REG - Faron Pharma. Oy - First Patient Dosed in Ph 2 of the BEXMAB Trial

Faron Pharmaceuticals OyAnnouncement

09/01/2024 07:00

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RNS Number : 9987Y  Faron Pharmaceuticals Oy  09 January 2024

Faron Pharmaceuticals Ltd.

 

 

("Faron" or the "Company")

 

 

Inside information: Faron Announces First HMA-failed MDS Patient Dosed with
Bexmarilimab as part of Phase 2 of BEXMAB Trial

 

 

-      Phase 2 of the trial aims to recruit 32 patients with HMA-failed
MDS and to provide final and optimized dosing for registrational study

-      Company is exploring further development opportunities within the
bexmarilimab program in hematological cancer patients following positive
feedback from the recent ASH congress

 

Company Announcement, Inside Information

 

TURKU, Finland / BOSTON, Massachusetts -  January 9, 2024 -  Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage
biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid
cells to activate anti-tumor immunity in hematological and solid tumor
microenvironments, today announced that the first patient has been dosed in
Phase 2 of the BEXMAB trial that evaluates the safety and efficacy of
bexmarilimab, in combination with standard of care (SoC) in patients with
hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome
(MDS), an aggressive myeloid leukemia with very few treatment options.

 

The ongoing, randomized parallel-assigned Phase 2 part is enrolling 32
HMA-failed MDS patients at 3 mg/kg and 6 mg/kg dose levels of bexmarilimab.
Dose levels have been selected in accordance with the FDA's Project Optimus
initiative, which aims to reform the paradigm of dose optimization and
selection in oncology drug development. Patients are being randomized 1:1
between the doses before moving into a Phase 2/3 study expansion. As
previously detailed, data from the first 20 patients (10 per dose group) will
be reviewed for exposure-to-benefit to compare the two selected dose levels.
Post selection of final dosing, Faron intends to discuss a potential
registrational study plan with the FDA.

 

"Dosing of the first patients in this advanced part of the BEXMAB study is
another significant milestone in the bexmarilimab program, and we want to
thank our clinical network again for the rapid advancement of our program,"
said Dr. Birge Berns, Chief Medical Officer of Faron. "Refractory and relapsed
MDS represents a significant therapeutic challenge and based on the recently
announced data at ASH
(https://otp.tools.investis.com/clients/uk/faron2/rns/regulatory-story.aspx?cid=2223&newsid=1741052)
from the Phase 1 part of this trial, we believe that bexmarilimab has the
potential to save and improve the lives of HMA-failed MDS patients."

 

Faron is currently opening additional sites to speed up the trial's rapid
recruitment, ahead of a future registrational study. The Company's key focus
is to pursue an accelerated path to approval in refractory higher risk MDS,
where no treatment option exists.

 

Given the positive results to date, the Company will also explore the
immunotherapy's potential in low risk MDS as well as chronic myelomonocytic
leukaemia (CMML) patients, who are currently treated with HMA-based therapies
treatment upon worsening of disease and consider further development and
expansion opportunities with bexmarilimab in hematological cancers in the form
of partnerships.

 

For more information on BEXMAB, please visit ClinicalTrials.gov
(https://clinicaltrials.gov/) and reference Identifier NCT05428969
(https://clinicaltrials.gov/study/NCT05428969?term=NCT05428969&rank=1) .

 

 

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

 

Media Contact

ICR Consilium

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 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 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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