RNS27 Jan 2020 07:09
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the second expansion cohort in its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen will be in patients with ovarian cancer.
The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours.
Initiation of this second expansion cohort follows approval from the MATINS trial's data monitoring committee earlier this month to initiate the study's first expansion cohort in patients suffering from late-stage colorectal cancer (CRC). Ovarian cancer is a tumour type known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). It presents a high unmet medical need with few available treatments for patients. Large transcript analysis of ovarian tumours indicates significant outcome differences between patients with either high or low Clever-1 expression. Patients with high Clever-1 expression have short life expectancies under current treatment options.
Dr. Markku Jalkanen, Faron's CEO, said: "Data collected so far in the MATINS trial are highly encouraging, with Clevegen establishing itself as a potential immunotherapy capable of downregulating a range of major inhibitory immune checkpoints (PD-1, PD-L1, CTLA-4) across several cancers. Initiation of this additional expansion cohort signals our commitment to rapidly progress the development of Clevegen in patients with limited effective treatment options."
Dr. Tyler Curiel, Professor and The Daisy M. Skinner President's Chair in Cancer Immunology Research, UT Health San Antonio, and MATINS trial site investigator and principal investigator for USA, said: "Ovarian cancer is devastating and there remains a huge need for new treatments. Expanding the MATINS trial to include ovarian cancer patients will help us to understand this novel potential immunotherapy in a patient group where we desperately need to improve outcomes. We are very excited to join the MATINS trial and to start US recruitment."
Existing MATINS trial sites in Europe are currently recruiting for the first expansion cohort in late-stage CRC patients and this second cohort, in a total of 10 patients with ovarian cancer, is expected to follow in the coming weeks. With good tolerability and no dose limiting toxicity signals established across all dosing levels explored in the MATINS trial to date, the dosing for this additional cohort is likely to be higher (e.g. 1 mg/kg) than for the first CRC cohort. MATINS trial sites in the US are expected to begin opening in the short term.
Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial
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