REG - Faron Pharma. Oy - FDA Orphan Drug Designation for Bexmarilimab

Faron Pharmaceuticals OyAnnouncement

29/08/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230829:nRSc5473Ka&default-theme=true

RNS Number : 5473K  Faron Pharmaceuticals Oy  29 August 2023

 

Faron Pharmaceuticals Ltd.

("Faron" or "the Company")

 

 Inside Information:  Faron Receives FDA Orphan Drug Designation for
Bexmarilimab in Acute Myeloid Leukemia

 

·    ODD further strengthens bexmarilimab program by offering clinical
development and commercialization benefits

·    Expected completion of dose escalation, readout of enrichment
cohorts, and Phase II initiation in Q4 2023

 

Company Announcement, August 29, 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 the U.S. Food
and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its
wholly owned asset bexmarilimab, for the treatment of acute myeloid leukemia
(AML).

 

FDA's Office of Orphan Drug Products grants orphan status to support the
development of medicines for rare disorders that affect fewer than 200,000
people in the U.S. ODD provides Faron with certain benefits, such as market
exclusivity upon regulatory approval if received, exemption of FDA application
fees, and tax credits for qualified clinical trials.

 

"Receiving Orphan Drug Designation from the FDA signifies our continued
progress and commitment to develop bexmarilimab as a potential treatment for
AML," said Chief Medical Officer Dr. Marie-Louise Fjällskog. "The designation
represents a milestone in our development journey, one that we believe when
combined with standard of care, will lead to better patient outcomes and
improved quality of life."

 

Bexmarilimab is currently in Phase I/II BEXMAB study (ClinicalTrials.gov:
NCT05428969) in combination with standard of care (SoC) for the treatment of
aggressive hematological malignancies of relapsed/refractory AML and
myelodysplastic syndromes (MDS). Last month, Faron reported
(https://otp.tools.investis.com/clients/uk/faron2/rns/regulatory-story.aspx?cid=2223&newsid=1703177)
updated, positive data from the Phase I portion of the trial. Three of five
patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved
objective responses and eight (out of 15 patients) objective responses were
observed in all three doublet dosing cohorts, with one patient remaining on
treatment for 13 months.

 

The completion of dose escalation, readout of enrichment cohorts and
initiation of the Phase II portion of the BEXMAB trial are expected in Q4
2023.

 

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.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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCPPMPTMTITBAJ