RCS - Faron Pharma. Oy - Faron presents BEXMAB data at ASH Annual Meeting

Faron Pharmaceuticals OyAnnouncement

10/12/2024 07:00

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RNS Number : 4011P  Faron Pharmaceuticals Oy  10 December 2024

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

 

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 (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 (mailto: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
(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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