TIDMFARN
RNS Number : 1363I
Faron Pharmaceuticals Oy
10 December 2020
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Presentations at ESMO Immuno-Oncology Virtual Congress build
case for CLEVER-1 as a new immune checkpoint target
Data from ongoing PhI/II MATINS trial showcased
Role of myeloid cells in shaping the tumour microenvironment
highlighted
Company announcement, 10 December 2020 at 9.00 AM (EET)
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company, today
announces that two presentations at the European Society of Medical
Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 will showcase
data from the Company's PhI/II MATINS study and explore the role of
myeloid cells in shaping the tumour microenvironment (TME).
'CLEVER-1 a new immune checkpoint target with activity in GI
cancers', Thursday 10 December, 15.25 CET:
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 which targets
Clever-1 (Common Lymphatic Endothelial and Vascular Endothelial
Receptor 1) positive tumour-associated macrophages (TAMs),
converting them from being highly immunosuppressive to
immune-stimulating.
Full data from Part I (dose ranging) of the MATINS trial, to be
presented during an educational session by principal investigator
Petri Bono, M.D., Ph.D., show bexmarilimab to be well tolerated and
demonstrating immune activation and promising clinical anti-tumour
activity. The first expansion stage (Part II) of the study across
ten different hard-to-treat solid tumour types is ongoing and 87
percent currently recruited.
'The role of myeloid cells in shaping TME', Friday 11 December,
15.25 CET:
Tumour-associated myeloid cells, including TAMs, are known to
promote tumour growth by favouring tumour cell proliferation and
survival, thereby creating a highly immunosuppressive
microenvironment. This characteristic makes them an attractive
target for new immunotherapeutic approaches. During her educational
session, Professor Maija Hollmén, MediCity, Turku University,
Finland, will explore opportunities to overcome the undesired
effects of TAMs, including the potential of an immunotherapeutic
blockade of Clever-1 to switch immunosuppressive TAMs to
immune-stimulating TAMs and induce T-cell activation.
Dr. Markku Jalkanen, Faron's CEO, said: "Our growing
understanding of how the tumour microenvironment shields a cancer
from the immune system and fuels its growth makes it a clear target
for the next generation of immunotherapies. Everything we are
learning about bexmarilimab from its rapidly advancing development
programme across a broad range of cancer types gives us continued
confidence in the potential of this anti-Clever-1 antibody to
activate the immune system and remove T cell exhaustion."
For more information on the ESMO Immuno-Oncology Virtual
Congress 2020 visit:
https://www.esmo.org/meetings/esmo-immuno-oncology-virtual-congress-2020
About bexmarilimab
Bexmarilimab is Faron's investigative precision immunotherapy, 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.
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 bexmarilimab in ten selected metastatic or
inoperable solid tumours - cholangiocarcinoma, colorectal cancer,
cutaneous melanoma, ER+ breast cancer, gastric cancer,
hepatocellular carcinoma, ovarian cancer, uveal melanoma,
pancreatic cancer and anaplastic thyroid carcinoma - all known to
host a significant number of Clever-1 positive tumour associated
macrophages (TAM).
Part I of the trial dealt with tolerability, safety and dose
escalation to optimise dosing. As the trial is an open label study,
the Company expects to report findings as the dosing progresses.
The cohort expansion during the current Part II of the trial is
focused on identifying patients who show an increased number of
Clever-1 positive circulating monocytes and the safety and efficacy
of the treatment. 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.
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 (bexmarilimab), its
investigative 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 is currently being tested in several Phase III studies
around the world against COVID-19. Traumakine is intravenous IFN
beta-1a, which is a strong anti-viral and anti-inflammatory agent.
Faron is based in Turku, Finland. Further information is available
at www.faron.com
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 (0)20 7213 0880
Panmure Gordon (UK) Limited, Broker
Rupert Dearden
Phone: +44 (0)20 7886 2500
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 55 38 990
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
Julie Seidel
Phone: +1 212 362 1200
Email: julie.seidel@sternir.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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