TIDMFARN
RNS Number : 6492A
Faron Pharmaceuticals Oy
03 June 2021
Faron Pharmaceuticals Oy
("Faron" or the "Company")
First-in-human bexmarilimab results published in Clinical Cancer
Research
- Results reveal the role of Clever-1 receptor in supressing adaptive immunity
- Bexmarilimab's macrophage-targeting approach activates T-cells
and drives anti-tumour immune responses in cold tumours that are
not otherwise responsive to immunotherapy
Company announcement, 3 June 2021 at 9.00 AM (EET)
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company, today
announces the publication of research supporting the
immunotherapeutic blockade of Clever-1 to activate anti-tumour
immune responses in advanced cancer patients. The research,
published in Clinical Cancer Research, a journal of the American
Association for Cancer Research, analyzes the mode of action of
bexmarilimab, both in vitro and in heavily pre-treated metastatic
cancer patients from Part I (dose-finding) of Faron's ongoing Phase
I/II MATINS study.
Bexmarilimab is Faron's wholly-owned novel precision cancer
immunotherapy targeting Clever-1 (common lymphatic endothelial and
vascular endothelial receptor 1), a receptor expressed on
immunosuppressive macrophages in the tumour microenvironment. The
humanised monoclonal antibody is currently being investigated as a
potential monotherapy in patients with solid tumours who have
exhausted all treatment options. The ongoing, open label Phase I/II
multicenter MATINS study has treated more than 140 patients to
date. A recent and previously communicated analysis of data from
patients enrolled in the completed Part I and ongoing Part II of
the study identified promising anti-tumour activity in multiple
advanced solid tumours.
The research published in Clinical Cancer Research was conducted
by Dr. Maija Hollmén and colleagues at the University of Turku,
Finland - part of Faron's scientific network - and was supported by
the investigators in the MATINS study. It explores the systemic
immune signatures induced by bexmarilimab in advanced cancer
patients with solid tumours and provides a mechanistic
understanding of how a macrophage-targeted approach can promote
robust activation of T-cells. In the cancer patients studied, it
was found that administration of bexmarilimab successfully lowered
the suppressive potential of macrophage precursors circulating in
the blood. Treatment led to suppression of nuclear lipid signalling
pathways and a proinflammatory phenotypic switch in blood
monocytes. These effects were accompanied by a significant increase
and activation of peripheral T-cells with indications of antitumour
responses in some patients.
The researchers conclude that the therapeutic blockade of
Clever-1 reveals a pathway linking the innate and adaptive immune
system and that targeting macrophages can promote an immune switch,
converting immunologically ignorant tumours to an immune activated
state, supporting further exploration of Clever-1 as an
immunotherapeutic drug target.
Commenting on the findings, Dr. Maija Hollmén, Turku University,
Finland, said: "Macrophages have been proven to be critical in
driving an immunosuppressive tumour microenvironment, which
ultimately counteracts the effects of current T-cell targeting
therapies. Successfully overcoming this suppression is critical to
developing effective new cancer therapies. We have demonstrated
through this research that adaptive immune activation can be
achieved by modulating the behaviour of macrophages.
"The notable immunological finding from this research is that
anti-Clever-1 treatment can induce robust peripheral T-cell
activation in patients with advanced cancer. This systemic immune
activation is a promising feature of the clinical anti-tumour
activity of bexmarilimab."
The research, entitled "Systemic blockade of Clever-1 elicits
lymphocyte activation alongside checkpoint molecule downregulation
in patients with solid tumors" can be accessed via the link
below:
https://clincancerres.aacrjournals.org/content/early/2021/06/01/1078-0432.CCR-20-4862
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
Peel Hunt LLP, Broker
Christopher Golden, James Steel
Phone: +44 (0) 20 7418 8900
Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
Email: faron@consilium-comms.com
Stern Investor Relations
Julie Seidel, Alexa Comai
Phone: +1 (212) 362-1200
E-mail: julie.seidel@sternir.com
About bexmarilimab
Bexmarilimab is Faron's wholly-owned, investigative precision
immunotherapy with the potential to provide permanent immune
stimulation for difficult-to-treat cancers through targeting
myeloid cell function. A novel anti-Clever-1 humanised antibody,
bexmarilimab targets Clever-1 positive (Common Lymphatic
Endothelial and Vascular Endothelial Receptor 1) tumour associated
macrophages (TAMs) in the tumour microenvironment, converting these
highly immunosuppressive M2 macrophages to immune stimulating M1
macrophages. In mouse models, bexmarilimab has successfully blocked
or silenced Clever-1, activating antigen presentation and promoting
interferon gamma secretion by leukocytes. Additional pre-clinical
studies have proven that Clever-1, encoded by the Stabilin-1 or
STAB-1 gene, is a major source of T cell exhaustion and involved in
cancer growth and spread. Observations from clinical studies to
date indicate that Clever-1 has the capacity to control T cell
activation directly, suggesting that the inactivation of Clever-1
as an immune suppressive molecule could be more broadly applicable
and more important than previously thought. As an immuno-oncology
therapy, bexmarilimab has potential as a single-agent therapy or in
combination with other standard treatments including immune
checkpoint molecules. Beyond immuno-oncology, it offers potential
in infectious diseases, vaccine development and more.
About MATINS
The MATINS ( Macrophage Antibody To INhibit immune Suppression)
study is a first-in-human open label phase I/II clinical trial
investigating the tolerability, safety and efficacy of bexmarilimab
in ten different hard-to-treat metastatic or inoperable solid
tumour cohorts - cholangiocarcinoma, colorectal cancer, cutaneous
melanoma, ER+ breast cancer, gastric cancer, hepatocellular
carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and
anaplastic thyroid carcinoma - which are all known to host a
significant number of Clever-1 positive tumour-associated
macrophages (TAMs). The completed Part I of the trial dealt with
tolerability, safety and dose escalation. The ongoing Part II is
focused on identifying patients who show an increased number of
Clever-1 positive TAMs and exploring safety and efficacy. Part III
will be focused on assessing efficacy. Data from MATINS have shown
that bexmarilimab has the potential to be the first macrophage
immune checkpoint therapy. To date, the investigational therapy has
been shown to be safe and well-tolerated, making it a low-risk
candidate for combination with existing cancer therapies, and has
demonstrated early signs of clinical benefit in patients who have
exhausted all other treatment options.
About Faron Pharmaceuticals Oy
Faron (AIM: FARN, First North: FARON) is a clinical stage
biopharmaceutical company developing novel treatments for medical
conditions with significant unmet needs caused by dysfunction of
our immune system. The Company currently has a pipeline based on
the receptors involved in regulation of immune response in
oncology, organ damage and bone marrow regeneration. Bexmarilimab,
a novel anti-Clever-1 humanised antibody, is its investigative
precision immunotherapy with the potential to provide permanent
immune stimulation for difficult-to-treat cancers through targeting
myeloid function. Currently in Phase I/II clinical development as a
potential therapy for patients with untreatable solid tumours,
bexmarilimab has potential as a single-agent therapy or in
combination with other standard treatments including immune
checkpoint molecules. Traumakine(R) is an investigational
intravenous (IV) interferon beta-1a therapy for the treatment of
acute respiratory distress syndrome (ARDS) and other ischemic or
hyperinflammatory conditions. Traumakine(R) is currently being
evaluated in global trials as a potential treatment for
hospitalised patients with COVID-19 and with the 59th Medical Wing
of the US Air Force and the US Department of Defense for the
prevention of multiple organ dysfunction syndrome (MODS) after
ischemia-reperfusion injury caused by a major trauma. Faron is
based in Turku, Finland. Further information is available at
www.faron.com .
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