TIDMFARN
RNS Number : 8917O
Faron Pharmaceuticals Oy
15 June 2022
Faron Pharmaceuticals Ltd
("Faron" or "Company")
Faron Pharmaceuticals Announces Top-Line 12-Month Survival
Results Across 10 Advanced Solid Tumors
-- 65% of patients who benefited from treatment with
bexmarilimab were alive at 12-months compared to 11% for patients
who did not benefit from treatment
-- The strongest survival benefit was seen in checkpoint
refractory melanoma and cholangiocarcinoma where 12 - month
survival was 100% among patients who benefited from bexmarilimab
treatment and 0% for patients who did not benefit from
treatment
-- Analysis includes heavily pre-treated, advanced disease
patients from 10 solid tumor cohorts
-- Treatment with bexmarilimab continues to be well tolerated
with no treatment related adverse events resulting in a decrease or
modification of dosing
Company Announcement, June 15, 2022 at 02:00 AM (EST) / 07:00 AM
(BST) / 09:00 AM (EEST)
Insider information
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 12-month top-line overall survival
results from its Phase I/II MATINS (Macrophage Antibody To INhibit
immune Suppression) study investigating the safety and efficacy of
bexmarilimab monotherapy in ten different hard-to-treat metastatic
or inoperable solid tumor cohorts. The analysis showed that 65%
(11/17) of patients who benefited from treatment with bexmarilimab
( partial response + stable disease rate) were alive at 12-months
compared to 11% (8/73) of patients who did not benefit from
treatment. The strongest survival benefit was seen in checkpoint
refractory melanoma and cholangiocarcinoma where 12-month survival
was 100% among patients who benefited from bexmarilimab treatment
and 0% for patients who did not benefit from treatment. The
analysis includes 90 patients from the trial who received three
courses of treatment and had their scheduled tumor imaging at cycle
four and 12-month survival follow-up completed.
"The updated survival data from the MATINS trial are
significant, especially when you consider the patient population in
this trial," said Daruka Mahadevan, M.D. Ph.D., Chief, Division of
Hematology/Medical Oncology, Mays Cancer Center, University of
Texas Health, San Antonio. "These are heavily pre-treated patients
with significantly advanced disease. It's highly encouraging that
an anti-tumor immune response was activated and that two-thirds of
the patients who benefited from treatment had a durable response
lasting at least 12-months."
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. The most significant clinical benefit rate among the ten
solid tumor 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.
"One-year survival data is an important milestone in any cancer
trial, and we are highly encouraged by the meaningful extension of
life experienced by patients who benefited from bexmarilimab
monotherapy," said Marie-Louise Fjällskog, M.D., Ph.D., Chief
Medical Officer of Faron. "These data, along with the biomarker
data we previously reported, are helping us design our upcoming
registrational trials and further support our belief that
bexmarilimab monotherapy can increase survival in patients with a
variety of late-stage solid tumors ."
The Company will complete a detailed evaluation of the MATINS
data and looks forward to sharing the results at an upcoming
medical conference, as well as with regulatory authorities. Faron
thanks the patients and investigators who are participating in the
MATINS clinical trial. This project has received funding from the
European Union's Horizon 2020 research and innovation programme
under grant agreement No 960914.
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
Faron Pharmaceuticals
Julia Balanova
VP, Investor Relations
julia.balanova@faron.com
investor.relations@faron.com
Phone: +1 (917) 306-6096
Media Contact
Faron Pharmaceuticals
Eric Van Zanten
VP, Communications
eric.vanzanten@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
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 in both solid tumors and hematologic
malignancies. 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 solid tumors and hematologic
malignancies, 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 by 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 .
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCDBGDLUDBDGDS
(END) Dow Jones Newswires
June 15, 2022 02:00 ET (06:00 GMT)
Faron Pharmaceuticals Oy (LSE:FARN)
Historical Stock Chart
From Apr 2024 to May 2024
Faron Pharmaceuticals Oy (LSE:FARN)
Historical Stock Chart
From May 2023 to May 2024