Faron Pharmaceuticals
Ltd.
("Faron"
or "the Company")
Faron Announces Final Patient
Identified for the BEXMAB Phase II Study in
Myelodysplastic Syndrome
Press release, 31 January
2025
On track to report topline
efficacy and safety data in April 2025
TURKU, FINLAND -
Faron Pharmaceuticals Ltd. (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company focused
on tackling cancers via novel immunotherapies, today announces that
the final patient has been identified for the BEXMAB Phase II dose
optimization study in refractory or
relapsed myelodysplastic
syndrome (r/r MDS),
as well as the BEXMAB Phase I/II study in frontline high risk (HR)
MDS. The topline response rate read out is thus expected to become
available in April 2025. Detailed data will be presented later at
upcoming major medical conferences. The reportable data set will
consist of approximately 35 r/r MDS patients and 20 frontline HR
MDS patients. The r/r MDS population will consist of 32 patients
treated with either 3mg/kg or 6mg/kg dose of bexmarilimab per the U.S. Food and
Drug Administration (FDA) Project Optimus guidance, and three r/r
MDS patients treated with 1mg/kg dose of bexmarilimab in Phase I. A similar
split between doses will be reported concerning the frontline HR
MDS population.
"Achieving this milestone for our
lead program, BEXMAB, in r/r MDS and frontline HR MDS, reflects not
only our team's strength in executing on the Company's drug
development strategy, but also the urgent unmet medical need for
patients with this difficult to treat cancer," stated Petri Bono,
M.D., Ph.D., Chief Medical Officer. "Backed by recently released
Phase II Interim Results confirming the superior profile of
bexmarilimab versus
current treatment options, we remain highly confident about the
potential of bexmarilimab
to become an important new best-in-class treatment for MDS
patients."
The BEXMAB Phase II Interim Results presented at
the 66th American Society of Hematology (ASH)
Annual Meeting on December 2024 showed a high objective
response rate (ORR) at 80% (16/20). Similar size patient cohorts
treated with existing alternatives have reported 0-20% ORR, without
deep and durable remissions. Previously reported estimated median overall
survival of the 20 r/r MDS patients were 13.4 months
compared to the 5-6 months that would typically be expected under
standard of care historically.
The BEXMAB trial will continue enrolling CMML
patients and there is also the possibility to expand the enrollment
of r/r MDS patients under the current protocol. The Company is
assessing expanding the enrollment of r/r MDS patients in order to
have this treatment option available for patients and to strengthen
the data set for upcoming regulatory purposes.
"Our BEXMAB Phase II trial has
progressed as planned and our focus now is to take this data to the
FDA and fine tune the registrational approach with the agency. We
are committed to rapidly advancing bexmarilimab through clinical
development, to bring it to treatment resistant MDS patients as
soon as possible," said Dr. Juho Jalkanen, M.D., Ph.D., Chief
Executive Officer. "I want to express my sincere gratitude to all
the stakeholders working on the BEXMAB trial, especially our
hardworking employees, study site professionals and investigators,
but most of all the patients and their loved ones."
For
more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey
Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.com
Cairn Financial Advisers LLP,
Nomad
Sandy Jamieson, Jo Turner
Phone: +44 (0) 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
About BEXMAB
The BEXMAB study is an open-label
Phase I/II clinical trial investigating bexmarilimab in combination with
standard of care (SoC) in the aggressive hematological malignancies
of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The primary objective is to determine the safety and tolerability
of bexmarilimab in
combination with SoC (azacitidine) treatment. Directly targeting
Clever-1 could limit the replication capacity of cancer cells,
increase antigen presentation, ignite an immune response, and allow
current treatments to be more effective. Clever-1 is highly
expressed in both AML and MDS and associated with therapy
resistance, limited T cell activation and poor outcomes.
About bexmarilimab
Bexmarilimab is Faron's wholly owned, investigational immunotherapy
designed to overcome resistance to existing treatments and optimize
clinical outcomes, by targeting myeloid cell function and igniting
the immune system. Bexmarilimab binds to Clever-1, an
immunosuppressive receptor found on macrophages leading to tumor
growth and metastases (i.e. helps cancer evade the immune system).
By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor
microenvironment, reprogramming macrophages from an
immunosuppressive (M2) state to an immunostimulatory (M1) one,
upregulating interferon production and priming the immune system to
attack tumors and sensitizing cancer cells to standard of
care.
About Faron Pharmaceuticals
Ltd
Faron (AIM: FARN, First North:
FARON) is a global, clinical-stage biopharmaceutical company,
focused on tackling cancers via novel immunotherapies. Its mission
is to bring the promise of immunotherapy to a broader population by
uncovering novel ways to control and harness the power of the
immune system. The Company's lead asset is bexmarilimab, a novel anti-Clever-1
humanized antibody, with the potential to remove immunosuppression
of cancers through reprogramming myeloid cell function.
Bexmarilimab is being
investigated in Phase I/II clinical trials as a potential therapy
for patients with hematological cancers in combination with other
standard treatments. Further information is available at
www.faron.com.
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 addition, other
factors which could cause actual results to differ materially
include the ability of the Company to successfully license its
programs 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.
