GCIFaron Pharma shares jump on Clevegen FDA approval
on Thursday received regulatory approval from the US FDA for its Investigational New Drug application to expand the MATINS trial for Clevegen into the United States.
The phase I/II MATINS clinical trial, already underway in Europe, is investigating the tolerability, safety and efficacy of Clevegen, Faron's wholly-owned precision cancer immunotherapy.
Faron’s MATINS trial previously found that Clevegen promoted immune activation in patients, potentially making it a new and effective macrophage immune checkpoint drug for cancer patients.
After this approval, Faron plans to open new study sites in the US to rapidly expand part II of the study, investigating Clevegen in various cancer cohorts.
Shares in Faron Pharmaceuticals were trading 40.91% higher at 232.5p on Thursday
Dr Markku Jalkanen, CEO of Faron, 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.”
He added: “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 targets Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours.
Cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, are all known to host a significant number of Clever-1 positive tumour associated macrophages (TAMs) and have approximately 2 million annual cases worldwide.
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