What it does
Faron Pharmaceuticals Oy (LON:FARN)(NASDAQFIRSTNORTH:FARON) is a Finnish drug discovery firm focusing on two programmes: Clevengen and Traumakine.
Immunotherapy treatment Clevegen is in a phase I/II trial (MATINS) for metastatic cutaneous melanoma as well as hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancers.
Tumour cells are adept at creating a shield around themselves to evade detection by the immune system, therefore staving off destruction.
Clevegen has been designed to recognise cancer and break the tumour's protective shell.
The treatment is an anti-Clever-1 antibody which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages.
Ultimately, if it is successful, this new breed of treatment will be used in combination with PD-1 inhibitors to tackle the killer disease.
Faron was also given the green light to broaden the scope of its phase I/II cancer trial after a review of the interim data.
The MATINS study of the immunotherapy Clevegen will now take in seven further strains of the disease besides the two already assessed - colorectal and ovarian.
In June it confirmed the generic name, bexmarilimab.
Traumakine has been rejuvenated following the disappointment over its phase III trial result.
As a treatment for lung inflammation condition ARDS its missed its target with no benefit against the placebo.
However, since then Faron has identified that it was steroids used alongside the drug that led to the unexpected result.
Traumakine is an interferon-beta that helps to stop lung inflammation and has come to the fore as a way potentially to help severe coronavirus sufferers.
The latest development has seen Traumakine admitted to a large-scale global programme (REMAP-CAP) that will assess its potential in treating severe pneumonia, including patients with coronavirus (COVID-19).
Faron said its interferon beta-1 formulation will be delivered intravenously, which the company reckons offers the best “delivery route” for critically ill patients.
It will also be compared in the study with other treatments, including hydrocortisone medications. These steroid-based interventions, used in patients in respiratory distress, were seen as the potential root cause of a failed Faron phase III study of Traumakine.
It was also added to the HIBISCUS ( Human Interferon Beta In Severe CoronavirUS) trial will focus on intensive care patients with ARDS caused by viral infection such as coronavirus and influenza.
The phase II/III pivotal, randomised, placebo controlled study aims to recruit 350 patients over six to eight months throughout the US with “many significant hospitals participating”.
How it is doing
In October, Faron said it was disappointed by results from a study that showed little impact from interferon Beta-1a injected under the skin in halting coronavirus-related deaths.
The World Health Organisation's (WHO) Solidarity trial compared 1412 patients who received IFN beta-1a and 2050 control subjects not receiving IFN beta-1a.
The results show that subcutaneous interferon (IFN) beta-1a was found to be safe, but ineffective to reduce overall mortality in hospitalised patients with COVID-19.
Faron’s IFN Beta-1a candidate Traumakine was part of the Solidarity trial, but the company said it only became available very late in the observation period and its understanding was that it had seldom been used.
Meanwhile, cancer drug development Clevegen is also making good progress through phase I/II of the ongoing MATINS trial.
This trial was recently expanded to ten types of the disease, though the next part will focus on four types - colorectal, ovarian, cutaneous melanoma and uveal melanoma.
What the boss says: Markku Jalkanen, chief executive
"These first results from the Solidarity Trial are disappointing, given the need for new therapeutics to support the global response to COVID-19."
“They do support our long-held view that IFN beta-1a is likely to be ineffective when given subcutaneously."
“The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling."
"We continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body's own IFN beta signalling - the first line of defence against viral infection - and provide optimal exposure to the lung vasculature."
"Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150x higher peak concentration in the lung vasculature without higher systemic exposure, which we believe makes this method of administration highly effective and safe... We will continue to pursue the science behind this."