REG - Faron Pharma. Oy - BEXMAB study update

Faron Pharmaceuticals OyAnnouncement

17/04/2023 07:00

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RNS Number : 3461W  Faron Pharmaceuticals Oy  17 April 2023

Faron Pharmaceuticals Oy

 

("Faron" or the "Company")

 

Inside Information: Encouraging Additional Data for Bexmarilimab for the
Treatment of Hematological Malignancies

 

BEXMAB Study Update

 

·    Two objective responses (ORR) and two stable disease (SD) patients,
with one having > 50% reduction of blast cells, observed in the second
doublet cohort

·    Of the three patients with ORR in the first doublet cohort, two
remain on the study after 10 and 9 months, respectively, and the third has
undergone a potentially curative transplantation

·    Second dose level in doublet well-tolerated and third cohort open for
enrolment

·    First dose level in triplet well tolerated and second cohort open for
enrollment

·    Plans to initiate the study's Phase II in H2 2023

 

Company announcement, April 17, 2023

Inside information

 

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company focused on tackling
cancers via novel immunotherapies, today announces additional positive data
from the Company's Phase I/II BEXMAB study. BEXMAB is investigating
bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with
standard of care (SoC) in relapsed/refractory acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS).

 

The responses from these patients are further defined as:

 

·    In the second doublet cohort (3mg/kg + azacytidine), two patients
have objective responses thus far, including one complete response with
incomplete blood count recovery (CRi) and one patient with hematological
improvement in platelets (HI-P). There are two patients with SD, of which one
has > 50% reduction in bone marrow blasts, and one patient with progressive
disease.

·    The first doublet cohort (1mg/kg + azacytidine) has seen a complete
response with incomplete hematological recovery (CRi) in a patient with
relapsed/refractory AML. The patient is still responding after 10 months.
Another patient with MDS that experienced CR is still in remission after 9
months. An additional patient that achieved a partial response has undergone a
possibly curative allogenic stem cell transplantation.

·    No bexmarilimab-related Grade 3 or higher adverse events (AEs) or
serious adverse events (SAEs) observed in the second dosing cohort and
enrolment into the third cohort (6mg/kg) ongoing.

·    The first triplet cohort (1mg/kg + azacytidine + venetoclax) was
well-tolerated and the second cohort (3mg/kg + azacytidine + venetoclax) has
opened for enrollment.

·    Additional efficacy read-outs for all cohorts expected in the
upcoming months.

·    On a potential path to a Biologics License Application (BLA)
submission, the Company plans to seek FDA advice during Q3 2023.

 

"We are extremely encouraged by the continued efficacy of bexmarilimab and the
long duration of the responses seen so far," said Chief Medical Officer
Marie-Louise Fjällskog. Dr. Fjällskog noted the success of the MDS patient
who did not respond to previous azacytidine therapy, but with the addition of
bexmarilimab, the patient is undergoing potentially curative transplantation.

 

The primary objective of the BEXMAB study (ClinicalTrials.gov:
(https://www.clinicaltrials.gov/) NCT05428969) is to determine the safety and
tolerability of bexmarilimab in combination with SoC (azacytidine and
venetoclax) treatment and to identify the recommended Phase II dose. Secondary
objectives include characterizing preliminary efficacy as well as
bexmarilimab's pharmacokinetic profile in combination with SoC treatment and
assessing its immunogenicity.

 

In January 2023, the Company announced objective responses in 3 out of 5
patients dosed in the first doublet cohort of the BEXMAB study. The Company
also announced enrollment updates for the study's cohorts, and that it had
opened the first triplet cohort with bexmarilimab, azacytidine and venetoclax
in newly diagnosed AML patients who are unable to tolerate chemotherapy.

 

"The latest data are a powerful indication of the therapeutic potential for
bexmarilimab in hematological malignancies," said CEO Dr. Markku Jalkanen.

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

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com (mailto:Jennifer.Smith-Parker@faron.com)

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com (mailto:julia.balanova@faron.com)

investor.relations@faron.com (mailto:investor.relations@faron.com)

Phone: +1 (917) 306-6096

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com (mailto:faron@consilium-comms.com)

Phone: +44 (0)20 3709 5700

 

About Bexmarilimab

Bexmarilimab is Faron's wholly owned, investigational immunotherapy with the
potential to provide immune stimulation for treatment-resistant cancers
through targeting myeloid cell function. A novel anti-CLEVER-1 humanized
antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial
and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in
the tumor microenvironment, converting highly immunosuppressive M2 macrophages
to immune-stimulating M1 macrophages. As an immuno-oncology therapy,
bexmarilimab has therapeutic potential in combination with other standard
treatments including immune checkpoint molecules in both solid tumors and
hematologic malignancies.

 

About BEXMAB

The BEXMAB study is a first-in-human, 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 (azacytidine)
treatment and to identify the recommended Phase II dose. 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 Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its
subsidiaries, is a clinical stage biopharmaceutical group focused on building
the future of immunotherapy by harnessing the power of the immune system to
tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its
investigational immunotherapy with the potential to remove immunosuppression
of cancers through targeting myeloid cell function. Bexmarilimab is being
investigated in Phase I/II clinical trials as a potential therapy for patients
with hematological and solid cancers in combination with other standard
treatments including immune checkpoint molecules. Faron is headquartered in
Turku, Finland. 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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