Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Clevegen shows good safety and potential to block Clever-1 on circulating monocytes
· Wholly-owned Clevegen (FP-1305) shows no toxicity in dose escalation studies in large preclinical models
· The no-observed-adverse-effect-level (NOAEL) was 100 mg/kg, which is roughly 30 times higher concentration than needed for Clever-1 occupancy in vivo
· Clevegen also blocked Clever-1 on circulating monocytes as expected. The duration of blocking was dose dependent and resumed to normal level in 20 days in the highest dose
· The Company expects CTA filing for MATINS study in Q3 2018 and first patient recruitment in Q4 2018
TURKU - FINLAND, 28 June 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, today announces successful toxicity studies and control of blood Clever-1 positive monocytes, precursor cells to tumour associated macrophages (TAM) in large preclinical models.
The toxicity studies were designed to fulfil regulatory requirements for 3-week interval intravenous administration of Clevegen, typical for other anti-cancer antibodies currently in use. FP-1305 is a humanized IgG4 monoclonal antibody produced in CHO -cells by Faron collaborator Abzena. The FP-1305 drug product in its final formulation was administered as a single dose at 3, 30 and 100 mg/kg.
No toxicologically relevant changes were observed in any subject. No major changes were observed after treatment with FP-1305 in T lymphocytes subsets. The binding of Clevegen to its receptor on circulating CD14+ monocytes was confirmed by investigating the receptor occupancy, the recovery of which occurred between 3 to 20 days after dosing in a dose-dependent manner. No relevant changes were present in cytokines and no anti-drug antibodies (ADA) were detected in any subject. Therefore, the highest dose of 100 mg/kg was considered the no-observed-adverse-effect-level (NOAEL).
Dr Markku Jalkanen, CEO of Faron, said: "We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NOAEL concentration. We were also delighted to learn that Clevegen administration blocks Clever-1 on circulating monocytes, which are one group of our target cells in our MATINS Phase I/II clinical trial. Our plan is now to file the MATINS clinical trial application (CTA) during Q3 2018 and, as previously announced, initiate this first Clevegen human trial in Q4 2018."
About MATINS trial: MATINS study is first-in-human open label Phase I/II adaptive clinical trial in selected metastatic or inoperable solid tumours to investigate the safety and efficacy of Clevegen (FP-1305). The selected tumours are cutaneous melanoma, hepatobiliary, pancreatic, ovarian or colorectal cancer, which are all known to contain high amounts of Clever-1 positive TAMs. The trial is to be run in three parts. Part I will be conducted to determine the safe and tolerable dose of Clevegen, which will then be used in Part II to expand the cohorts of individual tumour types. Part III of the trial aims to confirm the efficacy of Clevegen with the cohorts selected based on Part II.
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
[email protected]
Consilium Strategic Communications
Mary-Jane Elliott, Matthew Neal, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: [email protected]
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: [email protected]
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley, Emma Earl, Ryan McCarthy
Phone: +44 207 886 2500
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, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (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.faron.com
