RCS - Faron Pharma. Oy - Faron to present data from BEXMAB study at ASH

Faron Pharmaceuticals OyAnnouncement

02/11/2023 13:00

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RNS Number : 2240S  Faron Pharmaceuticals Oy  02 November 2023

 

Faron to present Phase 1/2 data from BEXMAB Study of Bexmarilimab in
Combination with Standard of Care in Myeloid Malignancies at the 65th American
Society of Hematology Annual Meeting

 

TURKU, Finland / BOSTON, Massachusetts - November 2, 2023 - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage
biopharmaceutical company focused on tackling cancers via novel
immunotherapies, today announces that it will present Phase 1/2 data from its
ongoing BEXMAB study of bexmarilimab in combination with standard of care
(SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS) patients having failed hypomethylating agents
(HMAs), at the 65th American Society of Hematology (ASH) Annual Meeting.

The ASH Annual Meeting will take place from 9-12 December, 2023, in San Diego,
California and virtually. The poster will contain updated clinical data from
the study.

Poster presentation details:

Title:
Encouraging Efficacy Observed in BEXMAB Study: A Phase 1/2 Study to Assess
Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in
Myeloid Malignancies

Session Date and Time:                Sunday, 10 December,
2023, 6:00 PM - 8:00 PM PST

Session Title:                     Acute Myeloid
Leukemias: Investigational Therapies, Excluding Transplantation and Cellular
Immunotherapies: Poster II

Location:                             San Diego
Convention Center, Halls G-H

Lead Authors:                    Dr. Mika Kontro, MD, PhD,
Associate Professor at the University of Helsinki; Dr. Naval Daver, MD,
Associate Professor of Leukemia at The University of Texas MD Anderson Cancer
Center

Abstract Number:            2915

The full abstract, which contains data up to July 25, 2023, when the abstract
was submitted, is available online on the ASH Annual Meeting & Exposition
website: 65th ASH Annual Meeting & Exposition - Hematology.org
(https://www.hematology.org/meetings/annual-meeting)

 

About BEXMAB

 

The BEXMAB study is an open-label Phase 1/2 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
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 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 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. 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.

 

For more information on BEXMAB, please visit ClinicalTrials.gov and reference
Identifier NCT05428969.

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 ("MAR").

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com (mailto:daniel@lifesciadvisors.com)

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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

 

 

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