AGC Biologics will manufacture novel precision cancer immunotherapy treatment Clevegen
(SEATTLE), May 5, 2020 -- 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.