RCS - Faron Pharma. Oy - MATINS Trial in Cell Reports Medicine

Faron Pharmaceuticals OyAnnouncement

07/12/2023 07:15

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RNS Number : 9506V  Faron Pharmaceuticals Oy  07 December 2023

Faron Pharmaceuticals Ltd.

 

("Faron" or the "Company")

 

Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of
Bexmarilimab in Solid Tumors in Cell Reports Medicine

 

 

-       Bexmarilimab monotherapy shows efficacy in achieving disease
control and prolonged survival in late-stage metastatic solid tumors

-       CLEVER-1 targeting is safe and well-tolerated with no serious
adverse effects

-       Bexmarilimab induced macrophage activation and increased IFNɣ
signaling in patients who achieved disease control and prolonged survival

 

Press release, December 07, 2023

TURKU, Finland / BOSTON, Massachusetts - December 7, 2023 - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage
biopharmaceutical company pioneering macrophage reprogramming for effective
anticancer immunotherapies, today announces the publication of the full safety
and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial
of bexmarilimab in patients with treatment-refractory late-stage solid tumors
in Cell Reports Medicine.

The publication, entitled, "Bexmarilimab-induced macrophage activation leads
to treatment benefit in solid tumors: the phase I/II first-in-human MATINS
trial" is available online at Bexmarilimab-induced macrophage activation leads
to treatment benefit in solid tumors: The phase I/II first-in-human MATINS
trial: Cell Reports Medicine
(https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(23)00501-3)

"Positive Phase 1/2 data published in Cell Reports Medicine highlights
bexmarilimab's potential to overcome cancer immune resistance by restoring
macrophage immune function" said Petri Bono, MD, PhD., Chief Medical Officer,
Terveystalo Finland and Principal Investigator of the MATINS study. "We are
pleased to see that bexmarilimab was safe and very well-tolerated, achieving
disease control and prolonged survival in a proportion of patients with very
late-stage solid tumors who have exhausted all standard treatment options. The
observed stimulation of immune responses including macrophage activation
increased IFNɣ signaling, and improved survival are particularly compelling
given the challenging context of the late-stage, treatment-refractory disease
patient population and the inclusion of nonimmunogenic cold tumors in this
first-in-human trial. These results validate the macrophage-targeted approach
and underscore bexmarilimab's potential as a novel immunotherapy in late-stage
cancers, especially resistant to PD-1 blockade. We look forward to generating
additional data with this novel and innovative macrophage-targeting
immunotherapeutic antibody bexmarilimab."

 

Clever-1 is highly expressed by the most immunosuppressive macrophages and
contributes to impaired antigen presentation and suppression of anti-tumor
immunity. Bexmarilimab is a humanized monoclonal anti-CLEVER-1 antibody that
activates the immune system and evokes anti-tumor responses. The Phase 1/2
first-in-human MATINS trial evaluated the safety and efficacy of CLEVER-1
blockade with bexmarilimab in patients with treatment-refractory solid tumors.
 The monotherapy showed no dose-limiting toxicities and exhibited excellent
safety and tolerability in over 200 patients. Observed disease control rates
were associated with improved survival and were consistent with higher
pre-treatment intratumoral CLEVER-1 levels and low baseline IFNɣ signaling
that then increased during treatment. Transcriptomics profiling of the tumors
demonstrated that bexmarilimab activates intra-tumoral macrophages and
stimulates IFNɣ and T-cell receptors in a proportion of patients, which then
leads to disease control and prolonged survival.

 

For more information on MATINS, please visit ClinicalTrials.gov and reference
Identifier NCT03733990. (https://clinicaltrials.gov/study/NCT03733990)

 

 

 

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 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 and as a monotherapy in last line solid cancers.
Further information is available at www.faron.com
(https://eur01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.faron.com%2F&data=05%7C01%7C%7Ca4ae0afa96854c5c5f2a08db771ae20d%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638234729855975666%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2FNadoN9wXIGZtfCkFVuLSTXPpNg3%2BBXoRfIQaIPce6k%3D&reserved=0)
.

 

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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