RNS5 Mar 2020 07:10
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that in the ongoing dose finding part of the MATINS trial (Part I) a partial response has been identified in target lesions of a melanoma patient who has previously been heavily treated with immuno-oncology ("IO") and chemo therapies. According to Response Evaluation Criteria in Solid Tumors (RECIST), a partial response in target lesion is defined as a decrease of greater than 30% in that same lesion.
The patient had previously been treated with three different immune checkpoint inhibitors (pembrolizumab alone and ipililumab/nivolumab combination therapy) and had been on dabrafenib/trametinib anti-cancer treatment (BRAF-MEK inhibition) until December 2019. Data showed that the size of the target lesion tumour (a lung metastasis) reduced by 44 percent and other non-target lesions stabilized. Biochemical tumour load marker also declined and clearance of pleura fluid was observed. The patient had received two doses of Clevegen at 1 mg/kg with 3-week interval.
During treatment with Clevegen, however, scans revealed that the patient had haemorrhagic brain metastases. These were not previously identified due to a lack of baseline brain scans prior to Clevegen administration and, according to the study protocol, resulted in the patient being removed from the trial. To prevent similar situations occurring in the future, the MATINS study protocol has been amended to include baseline brain imaging to rule out existing brain metastases.
Dr. Markku Jalkanen, Faron's CEO, said: "We are very encouraged to have a second partial target lesion responder in our dose finding part of the trial, suffering from a non-treatable melanoma and resistant to all existing anti-melanoma treatments, including immune checkpoint inhibitor combinations. Our earlier finding from the MATINS study patients indicated that Clevegen administration downregulates various negative immune checkpoint inhibitors (announced 11 December, 2019) and, based on this observed melanoma target lesion response, (IO-pre-treated) melanoma may represent a patient group which may require Clevegen-induced downregulation of checkpoints to initiate immune reaction against tumour. "
The further analysis of other MATINS Part I patients (30 patients at five different dosing levels, from 0.3 to 10 mg/kg) will continue and Company expects further analysis to become available post the next Data Monitoring Committee (DMC) meeting in late March, including recommendations of the future steps on dosing and cohort expansions.
Sign In
Follow the stocks
