TIDMFARN
RNS Number : 0759M
Faron Pharmaceuticals Oy
17 September 2021
Faron Pharmaceuticals Ltd.
("Faron")
Faron Announces Presentation of Updated MATINS Data at ESMO
Showing Bexmarilimab Delivers Compelling
Antitumour Activity Across Five Different Advanced Solid
Tumors
-- Strongest dise ase control rate (DCR) observed in five
different tumor types - cutaneous melanoma (30%), gastric cancer
(30%), cholangiocarcinoma (30%), hepatocellular carcinoma (40%) and
breast cancer (40%) patients
-- Landmark analysis estimates overall survival at six months
for DCR (partial response + stable disease rate) patients at 83%
compared to 29% for non-DCR patients
-- Treatment with macrophage-targeting bexmarilimab was well
tolerated with only 7% of treatment related adverse events reported
as grade three or four and 0% reported as grade five
-- Company to host webinar to discuss updated MATINS data on
September 21, 2021 at at 8.30 am EDT / 13.30 pm BST / 15.30 pm
EEST
Company announcement, September 17, 2021 at 02:00 AM (EDT) /
07:00 AM (BST) / 09:00 AM (EEST)
Inside 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 announced updated results from the Phase I/II
MATINS (Macrophage Antibody To INhibit immune Suppression) study
investigating the safety and efficacy of bexmarilimab. The data
will be featured in a Proffered Paper session today at the European
Society for Medical Oncology (ESMO) 2021 Congress (Late Breaking
Abstract Presentation #38, Friday, September 17, 2021; 7:30 am EDT
/ 12:30 pm BST / 2:30 pm EEST).
The updated results from the MATINS study include patients from
Part I (30 patients) and Part II (110 patients) of the trial.
Current estimate for median progression free survival for all these
patients was 59 days (95% confidence interval, 58-61). Estimated
median overall survival (OS) for all patients was 151 days (95%
confidence interval, 118 - 190).
Landmark OS analysis of Part I/II patients who received three
courses of treatment and had their scheduled tumor imaging at cycle
four (n=91) estimated that 83% of patients achieving disease
control rate (DCR) status were alive at six months after the
landmark (approximately 240 days from initiation of treatment)
compared to 29% 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.
"The updated MATINS data provide additional evidence that
bexmarilimab is well tolerated and shows for the first time that
clinical benefit is associated with long term survival in patients
with late-stage solid tumors who have exhausted all standard
treatment options," said Petri Bono, MD, PhD., Chief Medical
Officer, Terveystalo Finland and Principal Investigator of the
MATINS trial. "The efficacy and survival data are particularly
compelling when you consider the late-stage, treatment-refractory
disease patient population and inclusion of nonimmunogenic cold
tumors in the trial."
The 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 first expansion stage (Part II) of the study enrolled
patients across 10 different hard-to-treat solid tumors -
cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+
breast cancer, gastric cancer, hepatocellular carcinoma, ovarian
cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid
carcinoma. Investigator assessed confirmed disease control rate per
RECIST 1.1 at cycle four was 17% across completed part II cohorts.
Treatment with bexmarilimab was well tolerated with only 7% of
treatment related adverse events (TRAEs) reported as grade three or
four and 0% reported as grade five. Additionally, none of the TEAEs
resulted in a decrease or modification of dosing. The most common
TRAEs were fatigue, anemia, abdominal pain and decreased
appetite.
"These updated data strengthen our belief that treatment with
bexmarilimab can increase survival in patients with a variety of
late stage solid tumors," said Dr. Markku Jalkanen, Chief Executive
Officer of Faron. "We look forward to discussing these results with
the FDA and finalizing plans for the Part III expansion cohorts,
which we hope to convert to pivotal stage development for a
regulatory submission. Additionally, all biomarker data are
currently being analyzed for potential patient selection purposes
and we simultaneously continue to advance our plans to investigate
bexmarilimab in additional clinical settings, including neoadjuvant
therapy, in combination with checkpoint inhibitors and as a
treatment for hematological malignancies."
Faron will host a webinar to discuss the updated MATINS data on
Tuesday, September 21, 2021 at 8.30 am EDT, 13.30 pm BST, 15.30 pm
EEST. The webinar will feature a presentation by Jussi Koivunen,
MD, PhD, Medical Director, Oncology at Faron, which will be
followed by a live Q&A session. The event can be accessed at
the "Investors" section on Faron's website at
https://www.faron.com/investors . A replay will be made available
on the investor section of Faron's website shortly after the
event.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014 ("MAR").
For more information please contact:
Media Contact
Faron Pharmaceuticals
Eric Van Zanten
Head of Communications
eric.vanzanten@faron.com
Investor.relations@faron.com
Phone: +1 (610) 529-6219
Investor Contact
Stern Investor Relations
Julie Seidel
julie.seidel@sternir.com
Phone: +1 (212) 362-1200
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. 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 .
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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September 17, 2021 01:59 ET (05:59 GMT)
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