Faron Pharmaceuticals Oy (LON:FARN) shares shot higher on Friday as its chief executive Dr Markku Jalkanen said he is “thrilled” with the progress of the firm’s early-stage cancer clinical trial.
Faron has outlined plans to expand the phase I/II MATINS study of its Clevegen treatment in patients with CLEVER-1 positive cancer types.
It said it intends to keep the colorectal cancer expansion group open, enrolling patients while more data is generated.
And the company said it will approach the authorities to see if it can garner fast-track approval for the drug as a last-line treatment for those people who have exhausted all other options.
“On the basis of Clevegen's current safety profile and potential in patients who have exhausted by all other treatment options, the company believes it may seek initial regulatory approval supported by data from the expanding MATINS trial by 2022,” Faron told investors.
Nine patients have been dosed so far with Clevegen, a new type of immune-oncology drug.
The trial thus far has shown:
- Clevegen well tolerated also at high doses
- A consitent shift in immune cell profiles
- Anti-cancer responses continue
On the latter, two patients have benefited from receiving Clevegen.
A so-called partial responder with colorectal cancer has continued to see lung metastasis shrink. The person’s tumour load marker, which measures tumour mass, has also “normalised”.
A second person with colorectal cancer has seen a 40% decrease carcinogenic embryonal antigens, while the tumour has stabilised.
Partnering discussions for Clevegen are expected to be concluded sometime in the second half, Faron said.
Once it has tied up a deal, the company hopes to expand the clinical development of the promising drug to include the use of Clevegen in combination with other immunotherapies.
CEO Jalkanen told investors: “We are thrilled with the progress the MATINS study has made during the last few months.
“We believe we have the first macrophage immune checkpoint drug in clinical development promoting immune activation and are encouraged by the latest data indicating potential early efficacy and good tolerability.”
In morning trading, Faron shares topped the London market's gainers board, up 24% to 193p.
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