TIDMFARN
RNS Number : 4828S
Faron Pharmaceuticals Oy
06 November 2023
This announcement replaces RNS No 4144S released on 06 November
2023 at 07:00:13 which incorrectly displayed text from a historic,
previously issued announcement from 28 February 2022. The correct
announcement is below.
Faron Pharmaceuticals Ltd.
("Faron" or the "Company")
Insider information: Faron Initiates Phase 2 Part of BEXMAB
Study of Bexmarilimab in HMA-failed MDS
- MDS patients who have failed prior HMA therapy selected as
first indication to advance into Phase 2
- 3 mg/kg and 6 mg/kg doses selected in accordance with FDA's
Project Optimus initiative guidance
- Phase 2 part of the study will recruit 32 HMA-failed MDS
patients for 1:1 dose randomization with possible data release
after 20 patients have received more than two treatment cycles
Company announcement, Inside Information
TURKU, Finland / BOSTON, Massachusetts - November 06, 2023 -
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pioneering macrophage
reprogramming for effective anticancer immunotherapies , today
announces that based on guidance from the U.S. Food and Drug
Administration (FDA), hypomethylating agents (HMAs)-refractory or
relapsed myelodysplastic syndromes (MDS) has been selected as the
initial indication to advance to Phase 2 in the BEXMAB study
investigating bexmarilimab in combination with standard of care
(SoC).
The BEXMAB study is a multicenter study, taking place in Finland
and the U.S., evaluating the safety and efficacy of bexmarilimab, a
novel anti-Clever-1 humanized antibody, with SoC in patients with
aggressive myeloid leukemias.
The Phase 2 part of the BEXMAB trial will enroll a total of 32
patients with HMA-failed MDS. Patients will be randomized 1:1
between the selected recommended doses for expansion (RDE) of 3
mg/kg or 6 mg/kg bexmarilimab before moving into a Phase 2/3
extension of the study. Data from the first 20 patients (10 per
group) will be reviewed for exposure benefit for the two selected
dose levels. Post selection of final dosing Faron intends to
discuss a potential registrational study plan with the FDA.
"Expansion of the BEXMAB study into Phase 2 provides an
opportunity to build on the very promising findings we have already
observed among patients treated with bexmarilimab in the earlier
stage of the trial," said Dr. Mika Kontro, Associate Professor,
Helsinki University Hospital Comprehensive Cancer Center and
Principal Investigator of the BEXMAB trial. " With two good doses
now established for further investigation we hope to rapidly
generate further, robust data to support the potential of this
novel immunotherapy in a patient group with too few treatment
options available to them."
Data from the Phase 1 part of the study have demonstrated that
optimal target engagement can be achieved with 3 mg/kg dosing. The
highest immune activation, as observed in the accumulation of
activated immune cells in patients' bone marrow, was observed in
both 3 mg/kg and 6 mg/kg cohorts. Both dose levels have been safe
and well tolerated to date.
The 3 mg/kg and 6 mg/kg doses were selected in accordance with
the FDA's Project Optimus initiative, which aims to reform the
paradigms of dose optimization and selection in oncology drug
development.
"This is a significant milestone in the development of what we
hope will be the first macrophage-targeting immunotherapy for
patients with aggressive myeloid leukemias ," said Dr. Markku
Jalkanen, Chief Executive Officer of Faron. "The emerging
bexmarilimab data from the Phase 1 part of the study have been very
encouraging, showing continued efficacy signals and long duration
of responses. We believe that bexmarilimab has the potential to
improve patient outcomes and improve quality of life for those
suffering from MDS, addressing the longstanding unmet medical needs
in conditions which have had no new effective treatments in
decades."
Faron recently reported updated, positive data from the Phase 1
part of the BEXMAB trial. Bexmarilimab produced a 50% remission
rate in doublet dose cohorts (11 out of 22 patients.) Eight out of
11 patients achieved complete remission in the bone marrow with or
without blood count recovery. The highest overall response rate
(ORR) of 80% was observed among the previously failed HMA MDS group
(4 out of 5 patients). The bexmarilimab / SoC combination continues
to be well-tolerated at all tested dose levels with no
dose-limiting toxicities. Faron expects to open additional sites in
the U.S. and Europe to keep up with the increased recruitment
speed.
For more information on BEXMAB, please visit ClinicalTrials.gov
and reference identifier NCT05428969.
For more information on Project Optimus, visit
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
For more information please 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@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 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 BEXMAB
The BEXMAB study is a 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 and to identify the
recommended Phase II dose. 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 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 1/2 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
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