TIDMFARN
RNS Number : 4350W
Faron Pharmaceuticals Oy
11 December 2019
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Clevegen downregulates a range of major immuno-oncology (IO)
checkpoints in MATINS cancer patients
Biomarker analysis could guide future combination therapies with
Clevegen
Company announcement, 11 December 2019 at 9.00 AM (EET)
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company, today
announces new data from MATINS -trial patients to be presented at
the ESMO Immuno-Oncology Congress 2019 in Geneva, Switzerland.
Faron's scientific network will present the data in a plenary
lecture and more detailed biomarker data in a Mini Oral
session.
The phase I/II MATINS clinical trial is investigating the
tolerability, safety and efficacy of Clevegen, Faron's wholly-owned
novel precision cancer immunotherapy (Clevegen) targeting Clever-1
positive tumour associated macrophages (TAM), in selected
metastatic or inoperable solid tumours. The Company has previously
announced that Clevegen administration results in an immune switch
from immune suppression to immune activation.
First available set of cell surface biomarker data from a group
of seven patients to be presented at the congress show that: 1)
anti-Clever-1 treatment in cancer patients decreases a broad range
of checkpoints including PD-1, PD-L1, CTLA-4, OX40, 41BB, LAG3 and
2) co-stimulation markers CD28 and ICOS on circulating T cell
populations whereas 3) it increases the expression of activation
markers CD25 (IL-2RA), CXCR3 and CD69. In addition, anti-tumour
responses with anti-Clever-1 treatment are found to associate with
an increase in plasma interferon gamma (IFN-gamma), which is one of
the tools the immune system is using to fight against cancer.
The analysis of checkpoints (also known as exhaustion markers)
and activation markers can potentially also be used to guide the
best possible checkpoint inhibitor(s) combination treatment with
anti-Clever-1 therapy. Cell surface markers like PD-1, PD-L1,
CTLA-4, LAG3, and TIM, can then be used to monitor a patient's
response to anti-Clever-1 therapy and to evaluate the need for
combination therapy in addition to anti-Clever-therapy. The present
finding potentially provides a method for choosing the best
combination agent(s) to initiate treatment together with
anti-Clever-1 therapy after observed changes in one or more
checkpoint or activation marker expression. The Company has filed a
related patent to protect this method.
Commenting on these findings, Dr. Markku Jalkanen, Faron's CEO,
said: "We have always believed Clever-1 to be a master regulator of
immunity, but we are very encouraged to find that Clevegen can down
regulate a range of major inhibitory immune checkpoints, that
current IO therapies aim to suppress. We intend to carry out
further analysis of other MATINS patients and aim to understand
which combination of IO therapies would build the optimal host
immune activation for various cancer types or individuals. To have
one single and safe treatment as early as possible would improve
patient outcome. These results indicate that Clevegen treatment
could potentially allow increased efficacy of other IO treatments
through the biomarker analysis of patient's blood cells post
Clevegen induced immune activation, finally offering a biological
rational to guide combination therapies."
About the MATINS study
The MATINS study is the first-in-human open label Phase I/II
clinical trial with an adaptive design to investigate the safety
and efficacy of Clevegen in selected metastatic or inoperable solid
tumours. The selected tumours under investigation 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. Cancer patients with high Clever-1 expression are
identified with a simple blood myeloid cell staining with Clevegen
("liquid biopsy").
Part I 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 findings as the dosing progresses.
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.
The Company has already announced that colorectal cancer (CRC) has
been selected as the first expansion cohort in Part II. During Part
III, the main focus will be on assessing the efficacy of Clevegen
on study subjects 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 treatment, if
successful, may ultimately be used as a standalone therapy or in
combination with other immunotherapies like PD-1 inhibitors.
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 Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley (Corporate Finance)
James Stearns (Corporate Broking)
Phone: +44 207 886 2500
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN, First North: FARON) is a clinical stage
biopharmaceutical company developing novel treatments for medical
conditions with significant unmet needs. The Company currently has
a pipeline based on the receptors involved in regulation of immune
response in oncology and organ damage. Clevegen, its precision
immunotherapy, is a novel anti-Clever-1 antibody with the ability
to switch immune suppression to immune activation in various
conditions, with potential across oncology, infectious disease and
vaccine development. Currently in phase I/II clinical development
as a novel macrophage checkpoint immunotherapy for patients with
untreatable solid tumours, Clevegen has potential as a single-agent
therapy or in combination with other immune checkpoint molecules.
Traumakine, the Company's pipeline candidate to prevent vascular
leakage and organ failures, has completed a phase III clinical
trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its
future development are being finalised to avoid interfering steroid
use together with Traumakine. Faron is based in Turku, Finland.
Further information is available at www.faron.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identified by their use of terms and phrases such as "believe",
"could", "should", "expect", "hope", "seek", "envisage",
"estimate", "intend", "may", "plan", "potentially", "will" or the
negative of those, variations or comparable expressions, including
references to assumptions. These forward-looking statements are not
based on historical facts but rather on the Directors' current
expectations and assumptions regarding the Company's future growth,
results of operations, performance, future capital and other
expenditures (including the amount, nature and sources of funding
thereof), competitive advantages, business prospects and
opportunities. Such forward looking statements reflect the
Directors' current beliefs and assumptions and are based on
information currently available to the Directors.
A number of factors could cause actual results to differ
materially from the results and expectations discussed in the
forward-looking statements, many of which are beyond the control of
the Company. In particular, the early data from initial patients in
the MATINS trial may not be replicated in larger patient numbers
and the outcome of clinical trials may not be favourable or
clinical trials over and above those currently planned may be
required before the Company is able to apply for marketing approval
for a product. In addition, other factors which could cause actual
results to differ materially include the ability of the Company to
successfully licence its programmes within the anticipated
timeframe or at all, risks associated with vulnerability to general
economic and business conditions, competition, environmental and
other regulatory changes, actions by governmental authorities, the
availability of capital markets or other sources of funding,
reliance on key personnel, uninsured and underinsured losses and
other factors. Although any forward-looking statements contained in
this announcement are based upon what the Directors believe to be
reasonable assumptions, the Company cannot assure investors that
actual results will be consistent with such forward looking
statements. Accordingly, readers are cautioned not to place undue
reliance on forward looking statements. Subject to any continuing
obligations under applicable law or any relevant AIM Rule
requirements, in providing this information the Company does not
undertake any obligation to publicly update or revise any of the
forward-looking statements or to advise of any change in events,
conditions or circumstances on which any such statement is
based.
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END
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