REG - Faron Pharma. Oy - Faron Announces Positive FDA Feedback

Faron Pharmaceuticals OyAnnouncement

11/07/2024 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:20240711:nRSK9473Va&default-theme=true

RNS Number : 9473V  Faron Pharmaceuticals Oy  11 July 2024

Faron Pharmaceuticals Ltd.

 

("Faron" or the "Company")

 

 

Inside Information: Faron Announces Positive FDA Feedback

 

Company announcement, Inside Information, 11 July 2024 at 7:00 a.m. BST / 9:00
a.m. EEST

 

Key highlights

-       Faron had a formal meeting with the FDA to discuss the
registrational clinical development plan for bexmarilimab in the treatment
myelodysplastic syndrome (MDS).

-       The FDA acknowledged the difficulties of running a randomized
study with a comparator in the relapsed / refractory setting (r/r) and instead
proposed that Faron conduct a confirmatory Phase III study in frontline
high-risk MDS (HR MDS), that would not require a separate Phase III in r/r
MDS.

-      This FDA guidance is part of Project Frontrunner, an initiative
intended to bring promising new cancer treatments as early as possible to a
broader patient population.

-       The Phase III suggested by the FDA targets a significantly
larger patient population with potential for faster approval earlier than
anticipated, speeding up and increasing our sales forecast for bexmarilimab.

 

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 provides
information on the result of its formal Type D Scientific Advice Meeting with
the USA Food and Drug Administration (the FDA) regarding the registrational
study plan for its drug candidate bexmarilimab in relapsed and refractory high
risk MDS (r/r MDS).

 

Given the previously reported promising results of treating r/r MDS using a
combination of bexmarilimab + azacitidine to overcome primary or developed
resistance to azacitidine, Faron had proposed to move into a randomized
registrational Phase III study for the treatment of r/r MDS using bexmarilimab
+ azacitidine against the investigator's choice of a hypomethylating agent
(HMA). Instead, given the encouraging efficacy already seen in both frontline
and r/r HR MDS and the well-established safety profile of bexmarilimab, the
FDA proposed that after the ongoing Phase II BEXMAB study in r/r MDS, Faron
should move directly into a registrational blinded randomized frontline HR MDS
study investigating bexmarilimab + azacitidine against placebo + azacitidine.
The FDA noted that given the relatively modest efficacy of single agent
azacitidine and the current response rates with bexmarilimab that the size of
such a frontline study may not have to be substantially larger than the
proposed study in the r/r setting.

Further, the FDA suggested such a frontline study could be seen in the context
of FDA's Project Frontrunner. Project FrontRunner is an FDA Oncology Center of
Excellence (OCE) initiative to encourage drug sponsors to develop and seek
approval of promising new cancer drugs for advanced diseases in an earlier
clinical setting, rather than the usual approach to develop and seek approval
of a new drug for treatment of patients who have received numerous prior lines
of therapies or have exhausted available treatment options. The FDA
guidelines give different possible approval strategies to sponsors, including
the conduct of a frontline trial supporting an accelerated approval in the r/r
settings. Project FrontRunner | FDA
(https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner)

Subject to continued positive results, the FDA's feedback means that a
separate Phase III in r/r MDS would not be required and Faron's ongoing BEXMAB
Phase II study could be the registrational trial for patients with r/r MDS,
given that the benefit of bexmarilimab + azacitidine against azacitidine alone
will be confirmed in an interim read-out of the response rate from a Phase III
in frontline HR MDS study. Accelerated approval for frontline HR MDS would
come from the response rate of this single Phase III study and the full
approval from the survival read-out of the same study.

 

"Faron is now adjusting its development plan accordingly", says Dr. Juho
Jalkanen, Chief Executive Officer of Faron. "This is very positive feedback
and exceeds our expectations. The FDA's proposal significantly reduces
development costs and timelines to bring bexmarilimab therapy to all HR MDS
patients. This feedback underlines that the FDA sees the high unmet need in HR
MDS, a condition for which new treatment options are urgently needed. The
FDA's proposal has provided Faron with clear guidance on the path to approval
that will confirm the highly encouraging results bexmarilimab has already
obtained in overcoming resistance to azacitidine. We are extremely grateful
for this feedback and will work hard to deliver on this recommendation."

 

"The suggested Phase III targets a significantly bigger patient population
sooner than anticipated, speeding up and increasing our sales forecast for
bexmarilimab. This does not significantly impact our ongoing activities and
cash runway, as the Phase II in r/r MDS continues as planned. In addition, we
will enroll more frontline HR MDS patients into the Phase I part of BEXMAB to
better understand the effect size, which will enable us to successfully power
and design the proposed frontline Phase III study. We believe we can offset
this additional clinical investment through other savings, so that it will not
have a significant impact on our cash runway. The only deviation from the
original plan is that instead of a Phase III in r/r MDS, we will start
preparations for a Phase III in frontline HR MDS, which is a remarkable
achievement.", continues Dr. Jalkanen.

 

Faron will be hosting a virtual webinar to discuss the FDA feedback and
updated clinical development plans July 15(th), at 15.00 EEST / 13.00 BST.

 

To register for the event visit:
https://faron.videosync.fi/fda-feedback-update
(https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ffaron.videosync.fi%2Ffda-feedback-update&data=05%7C02%7C%7C4d2acd2cdc9449b061da08dca004ea23%7Ca2d9b7a432f64a96b03727499230d5fd%7C1%7C0%7C638561190176799871%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=gYnbRC0oCtlL5etTioUHtru5y%2F9XusszCF8u223cC3Q%3D&reserved=0)
or contact the IR team for more information at investor.relations@faron.com
(mailto:investor.relations@faron.com) .

 

For the purposes of MAR and UK MAR, the person responsible for arranging for
the release of this announcement on behalf of Faron is Juho Jalkanen, Chief
Executive Officer.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals
E-mail: investor.relations@faron.com

 

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  MSCSFEFASELSEEW