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
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.
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
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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.
