Faron Pharmaceuticals Ltd (LON:FARN) shares surged 45% after it said regulators have given the company the green light to expand a phase I/II clinical trial of its cancer immunotherapy to the US.
It follows the Food & Drug Administration’s approval of Clevegen as an investigational new drug.
American patients will now be recruited to Faron’s MATINS study, which will assess the tolerability, safety and potential efficacy of the new treatment in people with certain types of solid tumour.
The precision cancer immunotherapy targets Clever-1 positive tumour associated macrophages, which are thought to be associated with cancer growth and spread.
MATINS already underway
The MATINS trial is already underway at oncology centres across Europe.
Of the FDA sign-off, Faron chief executive, Dr Markku Jalkanen, said: “This approval will allow us to expand MATINS into the US using the same protocol both in Europe and in the US, accelerating our understanding of this novel precision medicine in cancer patients who are refractory to all other treatment options and streamlining the regulatory processes.
“With the US IND now approved, in due course, we plan to file applications for Breakthrough status in the US and Prime status in Europe, further facilitating regulatory interactions during the development of Clevegen."
Clevegen trialled for solid tumours
Immunotherapy treatment Clevegen is on 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 cell’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.
The shares rose 74p to 239p.