TIDMFARN
RNS Number : 9987Y
Faron Pharmaceuticals Oy
09 January 2024
Faron Pharmaceuticals Ltd.
("Faron" or the "Company")
Inside information: Faron Announces First HMA-failed MDS Patient
Dosed with Bexmarilimab as part of Phase 2 of BEXMAB Trial
- Phase 2 of the trial aims to recruit 32 patients with
HMA-failed MDS and to provide final and optimized dosing for
registrational study
- Company is exploring further development opportunities within
the bexmarilimab program in hematological cancer patients following
positive feedback from the recent ASH congress
Company Announcement, Inside Information
TURKU, Finland / BOSTON, Massachusetts - January 9, 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 announced
that the first patient has been dosed in Phase 2 of the BEXMAB
trial that evaluates the safety and efficacy of bexmarilimab, 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 ongoing, randomized parallel-assigned Phase 2 part is
enrolling 32 HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose
levels of bexmarilimab. Dose levels have been selected in
accordance with the FDA's Project Optimus initiative, which aims to
reform the paradigm of dose optimization and selection in oncology
drug development. Patients are being randomized 1:1 between the
doses before moving into a Phase 2/3 study expansion. As previously
detailed, data from the first 20 patients (10 per dose group) will
be reviewed for exposure-to-benefit to compare the two selected
dose levels. Post selection of final dosing, Faron intends to
discuss a potential registrational study plan with the FDA.
"Dosing of the first patients in this advanced part of the
BEXMAB study is another significant milestone in the bexmarilimab
program, and we want to thank our clinical network again for the
rapid advancement of our program," said Dr. Birge Berns, Chief
Medical Officer of Faron. "Refractory and relapsed MDS represents a
significant therapeutic challenge and based on the recently
announced data at ASH from the Phase 1 part of this trial, we
believe that bexmarilimab has the potential to save and improve the
lives of HMA-failed MDS patients."
Faron is currently opening additional sites to speed up the
trial's rapid recruitment, ahead of a future registrational study.
The Company's key focus is to pursue an accelerated path to
approval in refractory higher risk MDS, where no treatment option
exists.
Given the positive results to date, the Company will also
explore the immunotherapy's potential in low risk MDS as well as
chronic myelomonocytic leukaemia (CMML) patients, who are currently
treated with HMA-based therapies treatment upon worsening of
disease and consider further development and expansion
opportunities with bexmarilimab in hematological cancers in the
form of partnerships.
For more information on BEXMAB, please visit ClinicalTrials.gov
and reference Identifier NCT05428969 .
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
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.
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END
RESSSFFMAELSEEF
(END) Dow Jones Newswires
January 09, 2024 02:00 ET (07:00 GMT)
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