Faron Pharmaceuticals Ltd, a clinical stage biopharmaceutical company, and Abzena plc, a life sciences group providing services and technologies to enable development and manufacture of biopharmaceutical products, have entered into an agreement whereby Abzena will manufacture Clevegen, a novel therapeutic antibody being developed by Faron to reduce immune suppression in cancer. Clevegen may also have the potential to be used in other situations where there is an inadequate immune response, such as in chronic infections or during vaccination.
Clevegen was humanised by Abzena using its Composite Human Antibody technology. Under the agreement with Faron, Abzena will produce the Master Cell Bank and manufacture the antibody for clinical development under cGMP conditions. This is the first product produced using Abzena’s humanisation technology that will also be manufactured by Abzena following its acquisition of PacificGMP in San Diego, USA, in September 2015 to expand its manufacturing offering to phase I and II clinical studies.
Faron had previously signed an agreement with Selexis to obtain cell clones with high Clevegen production. This collaboration has progressed as planned and the best selected clone will be used by Abzena to produce the Master Cell Bank for Faron.
Markku Jalkanen, CEO of Faron Pharmaceuticals said, “We are very happy to collaborate with Abzena for GMP production of Clevegen to complete our pre-clinical development, and subsequently enter the clinic. We believe that Clevegen can bring an exciting new immune check point target to cancer therapies as it drives conversion of immune suppressive type 2 macrophages to immune active type 1 macrophages.”
John Burt, CEO of Abzena commented, “We are pleased to have this opportunity to enable Faron to progress this Abzena Inside antibody towards clinical development through this manufacturing agreement. Following the expansion of our business into the US last year, we have the ability to facilitate our partners' journeys from antibody humanisation to clinical trials.”
Faron´s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages. Clever-1 is involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is a humanised anti-Clever-1 antibody.
Clevegen, by binding Clever-1 prevents Tumour Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation into tumour supportive cell types. It therefore reduces suppression of the human immune system and converts the whole immune environment around a tumour to immune stimulating allowing a patient's own immune system to combat cancer, known as “immunotherapy”. Clevegen has a local tumour effect which also allows the cell-mediated immune response to attack infections in normal tissues and removal of immune suppression locally also limits risk of autoimmune reaction, a potentially severe side effect observed with some immune checkpoint inhibitors. The Directors of Faron believe that Clevegen is well differentiated from competing products as it specifically targets M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs which support immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity.