Private, South Korean-based biotech SillaJen has partnered up with contract research and manufacturing group ABL to supply its cutting-edge cancer vaccinia virus (which vaccinates against smallpox virus) candidate Pexa-Vec.
CDMO ABL, which has bases in France and Maryland, has penned a commercial manufacturing agreement for SillaJen's lead product candidate Pexa-Vec (formerly JX-594)--which is currently undergoing a Phase III open-label study of the oncolytic virus in patients with advanced liver cancer.
The theory goes that the use of an inert virus (which could be the poliovirus, the cold virus or herpes virus) works by delivering a cancer treatment direct to a tumor and have it kill the cancerous cells, but leave the healthy tissue alone.
There’s currently only one approved drug in the U.S. using this method, namely Amgen’s ($AMGN) oncolytic virus-based drug Imlygic (talimogene laherparepvec), which gained FDA approval for the treatment of melanoma lesions in the skin and lymph nodes last year. It is however only expected to reach peak sales of around $200 million a year.
A handful of other smaller biotechs, such as Canada’s Oncolytics Biotech, researchers at Duke University and the Pink Army, founded and run by former Amgen scientist Andrew Hessel, are also looking to create similar therapies.
Pexa-Vec is currently the most advanced product candidate from SillaJen’s Selective Oncolytic Vaccinia Engineering (SOLVE) platform.
The smallpox virus backbone of Pexa-Vec has of course been used in millions of people as part of a worldwide vaccination program for decades. The biotech said this strain targets cancer cells due to common genetic defects in these cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells.
Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. This GM-CSF expression is designed to complement the cancer cell lysis of the product candidate, therefore resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.
Its ongoing Phase III study--named the PHOCUS trial--is set to enroll 600 patients who have not received prior systemic treatment for their cancer.
"We are happy to enter into a long-term relationship with ABL Europe for commercial supply of our breakthrough oncolytic virus, Pexa-Vec," stated Georg Roth, senior VP of technical operations at SillaJen Biotherapeutics.
“This agreement will secure supply for our ongoing Phase III clinical trial as well as for commercial market demand worldwide.”
Financial details of the deal were not disclosed.
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