TIDMFARN
RNS Number : 2327M
Faron Pharmaceuticals Oy
20 January 2021
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Bexmarilimab (Clevegen) development update
- Cholangiocarcinoma becomes fifth tumour cohort to show early signs of efficacy
- Increased bexmarilimab dosing schedule and high baseline
regulatory T cell count associated with clinical benefit
- High levels of soluble Clever-1 observed in MATINS patients
- Soluble Clever-1 has the capacity to suppress T cell activation
- Increased bexmarilimab dosing frequency to counter high levels of soluble Clever-1 underway
Company announcement, 20 January 2021 at 9.00 AM PM (EEST)
Insider information
TURKU, FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company, today
announces new observations from its ongoing MATINS trial and an
update on the study.
The phase I/II MATINS clinical trial is investigating the
tolerability, safety and preliminary efficacy of bexmarilimab,
Faron's wholly-owned novel precision cancer immunotherapy targeting
Clever-1, a receptor known to be expressed on immunosuppressive
macrophages in the tumour microenvironment.
Working with Kaiku Health Ltd ("Kaiku"), a health data science
company ( www.kaikuhealth.com ), Faron is using Kaiku's artificial
intelligence platform designed to analyse patient outcomes
following treatment with cancer immunotherapies to undertake
further efficacy analysis of patient data from Part I of the MATINS
trial. This platform provides insight through data analyses of the
immunological and disease characteristics of the MATINS patients to
better define patients who respond to bexmarilimab and should
enable further refinement of bexmarilimab's clinical
development.
Latest scientific observations from the trial include the
identification of a new role for soluble Clever-1, related to its
capacity to control T-cell activation. This suggests that the
inactivation of Clever-1 as an immune suppressive molecule could be
even broader and more important than previously thought as the
immune-stimulating effects are not only limited to tumour
associated macrophages (TAM) but may also act systemically.
Dr. Markku Jalkanen, Faron's CEO, said: "I am extremely happy
about these results and wish to thank our team, our scientific
network and the MATINS clinical group for the impressive work they
have done, both progressing the trial and undertaking complex
analyses of the data during challenging times in the face of the
current pandemic. Never during my career have I seen that a high
baseline count of regulatory T cells (Tregs) predicts a good
response to a therapy. Until now, it has always been the opposite.
This is remarkable. Such observations now provide us with a much
better understanding of the next steps required for bexmarilimab's
clinical development in pivotal studies and support its potential
as a breakthrough therapy to deliver optimal clinical results in
patients with hard to treat cancers.
"The new discovery of the role of soluble Clever-1 as an immune
suppressive molecule is striking, indicating the soluble part of
this receptor could cause systemic inhibition of T-cells in all
locations of body, therefore controlling the general immune
capacity in cancer patients. We hope to be able to overcome this
inhibition just by increasing the dosing frequency of bexmarilimab
to provide maximal binding and the removal of Clever-1 from body
fluids and tissues, including tumours."
Data details
Five solid tumour types showing early signs of efficacy
As previously communicated, four solid tumour cohorts in the
first expansion stage (Part II) of the study (cutaneous melanoma,
colorectal cancer (CRC), hepatocellular cancer and ovarian cancer)
have demonstrated early signs of clinical efficacy from
bexmarilimab therapy. This group is now joined by
cholangiocarcinoma (also known as bile duct cancer) as a fifth
responsive tumour cohort. The exact way how these cohorts will be
taken forward into the protocol for Part III of the MATINS trial
will be decided in Q3-2021 after further data on the effect of
increased dosing frequency is available (recruitment currently
ongoing). More frequent dosing either weekly or at two week
intervals could increase bexmarilimab treatment efficacy further,
compared to the original dosing interval of every three weeks,
which has already led to some very promising results in several
advanced cancer types.
Regulatory T cell (Treg) marker FOXP3 and increased bexmarilimab
dosing associated with increased clinical benefit
Part I MATINS study patients had received a median of three
previous cancer treatments (mainly various chemotherapy
combinations). Half of the study patients had received four or more
lines of therapy before joining the MATINS study. Patient blood
samples have indicated reduced immune capacity reflected in low
counts of effector immune cells. To better understand patient
outcomes after bexmarilimab treatment around 50 biomarkers have now
been analysed using Kaiku's Immuno-Oncology platform resulting in
the following findings:
-- Increased bexmarilimab dosing level with three week interval
was associated with a clinical response
-- High baseline count of Treg cell marker FOXP3 was associated with a clinical response
These findings are consistent with the Company's previous
findings and understanding that cellular immune activation and the
removal of immunosuppressive elements are required for clinical
benefit from bexmarilimab. The association of clinical benefit in
patients with a high baseline count of Tregs indicates that
patients were significantly immunosuppressed before the treatment.
In these subjects, removal of immunosuppression using bexmarilimab
to inactivate Clever-1 positive myeloid cells could therefore
result in removal of Tregs known to be supported by macrophages.
The Company believes that increased dosing frequency has the
potential to produce more complete inactivation of Clever-1, either
expressed on the surface of myeloid cells or circulating in blood
and lymph as a soluble immunosuppressive molecule.
Cancer patient plasma can contain significant amounts of soluble
Clever-1
The transient Clever-1 receptor occupancy observed in all MATINS
Part I dose levels (0.1-10 mg/kg) supports the decision to increase
dosing frequency from every three weeks to either weekly or two
week intervals. Latest data show that MATINS patients' plasma
(blood devoid of cells) could contain up to a 10-fold increased
level of soluble Clever-1 compared to healthy controls. These
elevated values could explain the rapid uptake of bexmarilimab in
cancer patients. This finding also supports the potential of higher
administration frequency, which is currently ongoing in CRC
patients, with first results expected in H1-2021.
Soluble Clever-1 has the capacity to suppress T cell
activation
The role of increased soluble Clever-1 in the circulation was
tested in experimental settings. The most interesting finding from
this experimental work elucidated a new role for Clever-1: it can
control T cell activation directly, including naïve T cells. This
is a significant finding because it proposes that by producing
soluble Clever-1 the malignant process can also suppress T cell
activation in remote locations and, by targeting naïve T cells, can
prevent expansion of the T cell repertoire. Soluble Clever-1 can
therefore be a substantial inhibitor of T cell activating
therapies.
A new patent application has been filed seeking global
protection for these findings and related applications.
The observations detailed in this statement are being prepared
for peer-reviewed publication and/or presentation at future
scientific congresses.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
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 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 II is focused on identifying
patients who show an increased number of Clever-1 positive tumour
macrophages 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.
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
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
E-mail: faron@consilium-comms.com
Stern Investor Relations
Julie Seidel, Naina Zaman
Phone: +1 212 362 1200
E-mail: faron@sternir.com
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. The Company currently has
a pipeline based on the receptors involved in regulation of the
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
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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