REG - Faron Pharma. Oy - Additional Positive Data from Phase 1 of BEXMAB

Faron Pharmaceuticals OyAnnouncement

18/03/2024 07:00

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RNS Number : 1453H  Faron Pharmaceuticals Oy  18 March 2024

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/
(https://faron.videosync.fi/bexmab-study-update/) or contact the IR team for
more information at investor.relations@faron.com
(mailto:investor.relations@faron.com) .

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com (mailto: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 (mailto: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
(http://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.

 

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