Faron Pharmaceuticals Oy
("Faron" or "the Company")
Faron Announces New Biomarker Data from Phase
I/II BEXMAB Study at EHA2023 Hybrid Congress
- Bexmarilimab mode of action in AML/MDS supported with
durable Clever-1 target engagement in bone marrow, with increases
observed in T and NK cells and antigen presentation
- Clinical activity across indications, with objective responses
in 5 of 10 patients
- Dose escalation ongoing, with initiation in 2H 2023 of Phase II
in relapsed/refractory AML and MDS after failure on hypomethylating
agents
TURKU,
Finland and BOSTON,
June 9,
2023 /PRNewswire/ -- Faron Pharmaceuticals Oy (AIM:
FARN) (First North: FARON), a clinical-stage biopharmaceutical
company focused on tackling cancers via novel immunotherapies,
announces the release of new biomarker data from the ongoing Phase
I/II BEXMAB study of bexmarilimab in combination with
standard of care (SoC) in the aggressive hematological malignancies
of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The data will feature in a poster presentation at
the European Hematology Association (EHA) 2023 Hybrid Congress
on June 9, 2023.
In BEXMAB patients, a high Clever-1 expression in leukemic
blasts is associated with lower levels of antigen presentation. The
proposed mode of action of bexmarilimab in AML/MDS is now
supported by the biomarker data, which suggests durable Clever-1
target engagement in the bone marrow tumor microenvironment with
increases observed in key cell types limiting cancer growth and
spread, namely T and NK cells (up to 2-3-fold). In addition,
bexmarilimab treatment increased HLA-DR expression by
leukemic blasts, indicating improved immune recognition and
eradication of the malignant cells.
The poster also updates preliminary efficacy data, previously
communicated by the Company in January and April 2023,
showing objective responses in 5 out of 10 patients across the
first and second dose cohorts of the study (1 or 3mg/kg
bexmarilimab + azacitidine), as observed by a reduction in
bone marrow blasts, leading to complete and partial remissions. The
initial data also shows that bexmarilimab treatment is
well-tolerated without adding toxicity to standard azacitidine
therapy.
"The BEXMAB study continues to generate data that are an
excellent indication of the therapeutic potential of
bexmarilimab to change the treatment paradigm for patients
with hematological malignancies," said Marie-Louise Fjällskog,
M.D., Ph.D., Chief Medical Officer of Faron Pharmaceuticals. "We
are encouraged by the results and look forward to progressing the
BEXMAB program."
Presentation Details:
Title:
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A PHASE I/II STUDY TO
ASSESS SAFETY, TOLERABILITY AND PRELIMINARY EFFICACY OF
BEXMARILIMAB IN COMBINATION WITH STANDARD OF CARE AZACITIDINE
(DOUBLET) IN PATIENTS WITH MYELOID MALIGNANCIES
(BEXMAB)
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Poster ID:
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P542
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Date/Time:
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June 9, 2023 at 6pm
EST
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The poster is available on Faron's website at
https://www.faron.com/investors/most-recent-presentations.
Investor contacts:
US, Faron Pharmaceuticals
Julia Balanova
VP, Investor Relations
julia.balanova@faron.com
Phone: +1 (917) 306-6096
EUR, Faron Pharmaceuticals
Yrjö Wichmann
VP, Investor Relations
yrjo.wichmann@faron.com
Phone: +358 (0)40 5868 979
Media Contact
Faron Pharmaceuticals
Jennifer
C. Smith-Parker
Head of Communications
Jennifer.Smith-Parker@faron.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
Nort
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990
Consilium Strategic Communications
David Daley, Lindsey Neville
faron@consilium-comms.com
Phone: +44 (0)20 3709 5700
About Bexmarilimab
Bexmarilimab, a humanized IgG4 monoclonal antibody, binds
common lymphatic endothelial and vascular endothelial receptor-1
(Clever-1), a novel macrophage checkpoint. Clever-1 alters the
function of macrophages, a type of white blood cell that surrounds
and kills micro-organisms. High Clever-1 expression is associated
with therapeutic resistance and poor outcomes. Ex vivo treatment of
AML bone marrow cells with bexmarilimab alone or in
combination with azacitidine/venetoclax increases antigen
presentation, induces secretion of proinflammatory cytokines
(signaling proteins that help control inflammation in the body) and
increases activation of white blood cells called T cells, which
allows cancer to be targeted and eliminated.
About BEXMAB
The BEXMAB study is a first-in-human, 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 (azacytidine) treatment and to identify the recommended Phase
II dose. 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 Faron Pharmaceuticals Oy
Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON),
together with its subsidiaries, is a clinical stage
biopharmaceutical group focused on building the future of
immunotherapy by harnessing the power of the immune system to
tackle cancer. Bexmarilimab, a novel anti-Clever-1 humanized
antibody, is its investigational immunotherapy with the potential
to remove immunosuppression of cancers through targeting 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
including immune checkpoint molecules, and as a monotherapy for
untreatable solid tumors. Faron is headquartered in Turku, Finland. 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. 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.
The following files are available for download:
https://mb.cision.com/Main/19398/3783597/2116287.pdf
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230608 EHA Release June
-FINAL
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SOURCE Faron Pharmaceuticals Oy