RCS - Faron Pharma. Oy - Presentation of Biomarker Data at AACR 2022

Faron Pharmaceuticals OyAnnouncement

09/03/2022 07:00

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RNS Number : 1102E  Faron Pharmaceuticals Oy  09 March 2022

Faron Pharmaceuticals Ltd

("Faron or Company")

 

Faron Announces Upcoming Presentation of Biomarker Analysis from Patients in
MATINS Trial at AACR Annual Meeting 2022

 

·      Analysis tested performance of baseline cytokine serum IFNy and
TNFa levels to identify patients that experienced disease control following
bexmarilimab treatment compared to those that did not

·      Patients with low baseline IFNy and TNFa levels found to
experience significantly higher clinical benefit following bexmarilimab
treatment

·      Bexmarilimab's unique mode of action could serve as a catalyst
for the immune system allowing initially checkpoint inhibitor resistant
patients to become responsive to PD-1 blockade

 

Press Release, March 9, 2022 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM
(EET)

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Ltd (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company focused on building
the future of immunotherapy by harnessing the power of the immune system to
tackle cancer and inflammation, today announces that an analysis of biomarker
data from patients treated with bexmarilimab as part of the ongoing phase I/II
MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be
presented at the upcoming American Association for Cancer Research (AACR)
Annual Meeting being held in New Orleans, US, from April 8 - 13, 2022. These
data (Abstract #2767) will be featured in the "Biomarkers Predictive of
Therapeutic Benefit" session on Tuesday April 12, 2022 from 9:00 AM - 12:30
PM.

 

Top line data from the biomarker analysis, which was announced by the Company
in December 2021, showed that patients with low baseline levels of serum
interferon gamma (IFNy) and tumor necrosis factor alpha (TNFa) were more
likely to experience clinical benefit following treatment with bexmarilimab,
Faron's wholly-owned investigational precision immunotherapy asset. Data
scheduled for presentation at AACR includes more detailed analysis of 30
patients across three tumor types (advanced gastric cancer, cutaneous melanoma
and cholangiocarcinoma) showing:

 

-       Mean levels of IFNy were 5.11 pg/ml (SD +/- 4.99 pg/ml) in
patients who experienced a clinical benefit versus 13.07 pg/ml

(SD, +/- 13.26) in patients who did not experience a clinical benefit with
bexmarilimab

-       Mean levels of TNFa were 0.96 pg/ml (SD, +/- 0.74 pg/ml) in
patients who experienced a clinical benefit versus 2.37 pg/ml

(SD, +/- 1.43 pg/ml) in patients who did not experience a clinical benefit
with bexmarilimab

 

The conclusion from the analysis is that, when used together, IFNy and TNFa
are highly predictive of response to bexmarilimab (P < 0.0001),
and patients with low IFNy and TNFa levels experienced significantly higher
clinical benefit following treatment with bexmarilimab. Patients with low
levels of pro-inflammatory cytokines experiencing higher clinical benefit is
opposite to what is usually seen with currently approved checkpoint inhibitors
and other T cell activating agents.

 

"Understanding which patients are most likely to benefit from immunotherapy
treatment is key to tackling cancer," said Petri Bono, MD, PhD., Chief Medical
Officer, Terveystalo Finland and Principal Investigator of the MATINS trial.
"This biomarker analysis shows that IFNy and TNFa, which can both be measured
by a standard blood test, perform well in identifying patients likely to
respond to bexmarilimab and could offer the potential to personalize a
patient's therapy and, ultimately, improve their outcome. This is especially
important in earlier treatment line settings and with combination regimens."

 

"This analysis continues to strengthen our understanding of what happens in
the tumor microenvironment when patients are treated with bexmarilimab," said
Dr. Markku Jalkanen, Chief Executive Officer of Faron. "It provides a strong
biological rational to guide our ambitious development program exploring
bexmarilimab's potential as a monotherapy and in combination with other
therapies, only increasing our confidence of the potential impact this novel
macrophage-targeting immunotherapy could have on cancer care. Bexmarilimab's
ability to ignite immune reaction could become a significant new tool to
increase the stagnated response levels of the currently available and widely
used anti-PD-(L)1 treatments."

 

The ongoing open label Phase I/II MATINS clinical trial is investigating the
safety and efficacy of bexmarilimab, Faron's wholly-owned novel precision
cancer immunotherapy targeting Clever-1, a receptor known to be expressed on
immunosuppressive macrophages in the tumor microenvironment. In the MATINS
trial, bexmarilimab is being investigated as a potential monotherapy in
patients with solid tumors who have exhausted all other treatment options.
Landmark overall survival (OS) data presented at the Company's R&D Day in
February from patients in Part I/II of the trial who received three courses of
treatment and had their scheduled tumor imaging at cycle four (n=92) estimated
that 70% of disease control rate (DCR = partial response + stable disease
rate) patients were alive at nine months after the landmark (that is,
approximately 11 months from initiation of treatment) compared to 26% of
non-DCR patients. The most DCR among Part II cohorts was observed in cutaneous
melanoma (30%), gastric cancer (30%), cholangiocarcinoma (30%), hepatocellular
carcinoma (40%) and breast cancer (40%) patients. Treatment with bexmarilimab
continues to be well tolerated with no new safety signals reported and no
treatment related adverse events resulting in a decrease or modification of
dosing.

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com (mailto:eric.vanzanten@faron.com)

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

Phone: +1 (610) 529-6219

 

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

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com (mailto:faron@consilium-comms.com)

Phone: +44 (0)20 3709 5700

 

 

About Bexmarilimab

Bexmarilimab is Faron's wholly-owned, investigative precision immunotherapy
with the potential to provide permanent immune stimulation for
difficult-to-treat cancers through targeting myeloid cell function. A novel
anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive
(Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour
associated macrophages (TAMs) in the tumour microenvironment, converting these
highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages.
In mouse models, bexmarilimab has successfully blocked or silenced Clever-1,
activating antigen presentation and promoting interferon gamma secretion by
leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded
by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and
involved in cancer growth and spread. Observations from clinical studies to
date indicate that Clever-1 has the capacity to control T cell activation
directly, suggesting that the inactivation of Clever-1 as an immune
suppressive molecule could be more broadly applicable and more important than
previously thought. As an immuno-oncology therapy, bexmarilimab has potential
as a single-agent therapy or in combination with other standard treatments
including immune checkpoint molecules. Beyond immuno-oncology, it offers
potential in infectious diseases, vaccine development and more.

 

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a
first-in-human open label phase I/II clinical trial investigating the
tolerability, safety and efficacy of bexmarilimab in ten different
hard-to-treat metastatic or inoperable solid tumour cohorts -
cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer,
gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma,
pancreatic cancer and anaplastic thyroid carcinoma - which are all known to
host a significant number of Clever-1 positive tumour-associated macrophages
(TAMs). The completed Part I of the trial dealt with tolerability, safety and
dose escalation. The ongoing Part II is focused on identifying patients who
show an increased number of Clever-1 positive TAMs and exploring safety and
efficacy. Part III will be focused on assessing efficacy. Data from MATINS
have shown that bexmarilimab has the potential to be the first macrophage
immune checkpoint therapy. To date, the investigational therapy has been shown
to be safe and well-tolerated, making it a low-risk candidate for combination
with existing cancer therapies, and has demonstrated early signs of clinical
benefit in patients who have exhausted all other treatment options.

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical
company developing novel treatments for medical conditions with significant
unmet needs caused by dysfunction of our immune system. The Company currently
has a pipeline based on the receptors involved in regulation of immune
response in oncology, organ damage and bone marrow regeneration. Bexmarilimab,
a novel anti-Clever-1 humanized antibody, is its investigative precision
immunotherapy with the potential to provide permanent immune stimulation for
difficult-to-treat cancers through targeting myeloid function. Currently in
Phase I/II clinical development as a potential therapy for patients with
untreatable solid tumors, bexmarilimab has potential as a single-agent therapy
or in combination with other standard treatments including immune checkpoint
molecules. Traumakine is an investigational intravenous (IV) interferon
beta-1a therapy for the treatment of acute respiratory distress syndrome
(ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is
currently being evaluated in global trials as a potential treatment for
hospitalized patients with COVID-19 and with the 59th Medical Wing of the US
Air Force and the US Department of Defense for the prevention of multiple
organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by
a major trauma.  Faron is based 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 particular, the early data
from initial patients in the MATINS trial may not be replicated in larger
patient numbers and the outcome of clinical trials may not be favourable or
clinical trials over and above those currently planned may be required before
the Company is able to apply for marketing approval for a product.  In
addition,  other factors which could cause actual results to differ
materially include the ability of the Company to successfully licence its
programmes 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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