The new OMS electroporation device enables to deliver short electric impulses to a tumour
Biotechnology company OncoSec Medical has secured CE mark approval for its electroporation device called GenPulse to treat solid tumours.
GenPulse, which is a next-generation go-to-market gene delivery device, is part of the OncoSec Medical System (OMS) electroporation device platform.
OncoSec is planning to commercialise the new gene electrotransfer device both in the US and European Union (EU).
OncoSec CMC and regulatory quality senior vice president Robert Ashworth said: “This CE certification is an essential regulatory milestone on OncoSec’s road to commercialization in Europe.
“The CE mark on our proprietary GenPulse generator represents the culmination of years of work and demonstrates that OncoSec has the capability to manufacture and develop a device that meets performance, quality and safety requirements in the EU.”
OncoSec stated the CE mark indicated the OMS electroporation device complies with Directives of the European Commission (EC) and can be commercialised within the 31-nation European Economic Area (EEA) and Switzerland.
The OMS electroporation device enables to deliver short electric impulses to a tumour, thereby helping to open pores in the membrane of cancer cells. It will allow to significantly increase the uptake of anti-cancer agents into these cells.
OncoSec Medical is a biotechnology firm engaged in the development of cytokine-based intratumoral immunotherapies to activate the body’s immune system to target and attack cancer.
Its immunotherapy investigational product candidate TAVO (tavokinogene telseplasmid) facilitates the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions.
Employing electroporation, the technology is designed to produce a controlled, localised expression of IL-12 in the tumor microenvironment.