegen can switch immune suppression to immune activation in various conditions: immune-oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called 'Turn-it' ("Turn on your immunity") may be used alone or in combination with other cancer treatments.
Read more about the therapeutic areas and technologies we are exploring with Clevegen.
All tumours are infiltrated by immune cells, for example macrophages, neutrophils, T-cells, dendritic cells, mast cells, myeloid derived suppressor cells and natural killer cells. Depending on the immune cells stimulated and activated, they can either have a protective effect for the host through suppression of tumour growth or deleterious effect by promoting tumour growth, invasion, metastasis and angiogenesis. Tumour associated macrophages (TAMs) have emerged as an essential constituent of the tumour micro-environment, with influence over many aspects of cancer (proliferation and survival) as well as interaction with surrounding elements (angiogenesis, escape from antitumour specific immunity). When TAMs populate a tumour, one of the very significant influences they exert over it, is a strong increase in immune suppression. Clever-1-positive TAMs represent one major macrophage population involved in this elimination of host immune system activity against the tumour cells. Clevegen® is an anti-Clever-1 antibody which targets and eliminates Clever-1-positive TAM’s from cancer patients.
Turning on your immunity
Clevegen is an anti-Clever-1 antibody which targets Clever-1-positive TAMs in cancer patients and converts these highly immunosuppressive type 2 “healing” macrophages (M2) to type 1 “pro-inflammatory” macrophages (M1) (Figure below). M1 macrophages secrete TNF alpha and interferon gamma and home cytotoxic T cells into the tumour, which are key in killing cancer cells.
Clevegen also prevents TAM infiltration into a tumour and therefore blocks TAM accumulation at tumour sites and can, therefore, also control the tumour content of regulatory T-cells, which are dependent on TAMs in the tumour microenvironment. The reduction of activated regulatory T-cells within the tumour makes the tumour more susceptible to treatment and the host’s natural immune defences.
Faron is currently conducting (2018- ) its first-in-human clinical study MATINS with Clevegen in selected metastatic or inoperable solid tumours. The selected tumours are cutaneous melanoma, hepatobiliary, pancreatic, ovarian or colorectal cancer.
Any significant developments in Faron’s programmes are reported here.
Joukahaisenkatu 6, Intelligate
For visiting us, please use the lift of the Intelligate I building and press the button to the 6th Floor.
Phone: +358 2 469 5151
Fax: +358 2 469 5152
Email: [email protected]
Faron is located next to the Kupittaa railway station (Turku–Helsinki connection) and by the Helsinki motorway (E18). Driving from Helsinki, you should take the Kupittaa exit.
The Intelligate building has a heated indoor garage, access via Joukahaisenkatu.
Please see below for details of the Company's Nominated Adviser and other key advisers.
Nominated Adviser and Broker
Panmure Gordon (UK) Limited
One New Change
London EC4M 9AF
1 Fore Street
London EC2Y 9DT
Solicitors to the Company as to English law
21 Tudor Street
London EC4Y 0DY
Solicitors to the Company as to Finnish law
Hannes Snellman Attorneys Ltd
PO Box 333
Auditors to the Company
Pricewaterhouse Coopers Oy
P.O. Box 1015
Consilium Strategic Communications
Westwicke Partners, IR (US)
2800 Quarry Lake Drive
Baltimore, MD 21209
Investor Services Plc
Bristol BS13 8AE
Euroclear Finland Ltd
Urho Kekkosen katu 5C
Pl 1110, 00101 Helsinki