RCS - Faron Pharma. Oy - Interactions with UK Regulatory Authorities

Faron Pharmaceuticals OyAnnouncement

02/12/2024 08:00

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RNS Number : 3747O  Faron Pharmaceuticals Oy  02 December 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or "the Company")

 

Faron Announces Positive Update on Recent Interactions with UK Regulatory
Authorities regarding bexmarilimab and expanding the BEXMAB Study to the UK

 

-      MHRA has awarded bexmarilimab an Innovation Passport for the
treatment of relapsed/refractory Myelodysplastic Syndrome and given approval
for the BEXMAB trial to be conducted in the UK

-      UK sites to join the BEXMAB Study iminently

 

Press release, 2 December 2024

 

TURKU, FINLAND - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON),
a clinical-stage biopharmaceutical company focused on tackling cancers via
novel immunotherapies, today announces that the BEXMAB Study may proceed in
the UK and bexmarilimab has received an Innovation Passport, under the
Innovative Licensing and Access Pathway (ILAP) from the UK's Medicines and
Healthcare products Regulatory Agency (MHRA), for the treatment of
relapsed/refractory Myelodysplastic Syndrome (r/r MDS).

 

The ILAP was introduced by the MHRA in 2021 to give patients quicker access to
cutting-edge treatments and therapies for life-threatening or seriously
debilitating conditions, or conditions for which there is a significant
patient or public health need. The benefits of the ILAP include enhanced
regulatory support from the MHRA and provides collaborative opportunities with
health technology assessment bodies and other stakeholders, with the aim of
accelerating the development, and improving patient access to promising new
medicines.

 

The decision to award the Innovation Passport to bexmarilimab was made by the
ILAP Steering Group, which is comprised of representatives from the MHRA,
NICE, AWTTC and SMC, and provides further regulatory verification of
bexmarilimab's potential to address significant unmet medical needs and
positions the therapy for faster development and potentially earlier access
for patients.

 

In addition, Faron today announced that it has received regulatory approval
from the MHRA to conduct the BEXMAB trial in the UK. This approval will allow
Faron to recruit UK haematology patients directly, accelerating its research
efforts by increasing recruitment and enhancing the study's diversity and
scope by expanding the participant pool.

 

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: "I am very pleased
to announce this update today following our ongoing interactions with the MHRA
regarding bexmarilimab. At Faron, we understand the importance of actively
engaging with regulatory authorities and, as a result of those interactions
and the promising data generated to date, I am very pleased that the MHRA has
recognised the potential of bexmarilimab to treat r/r MDS patients. Receiving
ILAP designation, coupled with regulatory approval to conduct the BEXMAB trial
in the UK, will allow us to accelerate the development of bexmarilimab and
give UK patients access to a promising novel therapeutic option through
participation in the study. We are looking forward to continuing our
discussions with the MHRA to further expedite bexmarilimab's path to market
for patients as soon as possible."

 

 

For more information please contact:

ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@icrhealthcare.com (mailto:faron@icrhealthcare.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 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 (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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