RCS - Faron Pharma. Oy - New biomarker data from BEXMAB study at EHA2023

Faron Pharmaceuticals OyAnnouncement

09/06/2023 08:00

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RNS Number : 1782C  Faron Pharmaceuticals Oy  09 June 2023

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

Press Release, June 9, 2023

TURKU, FINLAND / BOSTON, MA - 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
(https://otp.tools.investis.com/clients/uk/faron1/rns/regulatory-story.aspx?cid=2223&newsid=1681242)
and April
(https://www.faron.com/news-events/news-and-press-releases?rnsid=1681242&cid=2223)
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:      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)
 Poster ID:  P542
 Date/Time:  June 9, 2023 at 6pm EST

 

The poster is available on Faron's website at
https://www.faron.com/investors/most-recent-presentations
(https://www.faron.com/investors/most-recent-presentations) .

 

Investor contacts:

US, Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com (mailto:julia.balanova@faron.com)

Phone: +1 (917) 306-6096

 

EUR, Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations

yrjo.wichmann@faron.com (mailto: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 (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. 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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