Prakash Bhuyan, M.D., Ph.D. of INOVIO Pharmaceuticals @InovioPharma discusses the Phase 2 VGX-3100 results In patients with HPV-associated Anal Dysplasia.
INOVIO Pharmaceuticals, Inc. (NASDAQ: INO) today reported promising interim results from an open-label, Phase 2 study showing its lead DNA candidate VGX-3100 to be safe and successful in treating men and women with anal dysplasia, also known as high-grade squamous intraepithelial lesion (HSIL), a precancerous disease caused by high-risk human papillomavirus (HPV) forms 16/18. Of the 20 subjects that had findings at the time of data analysis, 50 percent (10 out of 20 subjects) showed clearance of precancerous lesions associated with HPV-16/18, and 75 percent (15 out of 20 subjects) showed an overall decrease in the number of lesions 6 months after treatment started. There were no reports of anal cancer reported in the study. The findings support the potential of VGX-3100 to effectively treat multiple HPV-related diseases and will be discussed at the annual meeting of the American Society for Colposcopy and Cervical Pathology (ASCCP) entitled: Preliminary results of an open-label Phase 2 Anal HSIL analysis of VGX-3100 for HPV16 and/or HPV-18 (HPV16/18).
Anal dysplasia or anal HSIL is an orphan disease in both immunocompetent and immunocompromised populations which affects men and women. Fewer than 1 in 5 individuals with precancerous dysplasia associated with HPV 16/18 show spontaneous resolution in one year. Anal HSIL could progress to anal cancer without adequate care. HPV 16/18 causes more than 90 per cent of all anal cancer, now considered one of the fastest-growing causes of cancer incidence and death. According to the American Cancer Society, anal cancer will claim the lives of more than 1,300 people in the U.S. and 8,590 news cases (5,900 in women and 2,690 in men) will be diagnosed in 2020. According to a report published in November 2019 in the National Cancer Institute Journal, the overall incidence of anal cancer rose by 2.7 percent per year from 2001 to 2015 and mortality jumped by 2.7 percent per year.
Prakash Bhuyan, M.D., Ph.D., INOVIO’s Vice President and Head of HPV Therapeutic Clinical Development, said “These initial proof-of-concept efficacy results show that VGX-3100 has the potential to enable the immune system to clear HPV 16/18 HSIL that cause precancerous anal dysplasia and are consistent with the results of our VGX-3100 Phase 2b efficacy study in high-risk HPV-associated precancerous cervical dysplasia.”