Shares in Inovio Pharmaceuticals (NSDQ:INO) jumped more than 10% after it announced that it is launching a Phase III clinical study of its investigational DNA immunotherapy candidate designed to treat cervical dysplasia caused by human papillomavirus.
The moves comes after the FDA lifted a hold that it placed on the clinical program in October last year. At the time, the FDA requested data to support the shelf-life of the disposable parts of Inovio’s Cellectra electroporation device.
Inovio plans to evaluate the efficacy of VGX-3100, its first immunotherapy, in regressing cervical high-grade squamous intraepithelial lesions – a direct precursor to vervical cancer – and its ability to eliminate the HPV infection that causes the lesions. Data from the pivotal trial will support the potential licensure of VGX-3100 as the 1st immunotherapy for this disease, according to Inovio.
The company’s plasmid DNA immunotherapy is injected intramuscularly, followed by electroporation using Inovio’s Cellectra delivery device. Cellectra uses a pulse of electricity to briefly open the pores in a cell’s membrane and introduce the DNA.
Inovio’s Phase III Reveal program is composed of 2 studies, the company reported, and is slated to enroll nearly 400 patients in total.
The primary endpoint of both studies is regression of cervical HSIL and virologic clerance of HPV-16 and/or HPV-18 in the cervix.
Researchers plan to assess cervical tissue changes after 9 months. The secondary endpoints include safety, tolerability and efficacy measured by non-progression to cancer.
“Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem,” chief medical officer Dr. Mark Bagarazzi said in prepared remarks. “Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month.”
“Initiating our Reveal Phase III program marks a milestone for Inovio, for the next generation of DNA-based immunotherapies, and for women’s health,” president & CEO J. Joseph Kim added. “Combining this 1st Phase III program with our previously announced phase 2 clinical trial of VGX-3100 for HPV-related vulvar neoplasia and our checkpoint inhibitor-based combination study with MedImmune/AstraZeneca targeting HPV associated cancers, Inovio is well positioned to comprehensively treat HPV-associated diseases across the continuum of HPV infection through to cancer in both men and women. Adding our recently announced collaborative immuno-oncology combination studies with Regeneron and Genentech, 2017 is a transformative year that is laying the foundation for multiple opportunities for important efficacy data.”
