REG - Faron Pharma. Oy - BEXMAB Insights into Patient Profiles

Faron Pharmaceuticals OyAnnouncement

25/01/2024 07:00

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RNS Number : 8334A  Faron Pharmaceuticals Oy  25 January 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or the "Company")

 

 

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of
Responding HMA-Failed MDS Population

 

Company Announcement

 

TURKU, Finland / BOSTON, Massachusetts - January 25, 2024 - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage
biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid
cells to activate anti-tumor immunity in hematological and solid tumor
microenvironments, today provided details from its further analysis of data
from the completed Phase 1 part of the ongoing BEXMAB trial.

 

Patients are currently being enrolled in the Phase 2 of the BEXMAB trial,
which is evaluating the safety and efficacy of investigational immunotherapy
bexmarilimab at two dose levels (Project Optimus part), in combination with
standard of care (SoC), in patients with hypomethylating agents
(HMAs)-refractory or -relapsed myelodysplastic syndrome (MDS), an aggressive
myeloid leukemia with very few treatment options.

 

The new analysis of data from the Phase 1 part of the trial explores the 100%
overall response rate (ORR) achieved among both the higher-risk frontline and
HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination -
5 out of 5 patients in each population - and examines previous therapies in
the patients' treatment pathways.

 

In the HMA-failed MDS patient group:

·    Patients had been previously treated with azacitidine monotherapy or
combinations of up to four therapies that included azacitidine or decitabine +
magrolimab, venetoclax and sabatolimab

·    3 of the 5 patients were refractory to previous HMA-therapy, with
progressive disease (PD) or stable disease (SD) being the best responses
achieved from that therapy

·    2 out of the 5 patients had relapsed after treatment with azacitidine
or an azacitidine/venetoclax combination

 

"This analysis shows the deep and durable responses that can be achieved with
bexmarilimab in combination with standard of care, in MDS patients who are
refractory to HMA therapy or who have relapsed on HMA therapy or
HMA/venetoclax combination therapy," said Dr. Markku Jalkanen, Chief Executive
Officer of Faron. "Patients with high-risk MDS who have failed HMA therapy
face a poor prognosis and median overall survival in refractory MDS is just
4-6 months with no viable treatment options. Yet here we have data showing
that patients are surpassing anticipated survival rates and maintaining
remission. It is remarkable to see patients going into remission with
bexmarilimab/azacitidine after showing disease progression on all the leading
azacitidine combinations such as venetoclax, sabatolimab and magrolimab. These
are highly significant findings that provide us with continued confidence in
the potential of bexmarilimab to provide better patient outcomes and improve
the quality of life of those suffering from these aggressive conditions."

 

An updated corporate deck now contains these data and is available on the
Company's website.

 

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

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com (mailto:faron@consilium-comms.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 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.
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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