Faron Pharmaceuticals
Ltd.
("Faron"
or the "Company")
Inside
Information: Additional Positive Data from
the Phase 1 Part of the BEXMAB Study in Both
Higher-Risk HMA-Failed MDS and r/r
AML
Company announcement, 18 March 2024 at 7:00 a.m. GMT / 9:00
a.m. EET
Key
highlights
- Latest readout of the BEXMAB study shows more responding
patients and good durability of remission amongst HR HMA-failed MDS
patients.
- 4/5 of the initial Phase 1 HR HMA-failed MDS patients were
still alive after eight months of follow-up.
- While data do not yet allow the precise estimation of median
overall survival, the survival benefit seen with the current
follow-up already for these 5 first patients is very
encouraging. This compares favorably to what has been seen with
contemporary comparators.
- 3 additional HMA-failed HR MDS patients have been enrolled in
Phase 1 part, leading to a total of 7 out of 8 patients responding,
an overall response rate of 87.5%.
- Faron will be hosting a virtual webinar to discuss the
additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am
GMT.
TURKU, Finland / BOSTON, Massachusetts
- Faron Pharmaceuticals Ltd. (AIM: FARN, First
North: FARON), a clinical-stage biopharmaceutical company pursuing
a CLEVER approach to reprogramming myeloid cells to activate
anti-tumor immunity in hematological and solid tumor
microenvironments, today provided further data from patients
treated during the Phase 1 part of the ongoing BEXMAB trial that
has moved into Phase 2 for higher-risk (HR) myelodysplastic
syndrome (MDS) patients failed on previous hypomethylating agent
(HMA).
Previous BEXMAB study results
indicated a high overall response rate (ORR) of 5/5 amongst HR
HMA-failed MDS patients, for whom there is no approved
treatment. The majority of the initial
Phase 1 patients have now been on treatment with bexmarilimab together with azacitidine
for more than six months, and only one patient has been lost due to
transformation of their HR MDS into acute myeloid leukemia (AML).
Out of these initial 5 patients, 4 remain alive after eight months.
Normally, patients with relapsed or refractory HR MDS have a median
overall survival (mOS) of fewer than six months. The mOS of
patients treated in the BEXMAB trial is not yet available but,
based on the current data, it is estimated to be significantly
higher than traditionally seen with current standard of care (or
with current approved treatments).
After the already reported 5
HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were
enrolled, filling the remaining Phase 1 slots. Whilst it is too
early to assess these patients for survival or durability, the
previously seen high ORR has been corroborated with 2/3 responders.
The third patient dropped out of the study early in cycle two due
to an unrelated serious adverse event (SAE), bringing the current
ORR to 7/8 patients (87.5%) in the HMA-failed HR MDS population.
The best responses for these 8 patients are as follows: 1 complete
response (CR), 3 marrow complete remissions (mCR), 1 partial
response (PR), 2 hematological improvements, and 1 stable disease
(SD) that dropped out early due to an unrelated SAE.
Mika Kontro, MD, PhD, Associate
Professor at the Helsinki University Hospital Comprehensive Cancer
Center and Principal Investigator of the BEXMAB trial, said: "We
are continuing to see encouraging data from the BEXMAB trial with
usually unresponsive patients going into remission after treatment
with bexmarilimab and
azacitidine. Whilst we don't have median overall survival rates
yet, it is encouraging to see that some patients are alive and,
importantly, enjoying a good quality of life even up to 12+ months
after treatment initiation. I continue to be very excited about the
potential of bexmarilimab to considerably
improve outcomes for patients suffering from these aggressive
conditions."
Dr. Markku Jalkanen, Chief Executive
Officer of Faron, said: "These data are
really remarkable and confirm our belief that we may finally have a
treatment for this underserved patient population. The data are
strongly supportive that a registrational trial would be positive
against any contemporary comparator when the final endpoint is
survival. We eagerly await completion of the Phase 2 part of the
BEXMAB study so we can take these data to the FDA as soon as
possible."
For the 5 frontline HR MDS patients
with 100% ORR previously reported at the American Society of
Hematology (ASH) Annual Meeting last year, mOS has also not yet
been reached. For the r/r AML patient cohort reported at ASH, which
is bigger in size (n= 18) and more mature in follow-up (median
follow-up six months), the mOS is currently estimated to be over 8
months (still subject to change as some patients are still
ongoing). The historical mOS for this population is around six
months, which means that the current data would support running a
registrational trial with mOS also as the endpoint in this
population.
Faron will be hosting a virtual
webinar to discuss these data tomorrow, Tuesday, 19 March, at 11.00
EET/9am GMT.
There will be an opportunity to ask
questions during the webcast. To register for the event
visit: https://faron.videosync.fi/bexmab-study-update/
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
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historical facts but rather on the Directors' current expectations
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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.
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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
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reliance on forward-looking statements. Subject to any continuing
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undertake any obligation to publicly update or revise any of the
forward-looking statements or to advise of any change in events,
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