TIDMFARN
RNS Number : 9426S
Faron Pharmaceuticals Oy
22 March 2021
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Bexmarilimab (Clevegen) development update
- Significant survival benefit observed in patients responding
to bexmarilimab treatment with risk of death reduced by 88%
- Gastric cancer becomes sixth tumour cohort to show early signs of clinical efficacy
- Data monitoring committee recommends dose escalation expansion
in all six cohort types besides ongoing colorectal cancer
Company announcement, 22 March 2021 at 9.00 AM (EET)
Inside information
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company, today
announces an update from its ongoing bexmarilimab MATINS study,
indicating significant efficacy signals among a number of patients
in Part II of the trial, alongside a recommendation from the
study's data monitoring committee (DMC) to increase the dosing
frequency in all cohorts showing early clinical benefits.
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. In this trial
bexmarilimab is being investigated as a potential monotherapy in
patients with solid tumours who have exhausted all treatment
options.
As previously communicated, the first expansion stage (Part II)
of the study has progressed significantly with strong patient
recruitment across the 10 different hard-to-treat solid cancers
under investigation. The latest data includes data from 67 Part II
patients, and shows:
-- A strong survival benefit following four bexmarilimab
treatment cycles among the 10 responding patients (partial response
or stable disease as best response according to the RECIST 1.1
classification). The overall risk of death among these
bexmarilimab-responding patients was reduced by 88% (with a hazard
ratio for death of 0.119, CI 0.016-0.863) compared to
non-responding patients.
-- Within that 100 day treatment period, non-responding patients
(57) continued to show progressive disease and 85% of these
patients died (48).
-- Within the same period, only 10% of bexmarilimab-responding
patients died (1/10) and median overall survival was not reached
among these responders.
-- Responding patients showed a clear prolongation of
progression free survival (PFS), with a 93% reduction in the risk
of disease progression (with a hazard ratio for progression or
death of 0.068, CI 0.016-0.290) compared to non-responding
patients.
Dr. Markku Jalkanen, Faron's CEO, said: "This is very exciting
data supporting bexmarilimab's unique mechanism of action and
adding to the accumulating evidence of bexmarilimab's broad
potential across a range of hard-to-treat cancers. The early
observations of survival benefit and the stark contrast in
progression of disease among patients who do not respond to
bexmarilimab therapy show the clinical significance of Clever-1 as
immunotherapy target and the potential patient benefit when its
immune-suppressive control is removed. We look forward to gathering
further data from these patient cohorts to support the design of
our pivotal trials for bexmarilimab."
The Company has previously reported early signs of clinical
efficacy in five of the 10 solid tumour cohorts - colorectal
cancer, cutaneous melanoma, ovarian cancer, hepatocellular cancer
and cholangiocarcinoma. This group is now joined by gastric cancer,
as the sixth tumour cohort under investigation to have shown early
clinical benefit. Bexmarilimab has not demonstrated any benefits in
the completed uveal melanoma cohort. The remaining three cohorts -
ER+ breast cancer, pancreatic cancer and anaplastic thyroid
carcinoma - continue to be investigated.
At its recent meeting, the MATINS study's DMC proposed to Faron
that more frequent dosing schedules should be investigated in all
six cohort types showing early clinical benefit, to optimise the
treatment schedule. The DMC also recommended that higher
bexmarilimab doses should be further tested as part of the MATINS
trial. The potential of higher administration frequency at weekly
and two-weekly intervals is already underway in CRC patients, with
results expected later this year. The Company expects to report
further data from Part II cohorts in the second quarter of 2021 and
the data will be presented at an upcoming international medical
meeting.
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
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 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
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 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 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 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 .
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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