Last checked at (Sharecast News) - Clinical-stage biopharmaceuticals company Faron Pharmaceuticals has selected contract development and manufacturing organisation AGC Biologics as the commercial-scale manufacturer of 'Clevegen', it announced on Tuesday.
The AIM-traded firm described Clevegen as its wholly-owned novel precision cancer immunotherapy, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours.
It said the recent clinical progress with Clevegen, and recommendations from the data monitoring committee of the ongoing phase 1 and 2 'MATINS' study to expand Clevegen's development across nine different cancer types, indicated a requirement for increased Clevegen drug substance.
The commercial scale manufacturing process established by AGC Biologics would also provide a dossier to support future regulatory filings in Europe and the United States.
Faron said it believed that AGC Biologics, with its regulatory knowledge on commercial-scale production, state-of-the art facilities in three continents, and multiple 'current good manufacturing practices' (cGMP) manufacturing lines at a variety of scales for mammalian cell culture, would allow the capacity and technological flexibility to meet its needs.
AGC Biologics had "decades of experience" in the manufacture of biotechnological products, including commercial market supplies of FDA, PDMA and EMA approved products, the board said.
"We are pleased to initiate this agreement with AGC Biologics preparing for commercial scale manufacturing of Clevegen," said chief executive officer Dr Markku Jalkanen.
"This will allow flexible and cost-efficient manufacturing to fulfil the growing need in our clinical development programme while ensuring rapid and regulatory ready scale-up of the production for future potential commercial needs.
"This will be important to progress, alongside the clinical development of Clevegen, and will support our discussions with global regulators as part of the end of phase II meetings for Clevegen."
At 0900 BST, shares in Faron Pharmaceuticals were up 5.56% at 380p.
20 May 2020 10:37
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