Faron Pharmaceuticals
Ltd.
("Faron"
or "the Company")
Inside Information: Faron
Announces Positive Phase 2 Interim Results from BEXMAB Trial to be
presented at ASH
Company announcement, Inside
Information, 27 November
2024
Key
highlights
- Interim Phase 2 read-out from the BEXMAB Trial confirms
earlier positive Phase 1 & 2 findings in MDS patients with
prior HMA failure
- In Phases 1 & 2, 20 MDS patients who are refractory or
relapsed on HMA (r/r MDS) and have no effective treatment options,
continue to show high objective response rate (ORR) at
80%
- The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure
are experiencing an estimated median overall survival (mOS) of
approximately 13.4 months currently, compared to the 5-6 months
that would typically be expected under standard of care
historically
TURKU, FINLAND -
Faron Pharmaceuticals Ltd. (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company focused
on tackling cancers via novel immunotherapies, today provides
Interim Phase 2 results of the ongoing BEXMAB trial in
myelodysplastic syndrome (MDS) patients that have failed a
hypomethylating agent (HMA), also known as relapsed/refractory MDS
(r/r MDS). Full analysis of the data will be presented at
the 66th American Society of Hematology (ASH)
Annual Meeting on 9 December 2024 in San
Diego, US.
The initial BEXMAB Phase 2 results
have already indicated a high ORR of 79% (11/14) amongst HMA-failed
MDS patients treated with a combination of bexmarilimab +
azacitidine. There is now a total of 20 HMA-failed MDS
patients evaluable for read-out with this novel combination. The
treatment has been well tolerated, without any dose-limiting
toxicity. The ORR in this otherwise untreatable population is
80% (16/20). Similar size patient cohorts treated with existing
alternatives have reported 0-20% ORR, without deep and durable
remissions. The estimated median overall survival of the
20 r/r MDS patients remains 13.4 months.
In summary, the updated BEXMAB results show very encouraging
efficacy and robust treatment benefit for the r/r MDS
patients. The detailed efficacy, safety and biomarker results
of the 20 r/r MDS patients treated in the BEXMAB trial will be
presented at the 66th American Society of
Hematology Annual Meeting. The BEXMAB trial is continuing to enroll
patients as planned with the next efficacy data readout for the
fully recruited BEXMAB trial patients expected around the
end of Q1 2025.
Dr. Petri Bono, Chief Medical
Officer of Faron, said: "r/r MDS is a life-threatening
haematological malignancy with limited treatment options and high
unmet medical need. Our updated trial results in r/r MDS further
enforces bexmarilimab's ability to
overcome treatment leading to clinically meaningful
deep responses. We look forward to sharing the detailed results
with the haematology community and discussing these data with
health authorities in H1 2025."
Dr. Juho Jalkanen, Chief Executive
Officer of Faron, said: "It is remarkable seeing the ORR continuing
to be so strong even as the patient population grows, as it would
typically be expected to settle at a lower level. For patients, I
believe these results are truly exciting as we take another step
closer to providing an additional option for their poorly met
treatment needs. With our repeatedly strong data, we are very much
looking forward to our continuing discussions with regulatory
agencies and partner candidates."
Faron will be hosting a virtual webinar to discuss the full
analysis of data on Tuesday, December 10, 2024 at 16.00 EET/9am
ET.
To register for the event
visit: BEXMAB
Study Update
The ASH Annual Meeting will take
place from 7-10 December 2024, in San Diego, California and
virtually. The poster will contain updated clinical data from the
trial.
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
PST
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 will be available on
the Company's website at https://www.faron.com/investors
once presented at ASH.
For
more information please contact:
ICR Healthcare
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 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
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.