REG - Faron Pharma. Oy - Faron Announces Positive BEXMAB Study Update

Faron Pharmaceuticals OyAnnouncement

11/10/2023 07:15

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RNS Number : 7025P  Faron Pharmaceuticals Oy  11 October 2023

Faron Pharmaceuticals Ltd.

("Faron" or the "Company")

 

Inside information: Faron Announces Positive BEXMAB Study Update in
Relapsed/Refractory AML and HMA-Refractory MDS Patients

 

·    Bexmarilimab produces a 50% remission rate in doublet dose cohorts
(11 out of 22 patients)

·    Eight of the 11 patients are Complete Responders (CR) or CR with
incomplete blood recovery (CRi)

·    Highest overall response rate (ORR) of 80% observed in prior
HMA-failure MDS group (4 out of 5 patients)

·    Bexmarilimab continues to be well-tolerated with no dose-limiting
toxicity observed

·    Company to host virtual investor call to discuss data, today at 8:00
am EST

 

Company announcement, Inside Information

TURKU, Finland / BOSTON, Massachusetts - October 11, 2023 - Faron
Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage
biopharmaceutical company pioneering macrophage reprogramming for effective
anticancer immunotherapies, today announces updated data from the Phase 1/2
BEXMAB study investigating bexmarilimab in combination with standard of care
(SoC) in relapsed/refractory (r/r) acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS) patients having failed hypomethylating agents
(HMAs).

The updated data are consistent with the high objective response rate observed
in the previous results. The most recent data includes read outs from a total
of 22 patients (r/r AML with 12 patients, MDS frontline and MDS HMA-failed
patients with five patients each) who have completed at least two or more
treatment cycles. Eight of 11 patients achieved complete remission in the bone
marrow with or without blood count recovery.

The highest single indication-specific ORR was observed among HMA-failed MDS
patients (4 out of 5 patients; 80%). The combined study ORR continues to be
high (11 out of 22 patients; 50%) across all patient groups having received
two or more treatment cycles in the doublet. In most patients (75%), blast
reduction was observed. A total of 29 patients have been recruited into the
doublet cohort as of October 5, 2023.

Bexmarilimab continues to be well-tolerated at all tested dose levels as no
dose-limiting toxicity has been observed. A total of 18 drug-related events
were observed with the majority below Grade 3. Five drug-related events were
reported as Grade 3 and above, including immune-related events (capillary leak
syndrome, hemophagocytic lymphohistiocytosis and cryptogenic organizing
pneumonia), as well as one event of increased liver enzymes.

"The emerging data from Phase 1/2 continue to be extremely promising, showing
continued good safety, encouraging efficacy and long durations of response,"
said Dr. Markku Jalkanen, Chief Executive Officer of Faron. "These results
strongly support the planned next step of beginning enrollment of the Phase 2
part of the BEXMAB study."

Dr. Jalkanen continued: "We believe that bexmarilimab has the potential to
provide better patient outcomes and improve the quality of life of those
suffering from relapsed/refractory AML and MDS, which are conditions with dire
prognosis and limited new therapies in the last decades."

 

Faron plans to initiate the Phase 2 part of the BEXMAB study in HMA-failed MDS
and r/r AML patients in Q4 2023. Consistent with the FDA's Project Optimus
initiative, the planned Phase 2 will start with dose optimization and is
expected to enroll 28-32 patients randomized between two selected doses. Faron
plans to increase the number of US clinical sites from two to five sites to
accelerate study recruitment. For more information on BEXMAB, please visit
ClinicalTrials.gov and reference Identifier NCT05428969.

 

Faron will host a virtual call for investors to discuss the data today at
08.00 EST/13.00 BST/15.00 EEST. There will also be an opportunity to ask
questions during the webcast. To register for the webcast, please visit:
https://faron.videosync.fi/recent-bexmab-results-and-future-outlook-event
(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ffaron.videosync.fi%2Frecent-bexmab-results-and-future-outlook-event&data=05%7C01%7C%7C06498ad92946441ad04108dbc31bc386%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638318296240716008%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=vAsvM1pDQ14neLbTGJxn0zpkaIWG68JrtI1z%2BErBG5E%3D&reserved=0)
or contact the IR team for more information at investor.relations@faron.com.
(mailto:investor.relations@faron.com)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) No 596/2014 ("MAR").

 

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

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com (mailto:Jennifer.Smith-Parker@faron.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 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 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
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 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 targeting 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
(https://eur01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.faron.com%2F&data=05%7C01%7C%7Ca4ae0afa96854c5c5f2a08db771ae20d%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638234729855975666%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2FNadoN9wXIGZtfCkFVuLSTXPpNg3%2BBXoRfIQaIPce6k%3D&reserved=0)
.

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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