From 28th June14 Aug 2018 09:11
Number : 8306S
Faron Pharmaceuticals Oy
28 June 2018
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Faron Pharmaceuticals Ltd
("Faron" or the "Company")
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Clevegen shows good safety and potential to block Clever-1 on circulating monocytes
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·     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
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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.
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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.
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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).
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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."
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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
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