Faron Pharmaceuticals said Thursday in a press release that it is currently opening two UK sites (London, Birmingham) to expand the Matins trial, testing Clevegen, following recent CTA approval by the UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA). The company also said it will seek pre-IND advice from the US Food and Drug Administration (FDA) to open sites in USA prior to entering the cohort expansion part of the trial.
The phase I/II Matins clinical trial is testing Clevegen, Faron’s novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours. The company noted in the press release it is advancing as expected at trial sites in Finland, and that dosing has moved to the second level (1mg/kg) with no signs of toxicity.
Due to high interest in potential new therapies in the immuno-oncology field, either as monotherapy or in combination, the Company is currently engaged in partnering discussions with several parties and hopes for a positive outcome from these negotiations during 2019.
Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We have previously shown that Clevegen has the ability in experimental settings to convert the macrophage population from immune suppressive macrophages to immune active myeloid cells, which are believed to initiate the tumour fight by host immune cells.
Jalkanen said that the initial data from the Matins trial appear to confirm that this immune switch can also take place in cancer patients. He said that these biomarker data will prove valuable to help determine the optimal dose as the trial continues.