Faron
Pharmaceuticals Oy
("Faron"
or the "Company")
Faron
confirms plans for the coming months under new
leadership
- Initial data
from ongoing Phase 2 part
of
BEXMAB trial anticipated next month
- Incoming CEO, Juho Jalkanen, to accelerate discussions with US
regulator to coordinate plans for obtaining marketing approval for
MDS patients that have failed HMA
Press Release, April 16, 2024 at
9:00 (EEST) / 7:00 AM (BST) / 2:00 AM (EDT)
TURKU, FINLAND / BOSTON,
MA - Faron Pharmaceuticals Ltd. (AIM: FARN,
First North: FARON), a clinical-stage biopharmaceutical company
pursuing a CLEVER approach to reprogramming myeloid cells to
activate anti-tumor immunity in hematological and solid tumor
microenvironments, today announces ongoing plans and activities for
the coming months following the recent announcement of the proposed
appointment of Dr. Juho Jalkanen as Chief Executive Officer,
effective 1 May 2024.
Initial data from the ongoing Phase
2 part of the BEXMAB trial, evaluating the safety and efficacy
of bexmarilimab in combination with
standard of care (SoC) in patients with hypomethylating agents
(HMAs)-refractory or relapsed myelodysplastic syndrome
(MDS), is expected to be announced during the week commencing
20 May 2024. This data read out will be important for ongoing
partnering discussions and the major upcoming industry events that
Faron will be attending, including the American Society for
Clinical Oncology (ASCO) annual meeting and the Bio International
Convention, taking place in June 2024.
Given the promising data already
seen in the Phase 1 part of the trial, among HMA-failed MDS
patients who have no approved treatment options, the Company plans
to approach the US Food and Drug Administration (FDA) earlier than
planned this year, seeking a Scientific Advice meeting regarding
its registrational study plan, in order to coordinate and finalize
plans that may lead to marketing approval.
"2024 is set to be a pivotal year
for Faron in the delivery of key milestones that will be critical
to the further development of bexmarilimab," said Dr. Juho Jalkanen,
Faron's incoming Chief Executive Officer. "In my new role as CEO I
am excited to start executing on some of these key activities and
to accelerating important discussions with the FDA as we map our
future plans for bexmarilimab together. There is a
tremendous need for an effective treatment in HMA-failed MDS
patients and so we are very keen to ensure we get this treatment
option to patients as soon as we can."
For
more information please contact:
Faron Pharmaceuticals
Investor Contact
LifeSci Advisors
Daniel Ferry
Managing Director
daniel@lifesciadvisors.com
+1 (617) 430-7576
ICR Consilium
Mary-Jane Elliott, David Daley,
Lindsey Neville
Phone: +44 (0)20 3709
5700
E-mail: 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 Faron Pharmaceuticals
Oy
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
and as a monotherapy in last line solid cancers. Further
information is available at www.faron.com.