REG - Faron Pharma. Oy - BEXMAB study update

Faron Pharmaceuticals OyAnnouncement

19/07/2023 07:00

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RNS Number : 4360G  Faron Pharmaceuticals Oy  19 July 2023

Faron Pharmaceuticals Ltd.

("Faron" or "the Company")

 

 Inside Information:  Faron Updates Positive Clinical Data from Phase I/II
BEXMAB Study of Bexmarilimab in Relapsed/Refractory AML and MDS

BEXMAB Study Update

 

·    Three of five patients in the 6 mg/kg bexmarilimab + azacitidine
doublet cohort achieved objective responses (CR and mCR)

·    Eight of 15 objective responses observed in all three doublet dosing
cohorts

·    One patient has stayed on treatment for 13 months

·    Updated BEXMAB data supports advancement to Phase II in H2 2023
focusing on SoC relapsed/refractory AML and MDS patients failing
hypomethylating agents (HMA)

·    Filing of first Biologics License Application (BLA) to FDA planned
for H1 2025

·    Company management team will host a conference call and webcast to
discuss the data today at 8:30 am ET

 

Company Announcement, July 19, 2023

 

Inside Information

 

TURKU, Finland / BOSTON, Massachusetts - Faron Pharmaceuticals Ltd. (AIM:
FARN, First North: FARON), a clinical-stage biopharmaceutical company focused
on tackling cancers via novel immunotherapies, today announces new positive
clinical data from the Company's ongoing Phase I/II BEXMAB study.

 

The BEXMAB study (ClinicalTrials.gov: NCT05428969) investigates bexmarilimab,
Faron's wholly owned immunotherapy asset, in combination with standard of care
(SoC) in the aggressive hematological malignancies of relapsed/refractory
(r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The
data reported here builds on earlier positive results presented on June 9,
2023 at the European Hematology Association (EHA) 2023 Hybrid Congress.

 

BEXMAB Phase I Study Update:

 

·    Three of five patients in 6 mg/kg bexmarilimab + azacitidine doublet
dosing cohort showed an objective response (OR) of complete remission of
blasts in the bone marrow (mCR).

·    In the three out of five patients in the 6 mg/kg + azacitidine
doublet cohort, one patient also achieved a complete recovery of blood counts
(CR).

·    Eight of 15 ORs were observed across all three doublet dosing
cohorts.

·    Four of the eight patients across the three doublet dosing cohorts
(1, 3 and 6 mg/kg) failed SoC hypomethylating agents (HMAs).

·    All three patients with MDS and prior HMA failure demonstrated ORs
(partial response (PR), mCR and CR) across dosing cohorts.

·    Four patients out of six in the triplet dosing cohort treated with
azacitidine, venetoclax and bexmarilimab have shown objective response.

 

"We are extremely encouraged by the continued efficacy signals of bexmarilimab
and the long duration of the responses seen so far," said Dr. Mika Kontro,
Associate Professor, Helsinki University Hospital Comprehensive Cancer Center
and Principal Investigator of the BEXMAB trial. "Our goal is to offer a unique
hope for patients with no other treatment options in this late stage of AML
and MDS."

 

Faron plans to seek FDA advice during the Q3 2023. It also expects to advance
to the Phase II part of BEXMAB in the H2 2023 in patients who are refractory
to SoC in AML and have failed HMAs in MDS.

 

"The data indicates bexmarilimab has the strong potential to tackle an unmet
medical need in relapsed/refractory AML and MDS," said Chief Medical Officer
Dr. Marie-Louise Fjällskog. "We're excited to advance bexmarilimab as a
leading agent in the fight against cancer and look forward to generating
further supporting data ahead of an anticipated BLA filing in H1 2025."

 

Conference Call and Webcast

The Company's management team will host a conference call and webcast with
investors and analysts to discuss the data later this morning on Wednesday,
July 19, 2023, at 8:30 am ET. The live call may be accessed by dialing (877)
407-3982 for callers in the US and (201) 493-6780 for international callers
and entering the conference ID: 13740209. The live webcast presentation with
accompanying slides will be accessible here
(https://viavid.webcasts.com/starthere.jsp?ei=1625480&tp_key=01bb7cc4d7)
and on the Investor Relations Calendar page of the Company's website at
www.faron.com/investors/calendar (http://www.faron.com/investors/calendar) .
Following the completion of the event, a replay will be available on the
Company's website.

 

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 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 (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
(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)
.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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