Inovio Pharmaceuticals (AMEX:INO) saw its stock surge this afternoon after it showed for the first time that its therapeutic synthetic vaccine VGX-3100 can kill cells changed by the human papillomavirus (HPV) into precancerous cervical dysplasias.
HPV is the leading cause of cervical cancer, and researchers have estimated the global prevalence of clinically pre-cancerous HPV infections at between 28 and 40 million.
The company has shown that the vaccine can drive what it called "robust immune responses" to antigens from high risk types of HPV.
But the fact that the treatment can also kill precancerous cells may ultimately lead to the regression or elimination of cervical dysplasia, a precancerous condition, or cervical cancer, the company said.
The vaccine maker is now assessing the ability of its DNA-based vaccine to treat cervical dysplasias caused by HPV infection in a global phase II trial. Specifically, the study will look to determine the vaccine's ability to reverse disease progression to cervical cancer.
Results from the phase I trial appeared today in a peer-reviewed journal, Science-Translational Medicine, Inovio noted.
"Today's milestone is convincing evidence that a DNA-based immune therapy can generate potent and durable T-cell responses in people," said company president and CEO, Dr. J. Joseph Kim, in a statement Wednesday.
"Our ongoing phase II efficacy trial is designed to show that the immune responses seen in this study, in particular the generation of killer T-cell responses, may reverse cervical disease caused by chronic HPV infection."
Dr. Kim further said that the type of T-cell killing activity seen in the new data provides a "growing foundation" for efficacy trials focused on the treatment of HPV-associated cancers, including cervical, head and neck, and anogenital.
The phase 1 study showed that 100 per cent of patients, or 18 of 18, had antigen-specific antibody responses to Inovio's vaccine, while 78 per cent showed T-cell responses to at least one antigen.
The company said that 91 per cent of patients who developed T-cell responses showed the presence of CD8+ T-cells capable of the type of killing activity seen, which is believed to be critical for treating cervical dysplasia and ultimately cancer caused by HPV.
Further, Inovio noted that analysis of T-cell immune data 24 weeks after the last immunization showed that the responses were still detectable in 86 per cent of evaluable patients.
For the phase II trial, Inovio is continuing to recruit patients, with the goal of enrolling 148 people with cervical dysplasias at multiple centres. The randomized, placebo-controlled study will look at the regression of cervical lesions.
Results from this later stage trial are expected late next year.
Every year, 510,000 cases of cervical cancer are diagnosed worldwide, and about 288,000 of the afflicted women die, Inovio said.
There is currently no therapeutic vaccine on the market to speak of as of yet, only preventative vaccines for HPV.
The company's VGX-3100 is designed to raise immune responses against the E6 and E7 oncogenes associated with HPV types 16 and 18, which transform HPV-infected cells into pre-cancerous and cancerous lesions.
Inovio's SynCon vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens, with clinical programs for cervical dysplasia, leukemia, the hep C virus, the flu and HIV.
Its stock soared over 21 per cent after the news, and was lately higher by over 15 per cent to 70.3 cents this afternoon.
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