REG - Faron Pharma. Oy - Faron Updates on Bexmarilimab Development Program

Faron Pharmaceuticals OyAnnouncement

23/02/2022 07:00

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RNS Number : 4811C  Faron Pharmaceuticals Oy  23 February 2022

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

 

Faron Provides Update on Bexmarilimab Development Program Ahead of R&D Day

·      Updated landmark analysis estimates nine-month overall survival
rates were 70% for heavily pre-treated, late-stage cancer patients who
benefited from treatment with bexmarilimab and 26% for patients who did not
benefit from treatment

·      Biomarker analysis showed widely available blood tests can
identity which patients are likely to receive clinical benefit from treatment
with bexmarilimab

·      Treatment with bexmarilimab continues to be well tolerated with
no treatment related adverse events resulting in a decrease or modification of
dosing

·      Company to host virtual R&D Day webcast today, Wednesday,
February 23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT

 

Company announcement, February 23, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) /
02:00 AM (EDT)

 

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 updated survival data from
Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study
investigating the safety and efficacy of bexmarilimab. The data will be
presented at the Company's virtual R&D Day webcast today, Wednesday,
February 23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT. To register for Faron's
R&D Day webcast, please visit:  https://faron.videosync.fi/r-and-d-day
(https://faron.videosync.fi/r-and-d-day) .

 

The updated results from the MATINS study include patients from Part I (30
patients) and Part II (110 patients) of the trial. For all these patients, the
estimated median progression free survival (PFS) is 59 days (95% confidence
interval, 58-61). The estimated median overall survival (OS) is 157 days (95%
confidence interval, 128-192).

 

Landmark OS for Part I/II patients 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
significant disease control rate (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.

 

As previously announced, patients with low interferon gamma (IFNy) and tumor
necrosis factor alpha (TNFa) levels experienced significantly higher clinical
benefit following treatment with bexmarilimab. This is the opposite to what
is usually seen with checkpoint inhibitors and other T cell activating agents.
Additionally, a more than 100% increase in IFNy levels was seen after the
first cycle of bexmarilimab treatment among patients who experienced clinical
benefit.

 

As part of an ongoing biomarker analysis, receiver operating
characteristic (ROC) curves found that low levels of both IFNy and TNFa was
highly predictive of clinical benefit (AUC 0.83, P < 0.0001). Likelihood of
clinical benefit increased even higher (AUC 0.9107, P < 0.0001) when low
levels of IL-6 & IL-8 were also present. These four inflammatory
biomarkers can easily be identified by simple, inexpensive and readily
available blood tests. The ability to have these classical pro-inflammatory
cytokines measured as part of a patient's routine clinical care could expedite
treatment decisions improving patient care, which today requires costly
biopsies and pathology tests.

 

"The updated MATINS data shows even more clearly that heavily pre-treated,
late-stage cancer patients who receive clinical benefit from bexmarilimab can
achieve long term survival," said Marie-Louise Fjällskog, M.D., Ph.D., Chief
Medical Officer of Faron. "The ongoing biomarker analysis is also helping us
better identify which patients are likely to respond and what happens in the
tumor microenvironment when patients are treated with bexmarilimab."

 

The Company will host a virtual R&D Day webcast today, Wednesday, February
23, at 4:00 pm EET, 2:00 pm GMT, 9:00 am EDT. To register to participate in
the virtual webcast, please visit:  https://faron.videosync.fi/r-and-d-day
(https://faron.videosync.fi/r-and-d-day) .

Dr. Markku Jalkanen, Chief Executive Officer of Faron, will host the event
together with members of Faron's Global Leadership Team. In addition, the
following external experts will provide additional perspectives on the
immunotherapy treatment landscape and how bexmarilimab may help address the
significant unmet medical need that continues to exist:

·      Dr. Tyler Curiel, Professor of Medicine and Microbiology,
Immunology & Molecular Genetics at The University of Texas Health Science
Center at San Antonio, United States

·      Dr. Maija Hollmén, Adjunct Professor of Tumour Immunology, Group
Leader and Academy Research Fellow at the MediCity Research Laboratory,
Institute of Biomedicine, University of Turku, Finland

 

"I look forward to hosting our virtual R&D Day and providing an update on
the current treatment landscape and what we are doing to help address the
significant unmet medical needs of cancer patients," said Dr. Markku Jalkanen,
Chief Executive Officer of Faron. "Our accelerated bexmarilimab development
plan, which in addition to the ongoing MATINS trial includes plans to study
bexmarilimab in combination with other checkpoint inhibitors and as a
treatment for hematological malignancies, is ambitious, but given the data we
have seen to date and our evolving understanding of which biomarkers will
predict response to treatment, we are confident that we can progress each of
these programs forward and potentially have an extremely broad impact on
cancer care."

 

A Finnish language interview with Dr. Markku Jalkanen covering the important
information shared during the R&D Day event will also take place on
February 23, 2022. A link to a recording of this interview will be made
available on the "Investors" section on Faron's website at:
 https://www.faron.com/investors (https://www.faron.com/investors) .

 

 

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

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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