SEATTLE, May 5, 2020 /PRNewswire/ -- AGC Biologics, a
global Biopharmaceutical Contract Development and Manufacturing
Organization (CDMO), has been selected to commercially manufacture
the treatment Clevegen for partner Faron Pharmaceuticals Oy (AIM:
FARN, First North: FARON), a clinical stage biopharmaceutical
company. Clevegen is a humanized anti-Clever-1 antibody which
targets CLEVER-1 positive tumour associated macrophages (TAMs) and
converts these highly immunosuppressive M2 macrophages to immune
stimulating M1 macrophages. This unique macrophage-directed
immuno-oncology switch may be used alone or in combination with
other cancer treatments.
Data from Faron's ongoing MATINS trial has shown that Clevegen
is safe and well-tolerated, making it a low-risk candidate for
combination with existing cancer therapies. Clevegen has also shown
early clinical benefits in patients who have exhausted all other
treatment options.
"We are pleased to initiate this collaboration with AGC
Biologics aiming at industrial scale manufacturing of Clevegen,"
says Dr. Markku Jalkanen, Faron's
CEO. "This allows flexible and cost-efficient manufacturing to
fulfil the growing need in clinical development while ensuring
rapid and regulatory-ready scale up of the production for
commercial needs. At Faron, we feel it's important to progress
along the clinical development and report to the regulators (FDA,
EMA) at the end of the phase II meeting for Clevegen. This could
take place, depending on the MATINS study Part II results, as soon
as H2-2020."
"Our priority has always been to serve our customers with a
strong commitment to continued innovation," said Patricio Massera, CEO of AGC Biologics. "We're
proud to be partnering with Faron on such an important treatment
and sharing our decades of experience in commercial scale
production of biotechnological products."
About Faron Pharmaceuticals Oy:
Faron (AIM: FARN,
First North: FARON) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline based on the
receptors involved in regulation of immune response in oncology and
organ damage. Clevegen, its precision immunotherapy, is a novel
anti-Clever-1 antibody with the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. Currently in phase I/II clinical development as a
novel macrophage checkpoint immunotherapy for patients with
untreatable solid tumours, Clevegen has potential as a single-agent
therapy or in combination with other standard treatments including
immune checkpoint molecules. Traumakine, the Company's pipeline
candidate to prevent vascular leakage and organ failures, has
completed a phase III clinical trial in Acute Respiratory Distress
Syndrome (ARDS). Plans for its future development are being
finalised to avoid interfering steroid use together with
Traumakine. Faron is based in Turku,
Finland. Further information is available at
www.faron.com.
About AGC Biologics:
AGC Biologics is a leading
global Contract Development and Manufacturing Organization (CDMO)
with a strong commitment to deliver the highest standard of service
to clients and partners. The company currently employs more than
900 employees worldwide. AGC Biologics' global network spans three
continents, with cGMP-compliant facilities in Seattle, Washington; Copenhagen, Denmark; Heidelberg, Germany; and Chiba,
Japan.
AGC Biologics offers deep industry expertise and unique
customized services for the scale-up and cGMP manufacture of
protein-based therapeutics, from pre-clinical to commercial
mammalian and microbial production. Integrated service offerings
include plasmid (GMP pDNA) manufacturing, cell line development,
bioprocess development, formulation, analytical testing, antibody
treatment development and conjugation, cell banking and storage and
protein expression, including the proprietary CHEF1®
Expression System for mammalian production.
Learn more at www.agcbio.com.
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SOURCE AGC Biologics