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RNS Number : 5480K
Faron Pharmaceuticals Oy
14 December 2018
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
First patient dosed in phase I/II MATINS study of Clevegen
TURKU - FINLAND, 14 December 2018 - Faron Pharmaceuticals Ltd
("Faron") (LON: FARN), the clinical stage biopharmaceutical
company, today announces that the first patient has successfully
been dosed in its phase I/II MATINS study of Clevegen, its
wholly-owned novel precision cancer immunotherapy drug.
The study, being initiated now at Helsinki and Oulu University
Hospitals in Finland, is a first-in-human open label phase I/II
clinical trial to investigate the safety and efficacy of Clevegen
in selected metastatic or inoperable solid tumours.
Clevegen is a novel anti-Clever-1 antibody, which causes changes
in the immune environment of solid tumours by switching Clever-1
positive immune suppressive macrophages to immune active
macrophages. Clever-1, a cell surface receptor expressed mainly by
tumour vasculature and monocytes/macrophages, has been shown to
promote tumour growth (Karikoski et al., 2014), to control
cell-mediated immunity (Palani et al. 2016) and to participate in
the control of B cell response and antibody production (Dunkel et
al. 2018). In pre-clinical models, inhibition of Clever-1 decreases
tumour associated macrophages and myeloid derived suppressor cells
within the tumour, and activates tumour killing CD8+ cells leading
to robust anti-tumour activity. The treatment, if successful, may
ultimately be used as a standalone therapy or in combination with
other immunotherapies like PD-1/PD-L1 inhibitors.
The initial dosing level in the study is 0.3mg/kg increasing to
1mg/kg, 3 mg/kg and 10mg/kg. The intention is to reach the maximum
10mg/kg dosing level during H1 2019 and to study Clever-1 occupancy
in circulating monocytes from bone marrow to tumour. Breaking down
this migration and converting the monocytes from an immune
suppressive to immune activating phenotype are the main goals of
the first part of the study, together with tolerability and safety
observations. More details on the MATINS study structure is
described on www.clinicaltrials.gov (reference number
NCT03733990).
Faron's scientific network has also informed the Company that
Clever-1 presence in glioblastoma patients with very few treatment
options associates with poor survival (n=146, p=0.0004). The
Company therefore intends to file a separate protocol to study
these cancer patients suffering from these aggressive brain
tumours.
Dr Markku Jalkanen, Chief Executive Officer of Faron, said: "We
are delighted that Clevegen has advanced into the clinic. We have
already seen promising pre-clinical and ex-vivo human data, and so
this is a significant step in helping us to further understand the
potential of this novel therapy. We are pleased to have achieved
such rapid progress with our Clevegen programme so far and look
forward to the opening of further trial sites and the expansion of
the study in Europe and USA."
About the MATINS study
The MATINS study has an adaptive design to investigate the
safety and efficacy of Clevegen in selected metastatic or
inoperable solid tumours. The first part of the trial deals with
tolerability, safety and dose escalation to optimize dosing. As the
trial is an open label study, the Company expects to report initial
findings as the dosing progress.
The cohort expansion during part two will focus on
identification of patients who show an increased number of Clever-1
positive circulating monocytes and the safety and efficacy of the
treatment. During part three the main focus will be on assessing
the efficacy of Clevegen on patients who show an increased number
of Clever-1 positive circulating monocytes, making the treatment
precisely targeted and maximizing the chances of success for
efficacy.
The selected tumours under investigation in the MATINS study are
cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic,
ovarian and colorectal cancer, all known to host a significant
number of Clever-1 positive tumour associated macrophages (TAM).
All together these five target groups consist of approximately 2
million annual cases worldwide. The cancer patients with high
Clever-1 expression will be identified with a simple blood myeloid
cell staining with Clevegen ("liquid biopsy").
In addition to Finland and the UK, where the CTA is under final
review following earlier conditional approval, the Company also
plans to conduct the MATINS trial's dose escalation part in the
Netherlands (Erasmus University Medical Center in Rotterdam), and
plans to increase the number of sites during the cohort expansion
stage. The Company is also preparing a US IND to expand the study
to the USA during parts two and three of the MATINS study.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley
Phone: +44 207 886 2500
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline focusing on acute
organ traumas, vascular damage and cancer immunotherapy. The
Company's lead candidate Traumakine, to prevent vascular leakage
and organ failures, has completed a Phase III clinical trial in
Acute Respiratory Distress Syndrome (ARDS). An additional European
Phase II Traumakine trial is underway for the Rupture of Abdominal
Aorta Aneurysm ("RAAA"). Faron's second candidate Clevegen is a
ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has
the ability to switch immune suppression to immune activation in
various conditions, with potential across oncology, infectious
disease and vaccine development. This novel macrophage-directed
immuno-oncology switch called Turn-on-your-Immunity or Turn-It may
be used alone or in combination with other immune checkpoint
molecules for the treatment of cancer patients. Faron is based in
Turku, Finland. Further information is available at
www.faron.com
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END
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