REG - Faron Pharma. Oy - Positive Phase 2 Interim Results from BEXMAB Trial

Faron Pharmaceuticals OyAnnouncement

27/11/2024 07:00

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RNS Number : 7654N  Faron Pharmaceuticals Oy  27 November 2024

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 66(th) 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 66(th) 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
(https://faron.videosync.fi/bexmab-study-update-dec2024/register)

 

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 (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 (mailto: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
(http://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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