TIDMFARN
RNS Number : 0932G
Faron Pharmaceuticals Oy
23 November 2020
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Bexmarilimab (Clevegen) development update
- Accumulating MATINS data build foundation for further clinical development
- Five patient cohorts in MATINS study Part II already fully recruited
- Higher frequency of dosing introduced to investigate potential
for enhanced clinical responses
- Three new trials will study bexmarilimab treatment in
neoadjuvant setting, in combination with PD(L)-1 checkpoint
inhibitor and in haematological malignancies
Company announcement, 23 November 2020 at 9.00 AM (EET)
TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), the clinical stage biopharmaceutical company,
announces today an update on the MATINS study and further details
on the clinical expansion plans for bexmarilimab, its wholly-owned
novel precision cancer immunotherapy, targeting Clever-1 positive
tumour associated macrophages (TAMs) in selected metastatic or
inoperable solid tumours.
The expanded clinical development programme is intended to
generate data beyond existing hard-to-treat cancer cohorts,
exploring new patient populations and investigating combinations
with existing treatments, to build full understanding of
bexmarilimab's commercial potential dependent on this unique and
proprietary myeloid cell target.
MATINS study update
The ongoing phase I/II MATINS clinical trial is investigating
the tolerability, safety and efficacy of bexmarilimab across ten
different hard-to-treat solid tumour cohorts (cutaneous melanoma,
uveal melanoma, ovarian cancer, colorectal cancer, hepatocellular
cancer, ER+ breast cancer, pancreatic cancer, gastric cancer,
cholangiocarcinoma, anaplastic thyroid carcinoma) in the first
expansion stage (Part II) of the study. Latest data from four
cohorts - cutaneous melanoma, ovarian cancer, colorectal cancer
(CRC), and hepatocellular cancer - have demonstrated early signs of
efficacy from bexmarilimab monotherapy which, according to the
MATINS study protocol, allows them to move to Part III. Further
data from all cohorts in Part II will enable the Company to
evaluate which indications are most likely to achieve success and
should be continued further in development.
Of the cohorts in Part II, uveal melanoma, ovarian cancer,
colorectal cancer, pancreatic cancer, and cholangiocarcinoma are
now fully recruited and the rest, between 50-90 per cent recruited,
except anaplastic thyroid carcinoma, which is a new cohort awaiting
enrolment of the first patient.
Investigating alternative dosing schedules
As a result of key pharmacokinetic and pharmacodynamic
biomarkers suggesting the potential for improved clinical response
of bexmarilimab administered with a higher frequency than the
current three week interval, regulatory authorities have approved
an expansion of MATINS to include two additional CRC cohorts
receiving 1 mg/kg dosed at either weekly or two week intervals.
These cohorts have started recruiting with results expected during
H1 2021. Data from these cohorts will support the design of new and
pivotal trials for bexmarilimab.
Study of neoadjuvant bexmarilimab in colorectal and kidney
cancers
Faron expects to initiate a neoadjuvant bexmarilimab study in
colorectal cancer and clear cell renal cell carcinoma (ccRCC)
patients soon after diagnosis and prior to any other treatments.
The Company plans to evaluate bexmarilimab's ability to induce an
anti-cancer immune response in patients previously untreated or
with minimal exposure to anti-cancer treatments. Disease-free
survival will be also investigated to determine the clinical
benefit for neoadjuvant treatment.
Lung cancer combination study with anti-PD-(L)1 therapy
The Company previously reported that bexmarilimab administration
down regulates a range of immune checkpoint molecules (CTL-4, PDL-1
and PD-1) on the peripheral immune cells of cancer patients,
signalling immune activation and removal of T cell exhaustion. This
finding is consistent with the current understanding that Clever-1
is major source of T cell exhaustion and treatment resistance
against marketed checkpoint inhibitors(1) . Based on these
findings, Faron now plans to expand the bexmarilimab programme to
evaluate its safety and efficacy in a pilot study in combination
with anti-PD-(L)1 therapy in non-small cell lung carcinoma (NSCLC)
patients, where PD-(L)1 inhibition has become the standard of care,
though resistance develops in roughly 70 per cent of patients(2)
.
Potential of bexmarilimab in haematological cancers
Faron, together with Helsinki University Hospital, Finland,
plans to initiate a phase I/II bexmarilimab study in combination
with standard of care in acute myeloid leukaemia (AML)/
myelodysplastic syndrome (MDS) patients in H2 2021 to investigate
the safety and preliminary efficacy of bexmarilimab in
haematological cancers. Both AML and MDS originate from myeloid
lineage of bone marrow cells and result in impaired haematopoiesis
(the production of blood and immune cells). Due to this nature of
cell origin, they also express cell surface Clever-1, which has
been identified as a prognostic factor in AML(3) . Faron believes
that controlling Clever-1 activity on malignant cells can also
control their replication. This is evident in ex vivo experimental
settings and could be potentiated with anti-apoptotic compounds
like bcl-2 inhibitors(3) which promote cell death. Diagnostics and
ex vivo drug screen development for bexmarilimab will be included
in the study to optimise patient outcomes for targeted bexmarilimab
therapy.
Dr. Markku Jalkanen, Faron's CEO, said: "Bexmarilimab is rapidly
advancing through development and its exciting clinical activity
across multiple cancer types continues to give us confidence in
this asset's potential as a next generation immunotherapy with
broad opportunities. With the data we have seen to-date, we are
pleased to expand our bexmarilimab development programme, giving us
the opportunity to explore its potential to activate the immune
system in early stage cancers and in combination with checkpoint
inhibitors, a study of high interest for everyone in the
field."
"Our deep understanding of Clever-1 and its role in cancer
immunotherapy has brought us to where we are today and we look
forward to advancing this novel programme into haematological
cancers, the neoadjuvant setting and combination trials, in
addition to our ongoing robust basket study in late-line solid
tumours, which produces continuous data and understanding of
bexmarilimab as a foundational treatment for the removal of immune
suppression and T cell exhaustion."
References:
1) Hollmén et al. Brit. J. Cancer 2020
2) Gandhi et al. N. Eng. J. Med. 2018; 378; 2078-92
3) Lin et al. Mol. Therapy Nucleic Acids 2019; 18; 476-484
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
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
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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