LONDON (ShareCast) - (Sharecast News) - Clinical stage biopharmaceutical company Faron Pharmaceuticals announced on Thursday that the cohort expansion part of its phase 1 and 2 'MATINS' clinical trial, investigating the safety and efficacy of its wholly-owned novel precision cancer immunotherapy 'Clevegen', would begin with patients suffering from late-stage colorectal cancer as soon as the optimal dosing was determined.
The AIM-traded firm described Clevegen as a novel anti-Clever-1 antibody, which caused changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive myeloid cells to immune active macrophages.

That immune switch resulted in increased number of active tumour-killing CD8+ cells, it explained, leading to "robust" anti-tumour activity in pre-clinical models.

The decision to target colorectal cancer during the cohort expansion stage of the MATINS phase 1 and 2 study followed previously-reported early data from the ongoing dose escalation and safety stage of MATINS, which had now recruited four subjects with no safety concerns at 0.3 and 1.0 milligrams per kilogram dosing, and had moved to a three milligrams per kilogram dosing level.

All dosed patients had thus far shown a switch in their immune profile towards more immune activation, observed as an increase in CD8+ cells, an increased CD8/CD4 ratio, decreased regulatory T-cells, and a high appearance of mobile NK cells in the blood.

As it had previously reported, Faron had also received a tumour imaging report of a patient with colorectal cancer, which indicated "significant" shrinkage of lung metastasis.

The board said that positively, the patient had also shown a decrease in the tumour load marker carcinoembryonic antigen (CEA), which had normalised along with treatment.

In addition, the patient showed an increase in circulating B-cells, which could indicate an antibody-mediated response against the tumour.

It said the patient, whose tumour had been classified as microsatellite instability (MSI)-low, had previously been treated with six different anti-cancer drugs, which had all failed.

MSI-low colorectal patients represented around 90% of all colorectal cancers, and more than one million annual cases globally.

With that patient demonstrating a clinical partial response and expected immune switch, Faron said it was "confident" it had identified one group of patients who were thought to most likely respond to treatment, and demonstrate an immune switch in those immunosuppressive Clever-1-positive tumour associated macrophages.

"We are encouraged by the data gathered so far from the MATINS study, particularly the tumour imaging report from a colorectal patient in whom all other treatments have failed, which demonstrates a partial response according to RECIST already in nine weeks," said Faron chief executive officer Dr Markku Jalkanen.

"This information further supports our belief that Clevegen has the ability to function as a novel macrophage checkpoint immunotherapy for patients with currently untreatable solid cancers.

"Advancing MATINS into the cohort expansion stage later this year indicates our commitment to rapidly advance development of this potential therapy for patients in need of new treatment options."

Email this article to a friend

or share it with one of these popular networks:

• DIGG
• FACEBOOK
• STUMBLEUPON
• MIXX
• YAHOO BUZZ
• DELICIOUS
• REDDIT
• NEWSVINE