Faron Pharmaceuticals
Ltd.
("Faron"
or "the Company")
Faron Presents Full Analysis
of Positive Phase 2 Interim Data from BEXMAB Trial at
the 66th American Society of Hematology (ASH) Annual
Meeting
Press release, 10 December 2024
Poster highlights
- Overall response rate of 80% (16 out of 20) in refractory or
relapsed HMA failed MDS patient population (r/r MDS)
- Observed responses were primarily deep and durable with 70%
(14 out of 20) r/r MDS patients achieving complete response (CR) /
marrow complete remission (mCR) / partial response (PR).
- Four patients have moved on to receive a bone marrow
transplant
- Estimated median overall survival (mOS) of approximately 13.4
months in r/r MDS population
- The combination of bexmarilimab and azacitidine remains
well tolerated
- Clever-1 target engagement and expression in the bone marrow
with an increased antigen presentation capacity and presence of CD8
T and NK cells supports bexmarilimab
mechanism-of-action
- Webinar scheduled today at 16.00 EET/9am ET/6am PT (please see
link to register below)
TURKU, FINLAND -
Faron Pharmaceuticals Ltd. (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company focused
on tackling cancers via novel immunotherapies, today announced full
analysis of the positive Phase 2 interim readout presented at
the 66th American Society of Hematology
(ASH) Annual Meeting and Exposition.
"The BEXMAB results continue to
improve over time showing a remarkable 80% ORR in r/r MDS
patients," said Dr. Juho Jalkanen,
Chief Executive Officer of Faron. "The combination is
well-tolerated and generates strong and durable cancer blast
reduction and hematological improvements. This solidifies
bexmarilimab's unique and
leading mechanism of action for the treatment of MDS and in the
field of myeloid cell re-programming. With this compelling
evidence, we are well positioned to advance to the full Phase 2
efficacy readout and actively pursue further regulatory
interactions to navigate and refine the pivotal pathway for BLA
filing."
Dr.
Mika Kontro, MD, PhD,
Associate
Professor at the Helsinki University Hospital Comprehensive Cancer
Center and Principal Investigator of the BEXMAB trial,
said: "Addressing MDS remains a
considerable therapeutic challenge due to the limited efficacy of
the current standard of care, particularly in TP53 mutated and HMA-failed MDS
patient populations. The data presented at ASH are highly
promising, showing notable improvements in overall response rate
and overall survival. These findings
highlight the meaningful strides Faron is making in improving
treatment outcomes for r/r MDS."
The BEXMAB study is a multicenter
study, taking place in Finland, UK 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.
Faron will host a virtual webinar to discuss the full analysis
of data today, 10 December 2024 at 16.00 EET/9am ET/6am
PT.
To register for the event
visit: BEXMAB
Study Update
The ASH Annual Meeting takes place
from 7-10 December 2024, in San Diego, California and
virtually.
ASH
Poster presentation details:
Title:
Encouraging Efficacy of
Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in
Bexmab Ph1/2 Study
Session Time:
Monday, 9 December
2024, 6:00 PM - 8:00 PM PT
Session
Title:
Acute Myeloid Leukemias: Investigational
Drug and Cellular Therapies: Poster III
Location:
San Diego Convention Center, Halls
G-H
Lead Authors:
Dr. Mika Kontro, MD, PhD, Associate
Professor at the University of Helsinki; Dr. Naval Daver, MD,
Associate Professor of Leukemia at The University of Texas MD
Anderson Cancer Center
Abstract Number:
4265
The full Poster is available on the
Company's website at https://www.faron.com/investors
and contains updated clinical data from the BEXMAB
trial.
For
more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey
Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.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 I/II 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
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"expect", "hope", "seek", ''envisage'', ''estimate'', ''intend'',
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to assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
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(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
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