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
+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
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
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.