REG - Faron Pharma. Oy - FDA Grants Fast Track Designation for Bexmarilimab

Faron Pharmaceuticals OyAnnouncement

27/08/2024 07:00

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RNS Number : 6729B  Faron Pharmaceuticals Oy  26 August 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or the "Company")

 

 

Inside Information: FDA Grants Fast Track Designation for Bexmarilimab in r/r
MDS

 

Company announcement, Inside Information, 26 August 2024 at 7:00 a.m. BST /
9:00 a.m. EEST

 

Key highlights

-      Given the strong data seen in Phase 1 and continuing in Phase 2 of
Faron's BEXMAB trial, the FDA has granted Fast Track Designation (FTD) for
bexmarilimab for the treatment of r/r MDS

-      FTD further strengthens the bexmarilimab program by offering
clinical development and commercialization benefits

 

TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor
targeting approach to reprogramming myeloid cells to activate anti-tumor
immunity in hematological and solid tumors, today announces that their lead
candidate bexmarilimab has been granted Fast Track Designation for the
treatment of relapsed or refractory myelodysplastic syndrome  (r/r MDS) in
combination with azacitidine by the USA Food and Drug Administration (the
FDA).

 

Fast Track Designation is granted by the FDA for products that are intended
for the treatment of serious or life-threatening disease or conditions, which
demonstrate the potential to address an unmet medical need. The designation
offers the opportunity for frequent interactions with the FDA to discuss the
drug's development plan and ensure collection of appropriate data needed to
support drug approval, as well as eligibility for rolling submission of a New
Drug Application.

 

Given the previously reported promising results in both Phase 1 and 2 of
Faron's BEXMAB trial when treating r/r MDS patients using a combination of
bexmarilimab and azacitidine to overcome primary or developed resistance to
azacitidine, bexmarilimab has been granted Fast Track Designation subsequent
to the accelerated development plan proposed by the FDA in July 2024. "This
news highlights the urgency for new treatment options besides HMAs for the
treatment of higher-risk MDS and solidifies our case that bexmarilimab can
overcome resistance to HMAs", says Dr. Juho Jalkanen CEO of Faron. Relapsed or
refractory myelodysplastic syndrome is an aggressive and deadly form of blood
cancer, for which there is very limited treatment option and a median survival
of only 5-6 months. The standard of care for higher-risk MDS is azacitidine or
another hypomethylating agent (HMA). Unfortunately, the majority of patients
eventually relapse or are non-responsive to HMAs, which then leads to r/r MDS.
Currently around 180,000 - 510,000 people globally live with an MDS diagnosis.

 

"r/r MDS is a serious life-threatening condition with limited treatment
options and therefore highly significant unmet medical need. Our trial results
to date in hypomethylating agent (HMA)-failed MDS have shown bexmarilimab's
efficacy to induce deep, clinically meaningful responses for these patients.
This FDA Fast Track Designation significantly strengthens bexmarilimab's
position to become a new cornerstone treatment of r/r MDS and will facilitate
the development of bexmarilimab for full market approval in r/r MDS. It also
represents a significant additional recognition of the potential of myeloid
cell reprogramming in overcoming resistance and activating immune system in
the treatment of various hematological and solid tumors" says Dr. Bono, the
CMO of Faron.

 

 

 

 

For more information please contact:

 

Investor Contact

 

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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