Faron Pharmaceuticals shares surge on latest Clevegen data
By Josh White
Date: Thursday 21 Feb 2019
(Sharecast News) - Shares in Faron Pharmaceuticals were surging on Thursday morning, after it announced an update on early observations on immunity and clinical response of MATINS patients after administration of its 'Clevegen' product.
The AIM-traded clinical stage biopharmaceutical for said the phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen - its wholly-owned novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours - was advancing as expected at trial sites in Finland.
Dosing had moved to the second level - 1mg per kilogram - with no signs of toxicity.
Faron described Clevegen as a novel 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.
In pre-clinical models, inhibition of Clever-1 decreased tumour-associated macrophages and myeloid derived suppressor cells within the tumour, and activated tumour-killing CD8+ cells, leading to robust anti-tumour activity.
It said early immune biomarker data from the first two patients dosed in the MATINS trial at 0.3mg per kilogram indicated an increase in CD8+ and CD4+ T cells, which reportedly played a central role in cell-mediated immunity.
A single dose of Clevegen increased blood CD8+ cells and the CD8+/CD4+ ratio in patients by 24% and 15%, respectively.
Those patients also experienced a 22% decrease in their blood regulatory T-cell content (T-reg) on day two, which Faron said was linked to immune suppression in cancer patients.
That change in immune activation resulted in a material increase in natural killer (NK) cells on day 15, by 16% in the first patient and 148% in the second patient from the pre-dose level.
Faron said those alterations returned to near pre-dose levels ahead of the second dose.
During the second dosing level of the third MATINS patient, of 1mg per kilogram, similar responses were observed but at "significantly faster and higher" rates.
On day two, CD8+ cells had increased 100%, the CD8+/CD4+ ratio by 26% and NK cells by 191%, while T-regs had declined 10% from the pre-dose value.
The company said it believed the findings, while limited to the trial's first three patients - one case of melanoma and two colorectal cancers - were "encouraging", alongside biochemical tumour and tumour load markers showing a decrease in carcinoembryonic antigen (CEA) and lactate dehydrogenase (LDH) serum levels.
Both indicated the potential early clinical benefit provided by Clevegen for late state cancer patients, Faron added.
It said it was currently opening two UK sites in London and Birmingham to expand the trial, following recent CTA approval by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The company also intended to seek pre-IND advice from the US Food and Drug Administration (FDA) to open sites in the United States prior to entering the cohort expansion part of the trial.
Due to high interest in potential new therapies in the immuno-oncology field, either as monotherapy or in combination, the company said it was currently engaged in partnering discussions with several parties and hopes for a positive outcome from those negotiations during 2019.
"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," said Faron chief executive officer Dr Markku Jalkanen.
"These initial data from the MATINS trial appear to confirm that this immune switch can also take place in cancer patients."
Jalkanen said the board was "very encouraged" by the findings, and by the potential early clinical benefits indicated through the biochemical and tumour load indicators, following several lines of previous ineffective treatments.
"These biomarker data will prove valuable to help determine the optimal dose as the trial continues and we look forward to generating further data to assess durability of effect and efficacy in a larger number of patients."
As at 1012 GMT, shares in Faron Pharmaceuticals were up 9.48% at 63.5p.
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