Senesco Technologies has signed a contract manufacturing deal for plasmids and a licensing agreement for a drug delivery technology as it seeks to get its Factor 5A treatment into clinical trials.
VGXI has been contracted to manufacture the Factor 5A plasmid for use in Senesco's combination therapy for treatment of cancer. Bruce Galton, president and CEO of Senesco, said: "VGX's manufacturing and technical expertise in producing plasmids for Senesco's planned toxicology study and ultimately our clinical trial led us to choose them. We are pleased to be working with a company that has such an outstanding reputation in the field."
The plasmid will be manufactured at VGX's facility in Texas, USA, which offers current good manufacturing practice (cGMP) compliant production in 500 and 1,000-litre fermenters. In addition the facility meets ISO requirements of class 8 to class 5 and has complete quality control (QC) testing and quality assurance (QA) release procedures in place.
VGX, which recently consolidated its contract manufacturing business into an affiliate called VGX International based in Korea, is also looking to expand its contract manufacturing operations through the construction of a 3,000-litre cGMP facility, said to be the largest of its kind in Asia.
The company's investment on plasmid DNA technology as a contract manufacturing is serving it well as the use of non-viral methods of delivering DNA-based therapies come to the fore. In May it inked a deal to produce a plasmid-based treatment for cystic fibrosis with a UK group. The separation of the CMO arm of the business allowed VGX to focus on developing its in-house portfolio of therapeutics, headed by HIV treatment Pictovir in Phase II testing.
Meanwhile, the delivery technology comes courtesy of Polyplus-transfection, with Senesco opting to use the company's in vivo-jetPEI. Polyplus has marketed the delivery technology as a cheap, synthetic alternative to virus-based gene delivery. Another advantage claimed by the company is that it does not suffer from the inflammatory immune responses associated with delivery using viral vectors.
Polyplus claims the system causes less aggregation of blood cells than its competitors, which can lead to restricted diffusion within a tissue, erythrocyte aggregation and microemboli. Through measures such as this Polyplus believes it has created a system capable of providing consistent, reproducible data. Commenting on the licensing agreement Galton said: "Polyplus' PEI technology is already being used in clinical oncology trials by other companies and we look forward to working with them and using their technology to deliver our Factor 5A technology."
The deals allow Senesco to move its treatment into clinical trials, following on from the positive results achieved in preclinical testing, which showed Factor 5A induced apoptosis in cancer cells.