The deal allows ApolloBio to develop VGX-3100 as a non-surgical treatment and prevention for HPV infections and HPV-related pre-cancerous lesions, but not for HPV-related cancers or combinations of VGX-3100 with other immunotherapies. ApolloBio’s up-front and near-term payments and investments will rise to $50 million.
Dr. J. Joseph Kim, Inovio’s president and CEO, said in a news release that the accord opens up the huge Chinese market — which includes Hong Kong and Macao — for his company’s first Phase 3 drug.
“We believe that ApolloBio is a strong partner that brings significant capabilities and expertise relating to product development, the Chinese regulatory landscape, and the healthcare market in China,” he said.
VGX-3100, a DNA vaccine, functions by targeting HPV types 16 and 18, which activates functional and specific CD8 T-cells to clear pre-malignant or malignant cells infected with the virus.
In July, 2014, Inovio completed a randomized, double-blind, placebo-controlled Phase 2 trial (NCT01304524) of VGX-3100 in women with cervical pre-cancerous lesions associated with HPV types 16 or 18. The study compared the intramuscular injection of VGX-3100 followed by electroporation (tiny electric currents that open the cell’s membrane and allow the DNA molecules to enter).
VGX-3100 was found to have promising clinical efficacy, without the side effects associated with surgical excision of the lesions.
“We are delighted to begin 2017 with a strategic collaboration with Inovio. VGX-3100 is the world’s first therapeutic vaccine being developed for HPV pre-cancers,” said Dr. Weiping Yang, ApolloBio’s CEO, adding that “this collaboration, license and equity investment marks our determination to introduce late-stage innovative new drugs to meet severely unmet medical needs” throughout the region.
The deal could potentially include South Korea three years following the effective date. ApolloBio will fund all clinical development costs within the licensed territory, and will pay Inovio an additional $20 million upon meeting certain U.S., Chinese and Korean regulatory milestones.
HPV is the most common sexually transmitted infection. It’s also the leading cause of cervical cancer, which kills more than 250,000 women every year worldwide. Of the 300 million women currently infected with HPV, 500,000 are diagnosed with cervical cancer annually. Two types of the virus, HPV 16 and HPV 18, cause 70 percent of cervical cancer cases.