TIDMFARN
Faron Pharmaceuticals Oy
07 December 2023
Faron Pharmaceuticals Ltd.
("Faron" or the "Company")
Faron Announces Publication of Full Analysis from Phase 1/2
MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports
Medicine
- Bexmarilimab monotherapy shows efficacy in achieving disease
control and prolonged survival in late-stage metastatic solid
tumors
- CLEVER-1 targeting is safe and well-tolerated with no serious adverse effects
- Bexmarilimab induced macrophage activation and increased IFN
signaling in patients who achieved disease control and prolonged
survival
Press release, December 07, 2023
TURKU, Finland / BOSTON, Massachusetts - December 7, 2023 -
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pioneering macrophage
reprogramming for effective anticancer immunotherapies, today
announces the publication of the full safety and anti-tumor
efficacy results from the first-in-human Phase 1/2 MATINS trial of
bexmarilimab in patients with treatment-refractory late-stage solid
tumors in Cell Reports Medicine.
The publication, entitled, "Bexmarilimab-induced macrophage
activation leads to treatment benefit in solid tumors: the phase
I/II first-in-human MATINS trial" is available online at
Bexmarilimab-induced macrophage activation leads to treatment
benefit in solid tumors: The phase I/II first-in-human MATINS
trial: Cell Reports Medicine
"Positive Phase 1/2 data published in Cell Reports Medicine
highlights bexmarilimab's potential to overcome cancer immune
resistance by restoring macrophage immune function" said Petri
Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and
Principal Investigator of the MATINS study. "We are pleased to see
that bexmarilimab was safe and very well-tolerated, achieving
disease control and prolonged survival in a proportion of patients
with very late-stage solid tumors who have exhausted all standard
treatment options. The observed stimulation of immune responses
including macrophage activation increased IFN signaling, and
improved survival are particularly compelling given the challenging
context of the late-stage, treatment-refractory disease patient
population and the inclusion of nonimmunogenic cold tumors in this
first-in-human trial. These results validate the
macrophage-targeted approach and underscore bexmarilimab's
potential as a novel immunotherapy in late-stage cancers,
especially resistant to PD-1 blockade. We look forward to
generating additional data with this novel and innovative
macrophage-targeting immunotherapeutic antibody bexmarilimab."
Clever-1 is highly expressed by the most immunosuppressive
macrophages and contributes to impaired antigen presentation and
suppression of anti-tumor immunity. Bexmarilimab is a humanized
monoclonal anti-CLEVER-1 antibody that activates the immune system
and evokes anti-tumor responses. The Phase 1/2 first-in-human
MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade
with bexmarilimab in patients with treatment-refractory solid
tumors. The monotherapy showed no dose-limiting toxicities and
exhibited excellent safety and tolerability in over 200 patients.
Observed disease control rates were associated with improved
survival and were consistent with higher pre-treatment intratumoral
CLEVER-1 levels and low baseline IFN signaling that then increased
during treatment. Transcriptomics profiling of the tumors
demonstrated that bexmarilimab activates intra-tumoral macrophages
and stimulates IFN and T-cell receptors in a proportion of
patients, which then leads to disease control and prolonged
survival.
For more information on MATINS, please visit ClinicalTrials.gov
and reference Identifier NCT03733990.
For more information please contact:
Investor Contact
LifeSci Advisors
Daniel Ferry
Managing Director
daniel@lifesciadvisors.com
+1 (617) 430-7576
ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilimcomms.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 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 targeting 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 and as a monotherapy in last line solid
cancers. 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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