US-based Inovio Pharmaceuticals (NASDAQ: INO) and China-based ApolloBio Corp. (NEEQ:430187) have announced positive data from the Phase III Reveal 2 study for the DNA therapeutic vaccine VGX-3100 (known as ABC-3100 in China). The two firms are co-developing VGX-3100 under a 2018 licensing deal, with ApolloBio holding development and commercialization rights for the Greater China territory. The US FDA has previously indicated that VGX-3100 would require further trials after Reveal 2 to be eligible for a biologics license application.
Study Details and Results
Reveal 2 is the second Phase III, global multi-center trial assessing VGX-3100 for efficacy, safety, tolerability, and immunogenicity in treating HPV-16/18-related cervical high-grade squamous intraepithelial lesions (HSIL). A total of 203 patients with grade 2 or 3 cervical squamous intraepithelial neoplasia (CIN) were enrolled in the study. Participants received a single injection of VGX-3100 or placebo with an electric pulse at 0, 1, and 3 months, with observations lasting 40 weeks after the first administration.
While the investigational biomarker-selected population did not achieve statistical significance, the trial results did achieve statistical significance in the all-participants population for the endpoint of lesion regression and viral clearance. The response rate was 27.6% for VGX-3100 compared to 8.7% for placebo (p=0.001). The summary and analysis results of the Reveal 1 and Reveal 2 studies show that VGX-3100 has reached a statistically significant difference in all study populations and biomarker-positive patients, demonstrating good safety and tolerability, and the ability to induce antigen-specific T cell reactions in peripheral blood and cervical tissue.
ApolloBio’s Observations
ApolloBio noted that studies conducted in China showed that VGX-3100 produced a significantly higher response rate in Chinese patients than in the Reveal 1 and Reveal 2 studies, with response rates of up to 70% in certain subgroups. This suggests that the vaccine may have particular efficacy in the Chinese patient population, potentially offering a significant treatment option for HPV-related cervical lesions.-Fineline Info & Tech
