TIDMFARN
RNS Number : 2523W
Faron Pharmaceuticals Oy
11 December 2023
Faron Pharmaceuticals Ltd.
("Faron" or the "Company")
Inside information: Faron Presents Phase 1 Data from BEXMAB in
Myeloid Malignancies Trial at the 65th American Society of
Hematology (ASH) Annual Meeting
- Significant overall Response Rate (ORR) achieved in both
HR-MDS (5/5) and HMA-failed MDS (5/5) patients
- The vast majority of responses are deep and durable with 7/10
MDS patients achieving CR/mCR and one additional patient
transferred to stem cell transplantation
Company Announcement, Inside Information
TURKU, Finland / BOSTON, Massachusetts - December 11, 2023 -
Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pioneering macrophage
reprogramming for effective anticancer immunotherapies , today
announced very positive Phase 1 data from the ongoing BEXMAB study
in myeloid malignancies, being presented at the 65th American
Society of Hematology (ASH) Annual Meeting & Exposition taking
place until tomorrow, December 12, 2023, in San Diego, California,
and virtually.
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 standard of care in
patients with aggressive myeloid leukemias.
"The BEXMAB results continue to improve over time showing
remarkable overall response rate in both higher-risk frontline as
well as hypomethylating agent (HMA)-failed myelodysplastic syndrome
(MDS) patients," said Dr. Markku Jalkanen, Chief Executive Officer
of Faron. "The combination is well-tolerated and generates strong
and durable leukemic blast eradication and immune responses. This
solidifies bexmarilimab's unique and leading mechanism of action in
the field of myeloid cell re-programming. With this compelling
evidence we are well positioned to advance to the Phase 2 part of
the BEXMAB study and actively pursue further regulatory
interactions to navigate and refine the pivotal pathway for BLA
filing".
Dr. Naval Daver, MD, Professor of Leukemia at The University of
Texas MD Anderson Cancer Center and site Principal Investigator of
the BEXMAB trial commented: "Addressing MDS poses a considerable
therapeutic challenge given the limited efficacy of the current
standard of care resulting in relatively low response rate and poor
overall survival, especially in TP53 mutated and HMA-failed MDS
patient populations. The data presented at ASH are promising,
demonstrating a higher ORR and prolonged response duration in this
trial compared to published historical benchmarks. These findings
underscore the future potential of this combination in advancing
the treatment of higher-risk and HMA-failed MDS."
Poster highlights include:
-- Significant overall response rate observed in both previously
HMA-failed (5 out of 5) and higher-risk MDS patient (5 out of 5)
populations
-- Observed responses were primarily deep and durable with 7/10
MDS patients achieving CR/mCR, and two demonstrating PR, out of
which one moved on to receive a stem cell transplantation and one
hematological improvement without remission (HI-P)
-- The majority of higher-risk MDS patients were also TP53
mutated, typically associated with poor responsiveness to standard
therapy, however all of them achieved CR/mCR upon receiving the
treatment
-- Clinical activity with 13/28 (48%) objective responses
observed across all the indications, including r/r AML, and dose
levels tested
-- The combination of bexmarilimab and azacitidine remains well
tolerated with immune-related adverse events observed at higher
dose levels
-- Clever-1 target engagement was confirmed in the bone marrow
of treated patients together with an increased antigen presentation
capacity and increased numbers of CD8 T and NK cells in
patients
Poster presentation details:
Title: Encouraging Efficacy Observed in BEXMAB Study: A Phase
1/2 Study to Assess Safety and Efficacy of Bexmarilimab in
Combination with Standard of Care in Myeloid Malignancies
Session Date and Time : Sunday, December 10, 2023, 6:00 PM - 8:00 PM PST
Session Title: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Location: San Diego Convention Center, Halls G-H
Lead Authors: Mika Kontro, Helsinki University Hospital and
University of Helsinki and Naval Daver, The University of Texas MD
Anderson Cancer Center
Abstract Number: 2915
For more information on ASH poster, please visit
www.faron.com
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
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 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 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 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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