Faron Pharmaceuticals
Ltd.
("Faron"
or the "Company")
Inside Information: Faron
Reports Initial Positive Phase 2 Read-out in HMA-resistant
MDS
Company announcement, Inside
Information, 20 May 2024 at 7:00 a.m. BST / 9:00 a.m.
EEST
Key
highlights
- Initial preliminary phase 2 read-out
from the BEXMAB Trial confirms earlier positive Phase 1 findings in
MDS patients with prior HMA failure
- In
Phases 1 & 2, 14 MDS patients who are refractory or relapsed on
HMA (r/r MDS) and have no effective treatment options, show an
objective response rate (ORR) of 79%
- The
BEXMAB Phase 1 MDS patients with prior HMA failure are experiencing
an estimated median overall survival (mOS) of approximately 13
months currently, compared to the 5-6 months that would typically
be expected under standard of care historically
TURKU, Finland - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pursuing a CLEVER-1
receptor targeting approach to reprogramming myeloid cells to
activate anti-tumor immunity in hematological and solid tumor
microenvironments, today provided first data from patients treated
during the Phase 2 part of the ongoing BEXMAB trial in
myelodysplastic syndrome (MDS) patients that have failed a
hypomethylating agent (HMA), also known as relapsed/refractory MDS
(r/r MDS). There are limited viable treatment options for r/r MDS
and the mOS for these patients is only 5.6 months historically
(Prebet et al. 2011).
The BEXMAB Phase 1 results have
already indicated a high overall response rate (ORR) of 87.5% (7/8)
amongst HMA-failed MDS patients treated with a combination of
bexmarilimab +
azacitidine. There are now a total of 14
HMA-failed MDS patients treated in both Phase 1 & 2 with this
novel combination. The treatment has been well tolerated, without
any dose-limiting toxicity. The ORR in this otherwise
untreatable population is 79% (11/14). The current true remission
rate is 64% (9/14). Similar size patient cohorts treated with
existing alternatives have reported 0-20% ORR, without deep and
durable remissions.
The best responses for these 14
patients are as follows: 1 complete response (CR), 7 marrow
complete remissions (mCR), 1 partial response (PR), 2 hematological
improvements, 2 stable diseases (SD) and 1 progressive disease
(PD). Two patients have moved on to receive bone marrow
transplantation for a possibility of curative treatment. This is
seldom seen in this population because patients usually cannot be
brought to remission. For Phase 1 patients with adequate follow-up
available the estimated mOS is currently 13.4 months, but still
subject to change.
Dr. Amer Zeidan, 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, who is also a leading investigator on the trial,
said: "Management of patients with higher
risk MDS after HMA failure is very challenging and with very
limited options, and is currently considered one of the most urgent
unmet clinical needs in MDS. Bexmarilimab is a promising agent that
works by modulating the immune system and in early data from the
ongoing clinical trial in MDS appears to have a very good safety
profile and promising clinical activity, especially in median
survival after HMA failure. While these are early data and in a
small number of patients, if these findings continue to hold up,
they would position bexmarilimab to potentially fill a
very important clinical gap in the management of MDS
patients".
Dr. Juho Jalkanen, Chief Executive
Officer of Faron, said: "This is a
significant milestone for Faron. Many of us have recognized the
grave need for new treatment options in r/r MDS. With these first
results from the Phase 2 continuing the positive results already
seen in Phase 1, we are committed to rapidly advancing Bexmarilimab
to market, because patients are waiting for treatment options like
this".
Faron will be hosting a virtual
webinar to discuss these data the day after tomorrow, Wednesday,
May 22nd, at 17.00 EEST/15.00 BST
To register for the event
visit:
https://faron.videosync.fi/bexmab-study-update-may2024
or contact the IR team for more information
at investor.relations@faron.com.
For
more information please contact:
Investor Contact
LifeSci Advisors
Daniel Ferry
Managing Director
daniel@lifesciadvisors.com
+1 (617) 430-7576
Media 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 1/2 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.