REG - Faron Pharma. Oy - Positive FDA Feedback to Progress Bexmarilimab

Faron Pharmaceuticals OyAnnouncement

22/03/2023 07:15

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RNS Number : 7719T  Faron Pharmaceuticals Oy  22 March 2023

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Inside Information: Faron Announces Positive US Food and Drug Administration
(FDA) Feedback to Progress Bexmarilimab as a Monotherapy in Solid Tumors

·    Green light for continued clinical development after data package
review

·    Alignment with company's selection of 1 mg/kg IV once-every-3-weeks
(Q3W) as dose for further evaluation

·    Supportive of biomarker-driven approach with CLEVER-1 staining of
tumor biopsy

Company announcement, March 22, 2023 at 03:00 AM (EDT) / 07:00 AM (GMT) /
09:00 AM (EET)

Inside information

TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Oy (AIM: FARN, First
North: FARON), a clinical stage biopharmaceutical company focused on tackling
difficult-to-treat cancers, announces positive FDA feedback and
recommendations for the future development of bexmarilimab as a monotherapy in
multiple solid tumors. The agency's advice follows an end-of-Phase I/II
meeting this month. The Phase I/II MATINS trial is investigating bexmarilimab,
Faron's wholly owned precision immunotherapy asset, in multiple cancer
indications.

The official meeting minutes are consistent with the FDA's Project Optimus
initiative to reform dose optimization and the selection paradigm in oncology
drug development, which MATINS sought to comply with through multiple dose and
indication arms of the study.  FDA provided the following positive meeting
feedback which further aligns the agency's views on bexmarilimab with the
Company's, including:

·    Completed toxicology studies are adequate to support further clinical
development of single-agent (monotherapy) bexmarilimab into a registration
trial

·    Selection of 1 mg/kg IV Q3W as dose for further evaluation appears
reasonable, although additional data are required to establish the recommended
Phase II/III dose for specific cancer(s)

·    Valuable feedback and guidance on further development of a simple,
validated staining assay to identify patients with CLEVER-1 positive tumors
for clinical trial inclusion

"We are pleased to have received these positive and supportive FDA
recommendations for the continued clinical development of bexmarilimab as a
monotherapy in solid tumors," said CEO Markku Jalkanen. "As a first-in-human
study for bexmarilimab, MATINS has laid the groundwork for multiple routes to
market."

Faron had previously announced a meeting with the agency would occur this
quarter.

"FDA's feedback on the MATINS study gives Faron an excellent roadmap to plot
out bexmarilimab's future strategy," said Chief Medical Officer Marie-Louise
Fjällskog. "We thank the FDA for its time and consideration of our briefing
package and anticipate additional fruitful interactions."

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

 

For more information please contact:
 
Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com (mailto:Jennifer.Smith-Parker@faron.com)

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com (mailto:julia.balanova@faron.com)

investor.relations@faron.com (mailto:investor.relations@faron.com)

Phone: +1 (917) 306-6096

 

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

 

Consilium Strategic Communications

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com (mailto:faron@consilium-comms.com)

Phone: +44 (0)20 3709 5700

About MATINS

MATINS has demonstrated a positive safety profile in more than 200 patients
treated with bexmarilimab. The study has observed an approximate 30% clinical
benefit rate in several tumor types, which is associated with an interferon
gamma (IFN-y) increase and leads to a significant survival benefit. Moreover,
responding patients can be potentially identified using baseline IFN-y or
CLEVER-1 expression. CLEVER-1 is a novel immune checkpoint, a receptor shown
to promote an immunosuppressive environment.

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its
subsidiaries, is a clinical stage biopharmaceutical group focused on building
the future of immunotherapy by harnessing the power of the immune system to
tackle cancer and inflammation. Bexmarilimab, a novel anti-CLEVER-1 humanized
antibody, is its investigative precision immunotherapy with the potential to
provide permanent immune stimulation for difficult-to-treat cancers through
targeting myeloid function. Currently in Phase I/II clinical development as a
potential therapy for patients with hematological cancers and untreatable
solid tumors, bexmarilimab has potential as a single-agent therapy or in
combination with other standard treatments including immune checkpoint
molecules. In terms of other pipeline assets, Traumakine® is an
investigational intravenous (IV) interferon beta-1a therapy for the treatment
of hyperinflammatory conditions. Faron is headquartered in Turku, Finland.
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 particular, the early data
from initial patients in the MATINS trial may not be replicated in larger
patient numbers and the outcome of clinical trials may not be favorable or
clinical trials over and above those currently planned may be required before
the Company is able to apply for marketing approval for a product. 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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