TIDMFARN
RNS Number : 2088P
Faron Pharmaceuticals Oy
09 October 2019
Faron Pharmaceuticals Oy
("Faron" or the "Company")
MATINS TRIAL UPDATE
Study data monitoring committee has confirmed the good
tolerability of Clevegen up to 10mg/kg and confirmed Part I
expansion to secure optimal dosing for part II of the MATINS study
with advanced solid tumours
TURKU - FINLAND, 09 October 2019 - Faron Pharmaceuticals Oy
(AIM: FARN), the clinical stage biopharmaceutical company, today
announces feedback from the MATINS study data monitoring committee
("DMC") from the ongoing dose escalation study from part I of the
MATINS trial.
The phase I/II MATINS clinical trial is investigating the
tolerability, safety and efficacy of Clevegen, Faron's wholly-owned
novel precision cancer immunotherapy targeting Clever-1 positive
tumour associated macrophages (TAM), in selected metastatic or
inoperable solid tumours. The study DMC has reviewed the safety
data of all treated 11 patients and associated biomarker
analyses.
The Company has received advice to continue the study as planned
with the following notes:
-- Confirmation that Clevegen has had a good tolerability across
all dosing levels (0.3-10 mg/kg) with no dose limiting toxicity
(DLT) observed. A maximally tolerated dose (MTD) has not been
reached.
-- Immune activation was observed in all 11 subjects measured
following treatment with Clevegen and was observed as increased
circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory
T-cells (T-regs) or a substantial increase in mobile natural killer
(NK) cells in the blood. In addition, an increase in circulating
B-cells was observed during cycles three and four of the treatment,
an essential part of complete adaptive immune response.
-- The DMC observed that lower doses (0.3 and 1 mg/kg) may
potentially induce a stronger immune response than 3.0 and 10 mg/kg
doses. Consequently, the DMC proposed a new test dosing
concentration of 0.1 mg/kg instead of a higher concentration of 20
mg/kg which had previously been considered. This was most evident
in the activation of NK cells, the first line of defence of our
immune system.
The Company will adopt the DMC's advice and has decided to
expand Part I to approximately 30 patients in total to determine
optimal dosing before moving to Part II. It is expected that at the
conclusion of Part I, five patients will have been treated in each
dose level cohort. Now that a safe dose range has been confirmed,
Faron believe that the remaining patients for the trial can be
recruited relatively quickly. This expansion has no impact on US
IND filing which is progressing as previously announced.
Commenting on the IDMC feedback, Dr. Markku Jalkanen, Faron's
CEO, said: "We are encouraged by the guidance given by the MATINS
study DMC. Good safety was the first priority of Part I and now we
have obtained that status. We are also extremely happy to see that
FP-1305 is very active at low doses and that the highest dose may
not be the optimal. We believe that we can recruit these extra
patients quickly to obtain additional data to select the optimal
dose for expansion cohorts. If the optimal dose really is between
0.1-1.0 mg/kg, it provides an unusually high safety margin for
stand-alone Clevegen treatment or in combination with other cancer
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
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) 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
endothelial 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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