PLYMOUTH MEETING, PA — INOVIO (Nasdaq: INO) moved closer to a potential commercial milestone in China after its licensing partner ApolloBio reported positive Phase 3 results for VGX-3100, an investigational DNA immunotherapy for cervical dysplasia, potentially positioning the therapy for regulatory review in one of the world’s largest healthcare markets.
The pivotal trial met its primary efficacy endpoint and demonstrated a favorable safety and tolerability profile, according to results released by ApolloBio. The data are expected to support a future regulatory submission in China for the treatment of HPV-16/18-associated cervical high-grade squamous intraepithelial lesions, a precancerous condition commonly known as cervical dysplasia.
The development carries financial implications for INOVIO under its licensing agreement with ApolloBio. The company is eligible to receive up to $20 million in milestone payments tied to regulatory approvals in specified territories, in addition to tiered royalties on future net sales if the therapy reaches the market.
“We believe these positive topline results for VGX-3100 reflect both the potential of our DNA medicine platform in HPV-related diseases and the power of partnerships to advance innovative DNA immunotherapies,” said INOVIO Chief Executive Officer Dr. Jacqueline Shea.
VGX-3100 is designed to generate an immune response against HPV types 16 and 18, the strains responsible for approximately 70% of cervical cancer cases worldwide. The therapy aims to clear persistent HPV infection while promoting regression of precancerous lesions, potentially reducing the need for surgical procedures such as loop electrosurgical excision procedures and cervical conization.
ApolloBio licensed rights to VGX-3100 in Greater China from INOVIO in 2018 and has identified cervical dysplasia as its first target indication. The company is also studying the therapy for other HPV-related precancerous conditions, including anal, perianal, vulvar and vaginal lesions.
The Phase 3 study was conducted across 22 tertiary hospitals in China and enrolled patients with HPV-16/18-associated cervical high-grade squamous intraepithelial lesions. Researchers evaluated a composite endpoint that measured both disease regression and clearance of HPV infection after 36 weeks.
ApolloBio reported that the trial achieved its predefined efficacy target and identified no significant new safety concerns.
The results add to growing evidence supporting therapeutic approaches for HPV-related diseases, an area where treatment options remain limited. While preventive HPV vaccines are widely available, there are currently no U.S.-approved therapeutic treatments for persistent HPV infection or cervical dysplasia.
According to the World Health Organization, cervical cancer was the fourth most common cancer among women globally in 2022, accounting for approximately 660,000 new cases and 350,000 deaths.
The positive trial outcome also provides another test of INOVIO’s DNA medicines platform, which combines synthetic DNA plasmids with the company’s proprietary CELLECTRA delivery technology. The platform is being developed across multiple disease categories, including infectious diseases, cancer, and HPV-related conditions.
INOVIO said it expects additional data from the study to be presented at future medical conferences and in peer-reviewed publications as ApolloBio advances toward a potential regulatory filing in China.
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