TIDMFARN
RNS Number : 3664Z
Faron Pharmaceuticals Oy
18 September 2020
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Data from completed Part I of bexmarilimab MATINS trial
presented at ESMO Virtual Congress 2020
Company announcement, 18 September 2020 at 9.00 AM (EET)
TURKU - FINLAND, 18 September 2020 - Faron Pharmaceuticals Ltd (
" Faron") (LON: FARN), the clinical stage biopharmaceutical company
, today announces details from an oral presentation being held at
the European Society of Medical Oncology (ESMO) Virtual Congress
2020, showcasing data from the Company's ongoing MATINS trial to
the scientific community.
The ongoing phase I/II MATINS clinical trial is investigating
the tolerability, safety and efficacy of bexmarilimab, Faron's
wholly-owned novel precision cancer immunotherapy targeting
Clever-1 positive tumour associated macrophages (TAM) in selected
metastatic or inoperable solid tumours. During the on-demand mini
oral session, Petri Bono, M.D., Ph.D., principal investigator of
the MATINS study, presents data on all 30 patients in Part I of the
trial with advanced solid tumours and who had exhausted standard
therapeutic options. The presentation includes previously announced
data, highlighting:
-- Key pharmacokinetics (PK) and Clever-1 receptor occupancy
data showing that exposure to bexmarilimab in the trial was more
than dose proportional, that full (transient) Clever-1 receptor
occupancy was achieved and, despite its relatively fast clearance
from circulation, sustained pharmacodynamic effects by bexmarilimab
were observed.
-- Very good tolerability across all dosing levels with no observed dose limiting toxicity.
-- Th1-weighted immune activation in all subjects measured
following treatment with bexmarilimab. The patients also increased
circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory
T-cells (T-regs) or had a substantial increase in natural killer
cells in the blood, all of which are considered as strong signs of
this desired immune activation.
-- Promising clinical anti-tumour activity including, 1) a
long-lasting partial response of a heavily pre-treated
microsatellite stable metastatic colorectal cancer patient who had
previously been treated with six different anti-cancer drugs, which
had all failed, 2) target lesion responses in heavily pre-treated
melanoma and ovarian cancer patients.
-- Conversion of immunologically non-inflamed (cold) tumours
into inflamed (hot) tumours in patients traditionally not
responsive to currently available checkpoint inhibitors.
Commenting on the presented data, Petri Bono M.D., Ph.D.,
Terveystalo, Helsinki, Finland and principal investigator of the
MATINS trial, said: "The emerging tolerability profile and evidence
of clinical anti-tumour activity for this novel anti Clever-1
antibody are promising. These data are from patients with
difficult-to-treat cancers who had already failed all standard
therapy options and received as many as six different lines of
therapy, exhausting all future treatment options. As this trial
continues, we will learn more about this novel immunotherapy's
potential to help those cancer patients who desperately need new
treatment options."
Title: A phase I/II MATINS trial: Part 1 pharmacokinetic, safety
and efficacy results of Clever-1 blockade in advanced cancer
Presentation number: 1024MO
www.esmo.org
ENDS
For more information please contact:
Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone. +44 207 213 0880
Panmure Gordon (UK) Limited, Broker
Rupert Dearden
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
Stern Investor Relations, Inc.
Julie Seidel, Naina Zaman
Phone: +(1)212 362 1200
Email: faron@sternir.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 standard treatments including
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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