Faron Pharmaceuticals Oy (LON:FARN) (First North:FARON) has shared observations of its precision cancer drug, bexmarilimab, that suggest its immune-stimulating effects may be broader than first thought.
Researchers assessed data from the phase I/II MATINS clinical trial of the treatment, which targets Clever-1, a receptor known to be expressed on immunosuppressive macrophages (cells that engulf and destroy other cells).
They did so working with Kaiku Health, a data science company that uses an artificial intelligence platform to analyse patient results following treatment with cancer immunotherapies.
Firstly, it was found that the candidate showed early efficacy signs on cholangiocarcinoma, also known as bile duct cancer, alongside other four cohorts previously announced – cutaneous melanoma, colorectal cancer, hepatocellular cancer and ovarian cancer.
Secondly, it was found that a higher dosage of bexmarilimab could potentially work better on patients, so Faron may increase it from every three weeks to every fortnight or week and a half.
Faron said the latest scientific observations from the trial identified a new role for soluble Clever-1 related to its capacity to control T-cell activation. T cells are naturally part of our immune system and focus on specific foreign particles.
This suggests that the inactivation of Clever-1 as an immune suppressive molecule could be even broader and more important than previously thought.
Patients of the study were found to contain up to ten times the quantity of Clever-1 in liquid form compared to healthy subjects, which could explain the rapid effect of bexmarilimab in cancer patients.
Researchers tested the role of these higher levels of liquid Clever-1 in experimental settings, and found that it can control T cell activation directly.
Faron said it is a significant finding because Clever-1 could be a substantial inhibitor of T cell activating therapies.
Because Clever-1 is present in soluble form in our bodies, it can potentially suppress a patient’s whole immune system rather than just in some areas.
In a statement, Faron chief executive, Dr Markku Jalkanen, said: “Never during my career have I seen that a high baseline count of regulatory T cells (Tregs) predicts a good response to a therapy.
“Until now, it has always been the opposite. This is remarkable. Such observations now provide us with a much better understanding of the next steps required for bexmarilimab’s clinical development in pivotal studies and support its potential as a breakthrough therapy to deliver optimal clinical results in patients with hard to treat cancers.”
He added: “The new discovery of the role of soluble Clever-1 as an immune suppressive molecule is striking, indicating the soluble part of this receptor could cause systemic inhibition of T-cells in all locations of body, therefore controlling the general immune capacity in cancer patients.
“We hope to be able to overcome this inhibition just by increasing the dosing frequency of bexmarilimab to provide maximal binding and the removal of Clever-1 from body fluids and tissues, including tumours.”