Faron 'encouraged' by latest Clevegen study

The AIM-traded firm said the toxicity studies were designed to fulfil regulatory requirements for three-week interval intravenous administration of Clevegen, typical for other anti-cancer antibodies currently in use.

It described FP-1305 as a humanised 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.

Faron said no toxicologically relevant changes were observed in any subject, with 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 three and 20 days after dosing in a dose-dependent manner.

No relevant changes were said to have been present in cytokines, with no anti-drug antibodies detected in any subject.

As a result, Faron said the highest dose of 100 mg/kg was considered the no-observed-adverse-effect-level.

“We are very encouraged to find out about the good safety profile of our wholly-owned asset Clevegen and the high NOAEL concentration,” said Faron chief executive officer Dr Markku Jalkanen.

“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.”