The collaboration will focus on Inovio’s VGX-3100, which stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and causing destruction of precancerous cells.
Diagnostic company QIAGEN and Inovio Pharmaceuticals have partnered to co-develop a companion diagnostic to go along with Inovio’s DNA-based immunotherapy for cervical dysplasia caused by human papillomavirus (HPV).
The collaboration will focus on Inovio’s VGX-3100, a product candidate for HPV 16 and HPV 18 infection and precancerous lesions of the cervix (Phase III) and vulva and anus (Phase II). VGX-3100 stimulates a specific immune response to HPV-16 and HPV-18, targeting the infection and causing destruction of precancerous cells.
In a Phase IIb trial in 167 adult women with histologically documented HPV 16/18 cervical high-grade squamous intraepithelial lesions (HSIL), treatment with the drug resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection compared to placebo.
On May 6, the European Medicines Agency (EMA) granted VGX-3100 an Advanced Therapy Medicinal Product Certificate for quality and non-clinical data.
The drug has the potential to become the first treatment for HPV infection of the cervix and the first non-surgical therapy for precancerous cervical lesions linked to the human papillomavirus.
“We are pleased to support Inovio by developing a liquid biopsy-based companion diagnostic to identify patients who would benefit from VGX-3100, which has potential to make a dramatic difference in the detection of HPV infections and treatment of precancerous disease,” stated Peer M. Schatz, QIAGEN’s chief executive officer. “Our Sample to Insight workflows and experience in developing diagnostic solutions for Precision Medicine in immuno-oncology are well-suited to help Inovio address this large unmet medical need.”
The collaboration began in the discovery phase when Inovio chose QIAGEN Genomic Services to identify novel biomarkers that could be used in the assay. Inovio expects to make regulatory submissions for VGX-3100, and the companion diagnostic along with it, in 2021.
Earlier this week, Inovio inked a deal with Plumbline Life Sciences, based in Seoul, South Korea, to co-develop a novel animal health vaccine for African swine fever (ASF) virus. It will be developed using Inovio’s SynCon technology and delivered using CELLECTRA efficacy-enabling devices. Plumbline will fund all development and commercialization of the ASF vaccine. The two companies already have a licensing partnership in animal health, and Inovio holds about 15% equity ownership in Plumbline.
As part of that deal, Inovio will develop and evaluate the ASF vaccine in small animal models. Plumbline will test the vaccine in larger animal models, including in pig challenge models. Plumbline will commercialize the vaccine.
ASF is a highly contagious hemorrhagic viral disease of domestic and wild pigs. There is currently no approved vaccine and there is presently an outbreak in Asia that is threatening the agricultural economies of China, Vietnam and Korea, as well as other Asian countries. The disease is incurable in pigs, but harmless to humans. Official estimates indicate that 1 million pigs have been culled in China as a result of ASF infections, but 100 times more may be removed from China’s 440 million-count swine herd this year alone.
The U.S. Department of Agriculture projected in April that China would lose 134 million pigs to the disease, which is equivalent to the entire annual output of pigs in the U.S.
“We are extremely pleased to apply Inovio’s Synthetic Nucleics platform to develop a vaccine to combat this deadly pig virus,” stated Laurent Humeau, Inovio’s chief scientific officer. “Inovio has a track record of developing novel emerging infectious disease vaccines and we are pleased to work with Plumbline to further test and commercialize an ASF vaccine.”
