REG - Faron Pharma. Oy - Initial positive data from Phase 2 of BEXMAB

Faron Pharmaceuticals OyAnnouncement

20/05/2024 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:20240520:nRST0058Pa&default-theme=true

RNS Number : 0058P  Faron Pharmaceuticals Oy  20 May 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or the "Company")

 

 

Inside Information: Faron Reports Initial Positive Phase 2 Read-out in
HMA-resistant MDS

 

Company announcement, Inside Information, 20 May 2024 at 7:00 a.m. BST / 9:00
a.m. EEST

 

Key highlights

-      Initial preliminary phase 2 read-out from the BEXMAB Trial
confirms earlier positive Phase 1 findings in MDS patients with prior HMA
failure

-     In Phases 1 & 2, 14 MDS patients who are refractory or relapsed
on HMA (r/r MDS) and have no effective treatment options, show an objective
response rate (ORR) of 79%

-     The BEXMAB Phase 1 MDS patients with prior HMA failure are
experiencing an estimated median overall survival (mOS) of approximately 13
months currently, compared to the 5-6 months that would typically be expected
under standard of care historically

 

TURKU, Finland - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a
clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor
targeting approach to reprogramming myeloid cells to activate anti-tumor
immunity in hematological and solid tumor microenvironments, today provided
first data from patients treated during the Phase 2 part of the ongoing BEXMAB
trial in myelodysplastic syndrome (MDS) patients that have failed a
hypomethylating agent (HMA), also known as relapsed/refractory MDS (r/r MDS).
There are limited viable treatment options for r/r MDS and the mOS for these
patients is only 5.6 months historically (Prebet et al. 2011).

 

The BEXMAB Phase 1 results have already indicated a high overall response rate
(ORR) of 87.5% (7/8) amongst HMA-failed MDS patients treated with a
combination of bexmarilimab + azacitidine. There are now a total of 14
HMA-failed MDS patients treated in both Phase 1 & 2 with this novel
combination. The treatment has been well tolerated, without any dose-limiting
toxicity.  The ORR in this otherwise untreatable population is 79% (11/14).
The current true remission rate is 64% (9/14). Similar size patient cohorts
treated with existing alternatives have reported 0-20% ORR, without deep and
durable remissions.

 

The best responses for these 14 patients are as follows: 1 complete response
(CR), 7 marrow complete remissions (mCR), 1 partial response (PR), 2
hematological improvements, 2 stable diseases (SD) and 1 progressive disease
(PD). Two patients have moved on to receive bone marrow transplantation for a
possibility of curative treatment. This is seldom seen in this population
because patients usually cannot be brought to remission. For Phase 1 patients
with adequate follow-up available the estimated mOS is currently 13.4 months,
but still subject to change.

 

Dr. Amer Zeidan, Associate Professor of Medicine, Chief of Hematologic
Malignancies Division, Director of  Hematology Early Therapeutics Research,
and leader of the clinical program and the Clinical Research Team for Leukemia
and Myeloid Malignancies at Yale Cancer Center, who is also a leading
investigator on the trial, said: "Management of patients with higher risk MDS
after HMA failure is very challenging and with very limited options, and is
currently considered one of the most urgent unmet clinical needs in MDS.
Bexmarilimab is a promising agent that works by modulating the immune system
and in early data from the ongoing clinical trial in MDS appears to have a
very good safety profile and promising clinical activity, especially in median
survival after HMA failure. While these are early data and in a small number
of patients, if these findings continue to hold up, they would position
bexmarilimab to potentially fill a very important clinical gap in the
management of  MDS patients".

 

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: "This is a
significant milestone for Faron. Many of us have recognized the grave need for
new treatment options in r/r MDS. With these first results from the Phase 2
continuing the positive results already seen in Phase 1, we are committed to
rapidly advancing Bexmarilimab to market, because patients are waiting for
treatment options like this".

 

Faron will be hosting a virtual webinar to discuss these data the day after
tomorrow, Wednesday, May 22nd, at 17.00 EEST/15.00 BST

 

To register for the event visit:
https://faron.videosync.fi/bexmab-study-update-may2024
(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ffaron.videosync.fi%2Fbexmab-study-update-may2024&data=05%7C02%7C%7C8a35a0457bf04406c9d808dc7588b822%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638514477288892334%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=YYYf0KRIoKTlVaATfijY4KyCbZ8gNPFW%2BMcoQVdoYls%3D&reserved=0)
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.

 

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  MSCUKORRSKUVAUR