Faron Pharmaceuticals Oy (LON:FARN) is putting the building blocks in place for commercial production of Traumakine, its investigational intravenous (IV) interferon (IFN) beta-1a prospect for the treatment of acute respiratory distress syndrome (ARDS).
The Finnish clinical-stage biopharmaceutical company has received a guarantee from Finnvera Oyj, the state-owned financing company, for a €2.5mln loan that will be provided by Danske Bank.
The loan is for seven years, with repayments commencing after two years. Interest costs equate to roughly 4.1% above the EURIBOR rate.
Proceeds from the loan will be used to further expand the use of a new cell line that Faron plans to establish using the previously received Business Finland loan of €2.1mln announced in mid-June, which will be used in the future commercial-scale production of Traumakine.
Faron has also selected AGC Biologics as the new manufacturing partner for commercial-scale production of Traumakine.
AGC, a leading global biopharmaceutical contract development and manufacturing organisation, is already the commercial-scale manufacturer of bexmarilimab, Faron's wholly-owned novel precision cancer immunotherapy (Clevegen). Faron said it has been very satisfied with AGC Biologics' work.
Traumakine (IFN beta-1a ) continues to be investigated as a potential coronavirus (COVID-19) treatment in global trials, including the World Health Organization's (WHO) Solidarity trial. In July, WHO took the decision to remove the hydroxychloroquine and lopinavir/ritonavir treatment arms from the trial due to insufficient evidence of benefit, which leaves IFN beta-1a and remdesivir as the only two drugs remaining in the trial, subject to WHO announcing further new compounds for inclusion.
IFN beta-1a had previously been included in a treatment arm testing it in combination with lopinavir/ritonavir. IFN beta-1a now remains as a monotherapy.
In addition to the Solidarity trial, Faron continues to investigate Traumakine in two other clinical trials, the ongoing global REMAP-CAP (Randomised, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, and the US HIBISCUS (Human Interferon Beta In Severe CoronavirUS) trial.
"We are very pleased to have secured additional resources that will enable us to progress Traumakine manufacturing to support its potential future commercial use,” said Markku Jalkanen, Faron’s chief executive officer in a statement.
“The science behind interferon (IFN) beta and its potential to prevent multi-organ failure in severe COVID-19 patients is compelling. Administering an IV formulation to strengthen the body's own IFN beta production – its first line of defence against viral infection - provides optimal exposure to the lung vasculature, which is what we believe critically ill patients need,” Jalkanen added.
Shares in Faron were up 2.8% at 467.5p in early deals.