RCS - Faron Pharma. Oy - Bexmarilimab Efficacy and Safety in MATINS Trial

Faron Pharmaceuticals OyAnnouncement

24/04/2023 07:15

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RNS Number : 1380X  Faron Pharmaceuticals Oy  24 April 2023

Faron Pharmaceuticals Oy

 

("Faron or the Company")

 

Faron Announces Release of Research Confirming Bexmarilimab Efficacy and
Safety in MATINS Trial

 

·    Macrophage targeting can promote tumor stabilization in late-stage
cancer

·    Bexmarilimab-induced macrophage activation with robust stimulation of
IFN-γ and T-cell receptor signaling only in patients with disease control

·    Data confirms that bexmarilimab therapy is well-tolerated

 

Press Release, April 24, 2023

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company focused on tackling
cancers via novel immunotherapies, today announces the release of further
insights from its Phase I/II MATINS study, validating the efficacy and safety
of the Company's wholly owned immunotherapy, bexmarilimab, in solid tumors.

 

The manuscript, which is available here
(https://www.medrxiv.org/content/10.1101/2023.04.17.23288693v1) , indicates
that macrophage conversion, and changes in the tumor microenvironment leading
to disease control and prolonged survival in late-stage cancer, is achieved
with bexmarilimab monotherapy, and that targeting CLEVER-1 with bexmarilimab
is well-tolerated. CLEVER-1 is an immunosuppressive receptor on macrophages
leading to tumor growth and metastases.

 

Bexmarilimab is a humanized anti-CLEVER-1 antibody that primes the immune
system to attack tumors.

 

In addition to these findings, the manuscript indicates that low baseline
immune activation is associated with bexmarilimab which converts intratumoral
macrophages to support adaptive immune responses.

 

"We are very pleased to see that bexmarilimab is well-tolerated and has
promising antitumor activity as a single agent in late-stage solid tumors,"
said Chief Scientific Officer Dr. Maija Hollmén. "This manuscript brings
together clinical safety and efficacy data with in-depth analyses of tumor
biopsies and systemic inflammatory responses. Excitingly, it reinforces the
evidence that macrophage conversion in the tumor takes place after
bexmarilimab administration and coincides with treatment benefit."

For more information please contact:
 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com (mailto:Jennifer.Smith-Parker@faron.com)

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com (mailto:julia.balanova@faron.com)

investor.relations@faron.com (mailto:investor.relations@faron.com)

Phone: +1 (917) 306-6096

 

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

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Renna Foufouni

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron's wholly owned, investigational immunotherapy with the
potential to provide immune stimulation for treatment-resistant cancers
through targeting myeloid cell function. A novel anti-CLEVER-1 humanized
antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial
and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in
the tumor microenvironment, converting highly immunosuppressive M2 macrophages
to immune-stimulating M1 macrophages. As an immuno-oncology therapy,
bexmarilimab has therapeutic potential in combination with other standard
treatments including immune checkpoint molecules in both solid tumors and
hematologic malignancies.

 

About MATINS

MATINS has demonstrated a positive safety profile in more than 200 patients
treated with bexmarilimab. The study has observed an approximate 30% clinical
benefit rate in several tumor types, which is associated with an interferon
gamma (IFN-y) increase and leads to a significant survival benefit. Moreover,
responding patients can be potentially identified using baseline IFN-y or
CLEVER-1 expression. CLEVER-1 is a novel immune checkpoint, a receptor shown
to promote an immunosuppressive environment.

 

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its
subsidiaries, is a clinical stage biopharmaceutical group focused on building
the future of immunotherapy by harnessing the power of the immune system to
tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its
investigational immunotherapy 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 and solid cancers in combination with other standard
treatments including immune checkpoint molecules. Faron is headquartered in
Turku, Finland. 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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