REG - Faron Pharma. Oy - Phase 1 BEXMAB data presented at ASH

Faron Pharmaceuticals OyAnnouncement

11/12/2023 07:15

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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
(https://otp.tools.investis.com/clients/uk/faron2/rns/regulatory-story.aspx?cid=2223&newsid=1731417)
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
(http://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 (mailto: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 (mailto: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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