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
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.
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.