19 April 2017
Faron and the University of Birmingham to collaborate on Clevegen® clinical program in liver cancer Faron Pharmaceuticals Oy
TURKU – FINLAND, 18 April 2017. Faron Pharmaceuticals Ltd (”Faron”) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce that it has signed an agreement with the University of Birmingham Medical School, UK, to initiate a liver cancer program testing Clevegen, the Company’s immuno switch antibody, in clinical trials.
This collaboration will focus on trial and protocol design for a Phase I/II trial, TIETALC, (Tumour Immunity Enabling Technology Against Liver Cancer) in liver cancer patients at Birmingham Health Partners’ NIHR Clinical Research Facility and the Centre for Liver Research.
As part of the preparations, approval will be sought from the UK regulatory authorities (MHRA) for an adaptive protocol, which would allow flexible administration of Clevegen based on results obtained in previous dosings. Faron and the University of Birmingham anticipate filing the clinical trial application (CTA) with the MHRA in late 2017 or early 2018. In the event of successful collaboration and CTA approval, it is expected that Faron and the University of Birmingham will conduct the TIETALC trial together.
The main focus of TIETALC is to study the safety, pharmacokinetics/pharmacodynamics and initial efficacy of Clevegen in liver cancer patients, focusing on those with hepatocellular carcinoma (HCC). The study will also examine the efficacy of Clevegen in reducing the number of Clever-1 positive, immune suppressive myeloid cells, circulating in the blood and entering tumour tissue of cancer patients where they can suppress anti-cancer immunity.
TIETALC may also assist Faron with its aim to develop a liquid biopsy based on recognition of Clever-1 positive circulating myeloid cells. This detection could potentially become a surrogate marker of improved immune capacity in response to Clevegen and assist in the selection of those target cancer patients who are likely to benefit most from Clevegn treatment.
“We are excited to start this collaboration with this world-renowned liver cancer unit in Birmingham. Their substantial clinical expertise and numerous research programmes in liver cancer treatment will provide us with a unique opportunity to assess the effect Clevegen has on immune function in these patients. We are optimistic that Clevegen will stimulate strong immune responses against the cancer, restricting tumour growth and metastasis, and thereby improving the long term survival of these patients, whose prognosis with current therapies is very poor.”
Dr Markku JalkanenCEO of Faron
About Liver Cancer
Hepatocelluar cellular carcinoma (HCC) is the most common liver cancer type and the leading cause of cancer-related morbidity and mortality worldwide. Less than 20% of HCC patients are alive five years post diagnosis and there is a clear unmet need for effective targetted therapies. HCC is usually a complication of liver cirrhosis which may be caused by viruses, toxins (including alcohol) or autoimmune liver diseases. Additionally, the liver is a frequent site of metastasis from other cancers, particularly colorectal cancer. The immune positive phenotype of HCC and reports of responses to immunotherapy suggest that is an excellent target tumour for immuno-oncology treatments by the removal of immunosuppressive white blood cells including macrophages.
Faron´s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages. Clever-1 is involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is a humanised anti-Clever-1 antibody.
Clevegen, by binding Clever-1 prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation into tumour supportive cell types. It therefore reduces suppression of the human immune system and converts the whole immune environment around a tumour to immune stimulating allowing a patient's own immune system to combat cancer, known as “immunotherapy”. Clevegen has a local tumour effect which also allows the cell-mediated immune response to attack infections in normal tissues and removal of immune suppression locally also limits risk of autoimmune reaction, a potentially severe side effect observed with some immune checkpoint inhibitors. The Directors of Faron believe that Clevegen is well differentiated from competing products as it specifically targets M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs which support immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity.
About Tumor Immunity Enabling Technology (TIET)
The TIET technology is built around the humanised anti-Clever-1 antibody FP-1305, which binds to a specific Clever-1 proprietary epitope. Clevegen® binding to this epitope activates conversion of type 2 tumour associated macrophages to type 1 macrophages, resulting in the transformation of the tumour environment from immune suppression to immune activation. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events. The TIET technology could provide a significant boost for the efficacy of other immune checkpoint molecules, as its target is unique and represents a completely separate control of immunity.
The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.
For more information, please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Lindsey Neville
Phone: +44 (0)20 3709 5700
Westwicke Partners, IR (US)
Phone: 01 339 970 2843
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson, Rebecca Anderson
Phone: +44 207 213 0880
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, Nominated Broker (UK)
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
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) undergoingPhase III clinical trials. There is currently no approved pharmaceutical treatment for ARDS. 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 pre-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 Tumour Immunity Enabling Technology ("TIET") 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.faronpharmaceuticals.com
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