RCS - Faron Pharma. Oy - Final Patient Identified for BEXMAB Phase II Study

Faron Pharmaceuticals OyAnnouncement

31/01/2025 07:00

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RNS Number : 3579V  Faron Pharmaceuticals Oy  31 January 2025

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 66(th) 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 (mailto: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
(http://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.

 

 

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