Faron Pharmaceuticals has reported new findings from the open-label Phase I/II MATINS clinical trial of its cancer immunotherapy Clevegen for the treatment of certain metastatic or inoperable solid tumours.
Clevegen is an anti-Clever-1 antibody that can switch immune suppression to immune activation, with potential for application in oncology, infectious disease, and vaccine development.
The MATINS trial assessed the safety and efficacy of the drug in some metastatic or inoperable solid tumours.
Data revealed that the drug was well-tolerated at high doses, including 10mg/kg. Investigators did not report any dose-limiting toxicity (DLT) or maximally tolerated dose (MTD).
The trial also includes an option to administer 20mg/kg Clevegen, which Faron Pharmaceuticals plans to propose to its independent data monitoring board.
The safety profile of this higher dose would indicate high tolerability and a broad safety margin for the drug when compared to other immuno-oncology (IO) therapies.
In addition, this is expected to enable the quick launch of new trials in first-line and neo-adjuvant study settings.
According to the results, all subjects consistently achieved a switch in their immune cell profiles towards improved immune activation, which was measurable immediately after dosing.
A prolonged Clever-1 occupancy of the blood monocytes was observed during the initial two weeks of the three-week dosing cycle prior to the reduction in baseline levels before the next dosing cycle.
Such longer exposure of blood monocytes is expected to induce a stronger pro-inflammatory response.
Of the nine patients dosed during the trial, two subjects have demonstrated clinical anti-cancer responses. The company is working to determine the reason behind immune activation not turning into anti-tumour activity in all participants.
Faron Pharmaceuticals CEO Dr Markku Jalkanen said: “We believe we have the first macrophage immune checkpoint drug in clinical development promoting immune activation and are encouraged by the latest data indicating potential early efficacy and good tolerability.”
The company plans to expand its colorectal cancer (CRC) cohort, which saw two patients show clinical anti-cancer responses. It expects to seek regulatory approval based on results from the expanding MATINS trial by 2022.