Faron Pharmaceuticals
Ltd.
("Faron"
or "the Company")
Faron's Capital Markets
Day 2024 - BEXMAB follow-up data and update on drug development
pipeline, partnering discussions and introducing new Scientific
Advisory Board
Company Announcement, 22 October 2024
TURKU, FINLAND - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company
focused on tackling cancers via novel
immunotherapies, will host a
Capital Markets Day for investors, analysts and media today,
Tuesday, 22 October 2024 at 08:00 am (EDT) / 13:00 pm (BST) / 15:00
pm (EEST). Speakers are Dr. Mika Kontro, MD, PhD, Associate
Professor at the University of Helsinki, Mr. Ralph Hughes,
MSc, BSc, Senior Vice President at PharmaVentures and Faron's
senior management members.
BEXMAB Follow Up Data Continue to Indicate High
Overall Response Rate
The BEXMAB Phase I/II trial results
have already indicated a high overall response rate (ORR) of 79%
(11 out 14) amongst relapsed and refractory myelodysplastic syndrome (r/r MDS)
patients treated with a combination of bexmarilimab + azacitidine.
Similar size patient cohorts treated with existing alternatives
have reported 0-20% ORR, without deep and durable
remissions.
Previously estimated median overall
survival (mOS) was approximately 13.4 months with 14 r/r MDS
patients and subject to change with longer follow up. Now, after
median follow up of 275 days (doubled since May 2024),
the mOS among these 14 r/r MDS patients
remains strong at 13.4 months, which is significantly longer than
the 5-6 months typically expected with standard care, as reported
in the literature. Median time on treatment
for r/r MDS in the BEXMAB trial at the moment is 7.9 months,
exceeding any prior expectations in this field. The treatment
remains well tolerated according to the latest safety follow
up.
Previously there were two (2/14)
patients who moved on to receive bone marrow transplant and there
are now a total of three patients (3/14) who have moved to bone
marrow transplant which is seen as the only possibility for
curative treatment of r/r MDS.
Business Update / Partnering Discussions
In June
2024, Faron completed a fully subscribed EUR 30.7 million share
offering and published its focus areas for 2024:
1. To obtain
regulatory feedback from the USA Food and
Drug Administration (FDA) regarding
measures required to obtain regulatory approval in the
U.S.
2. Aim to complete
BEXMAB Phase II enrolment.
3. Aim to conclude
a global partnership deal to fund Phase III clinical research and
to commercialize bexmarilimab.
4.
To have sufficient funding until the latter half
of March 2025, allowing the Company to pursue readiness to move to
Phase III in drug development, and in compliance with the financial
covenants of the IPF Fund II SCA, SICAV-FIAR's Facilities
Agreement.
In July, Faron obtained positive
feedback from the FDA regarding the registrational study plan for
bexmarilimab in relapsed
and refractory high risk MDS (HR MDS). In August 2024, the FDA
granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r
MDS. Based on the FDA's guidance, Faron
made the decision to recruit additional frontline MDS patients.
Full BEXMAB enrolment will include 32 r/r MDS patients and also 20
frontline HR MDS patients. According to the latest enrolment
estimate, the BEXMAB trial (including also 20 frontline HR MDS
patients) will be fully recruited in January 2025.
Since the fundraise completed in
June 2024, Faron has been in dialogue with several partner
candidates to fund Phase III development and to commercialize
bexmarilimab. These
discussions have progressed according to Faron's expectations. To
date, the Company has chosen not yet to enter into a partnership
agreement or grant exclusivity to any negotiating party. Faron
continues to discuss and evaluate the received terms and their
impact diligently. To enable more
flexibility in pursuing the best commercial outcome for the Company
and its shareholders in continued compliance with the financial
covenants and to facilitate availability of high-quality Phase II
BEXMAB efficacy data (also observing patient enrolment for full
Phase II readout), Faron may, subject to market conditions,
consider strengthening its financial position before concluding
discussions concerning partnering.
Scientific Advisory Board Renewed
Faron has renewed its Scientific
Advisory Board (SAB) to better correspond with the Company's
current drug development pipeline. The new Scientific Advisory
Board consists of prestigious and internationally recognized
clinical scientists with broad anti-cancer clinical development
expertise within haematological neoplasms and solid tumors. The SAB
will assist Faron's management in making significant scientific
judgements related to translational activities as well as its
clinical portfolio. The members of Faron's SAB are Dr. Toni
Choueiri, Dr. Tom Powles, Dr. Amer Zeidan, Dr. Naval G. Daver, Dr.
Mika Kontro and Dr. Christophe Massard.
Toni Choueiri, MD is the Jerome
and Nancy Kohlberg Chair and Professor of Medicine at Harvard
Medical School, Boston, MA, the Director of the Lank Center for
Genitourinary (GU) Oncology and co-leader of the Kidney Cancer
Program at Dana-Farber/Harvard Cancer Center. He serves on the US
National comprehensive cancer network (NCCN) expert panel. He has
over 800 PubMed-indexed publications and is the lead investigator
in multiple international phase 1-3 clinical trials in
genitourinary cancers. In a series of NEJM articles on which Dr
Choueiri was either first or last author, he has made seminal
observations leading to multiple FDA and EMA approvals.
Tom
Powles, MBBS, MRCP, MD is a
professor of urology cancer at the University of London and the
Director of Barts Cancer Centre which is one of the UKs largest
Cancer Centres. Prof Powles is also editor-in-chief of Annals of
Oncology, the leading European oncology scientific journal. He has
had a major role in the development of biomarkers and new drug
strategies leading to multiple FDA and EMA approvals. He has
authored 10 NEJM or Lancet publications with two first author NEJM
publications and two first author Nature publications. He was named
in December 2023 in TIME's list among the most influential people
in global health.
Amer Zeidan, MD, MBBS, MHS is
an Associate Professor of Medicine, Chief of Hematologic
Malignancies Division, Director of Hematology Early Therapeutics
Research, and leader of the clinical program and the Clinical
Research Team for Leukemia and Myeloid Malignancies at Yale Cancer
Center. Dr. Zeidan specializes in the management of
myeloid malignancies especially MDS and acute myeloid leukemia
(AML). His research and clinical care focus on targeting therapies
to a patient's diagnosis and working with their own immune system
to counter the malignancies. He has published over 330
peer-reviewed publications and is the
principal investigator on numerous phase II and III clinical trials
in the areas of acute myeloid leukemia and myelodysplastic
syndromes.
Naval G. Daver, MD is a
Professor and Director of the Leukemia Research Alliance Program in
the Department of Leukemia at MD Anderson Cancer Center (MDACC) in
Houston, TX. He is a clinical investigator with a focus on
molecular and immune therapies in acute myeloid leukemia (AML)
and myeloid disease and is principal investigator on more than 25
ongoing institutional, national, and international clinical trials
in these diseases, including multiple registration and label
enabling trials. Prof. Daver has published over 400 peer-reviewed
manuscripts and is on the editorial board of numerous hemalotology
journals.
Mika Kontro, MD, PhD is an
adjunct professor and a consultant in clinical hematology at the
Helsinki University Hospital Comprehensive Cancer Center. Dr. Mika
currently works as K. Albin Johannson Cancer Research Fellow
(Finnish Cancer Institute) and as a group leader in Finnish
Institute of molecular medicine, FIMM. He has a strong background
in running clinical trials and he currently chairs the Finnish AML
group and is a board member of the Nordic AML Group.
Christophe Massard, MD, PhD is
professor and a Head of Cancer Research at Gustave-Roussy, the
first leading cancer hospital in Europe and in the top four in the
world. Dr. Christophe is a member of ESMO, ASCO and AACR and
has participated in over 130 trials in the past five years. He has
been the principal investigator over the last 10 years of 50 phase
1 trials and co-investigator in more than 100 trialsHis research
focuses on early clinical trials and precision medicine. He has
published over 100 peer-reviewed publications.
Development Plan for Solid Tumors
Progressing
Faron has made significant progress
with its development plan regarding bexmarilimab's future potential in
treating solid tumors. In today's CMD, Faron will present its
oncology pipeline for solid tumors to illustrate bexmarilimab's potential as a
first-in-class macrophage reprogrammer in various anti-cancer
treatments. In addition, an update on the innovative approaches in
improving recognition of tumor cells and preventing
immunosuppression will be presented.
Dr.
Juho Jalkanen, CEO of Faron, comments:
"As previously communicated,
everything is progressing as planned and our focus is to ensure
that we are armed with adequate resources to be able to meet our
objectives of completing Phase II of the BEXMAB trial and
optimizing the outcome of partnering with Phase II data. The
next business decision we make will be crucial in how
the value and future of bexmarilimab is divided. There is more
than two decades of hard work behind the development of
bexmarilimab, and our job
is to see that the maximum potential of bexmarilimab comes to life for both
patients and investors."
Dr. Petri Bono, CMO of Faron,
comments:
"We've continued to see extremely
encouraging data from our ongoing BEXMAB trial, and I am very
pleased to see that the data encourage us systematically as we go
forward in our solid tumor development pipeline. Our purpose is to
establish bexmarilimab as
a cornerstone drug for cancers where Clever-1 macrophages are a
source of treatment resistance and cancer progression. Now we've a
world-leading Scientific Advisory Board supporting us, the likes of
which I have never seen before, and I am very excited about what
future holds."
Presentation Materials and Webcast
The Capital Markets Day presentation
material will be available at https://www.faron.com/investors.
The CMD webcast can be followed online at
https://faron.videosync.fi/cmd-2024
For
more information please contact:
ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.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 BEXMAB
The BEXMAB study is an open-label
Phase I/II clinical trial investigating bexmarilimab in combination with
standard of care (SoC) in the aggressive hematological malignancies
of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
The primary objective is to determine the safety and tolerability
of bexmarilimab in
combination with SoC (azacitidine) treatment. Directly targeting
Clever-1 could limit the replication capacity of cancer cells,
increase antigen presentation, ignite an immune response, and allow
current treatments to be more effective. Clever-1 is highly
expressed in both AML and MDS and associated with therapy
resistance, limited T cell activation and poor outcomes.
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 reprogramming 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. 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 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.