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INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy In Treatment of Precancerous Anal Dysplasia Caused by HPV-16/18
DNA immunotherapy candidate VGX-3100 demonstrated resolution of HPV-16/18-associated precancerous anal lesions in 50% of treated patients six months after
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"DNA immunotherapy candidate VGX-3100 demonstrated resolution of HPV-16/18-associated precancerous anal lesions in 50% of treated patients six months after treatment\n Current standard of care for anal dysplasia typically requires surgical excision, electro-cautery or laser therapy, and without adequate treatment can progress to anal cancer\n\n\nPLYMOUTH MEETING, Pa., Dec. 9, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer and diseases associated with HPV, today announced positive Phase 2 efficacy results demonstrating that DNA medicine VGX-3100, the company's lead immunotherapy asset, showed resolution of HPV-16/18-associated precancerous anal lesions (HSIL) in 50% (11 of 22) of subjects six months following the start of treatment. The open label, single arm trial also showed VGX-3100 to be safe and well-tolerated in treating men and women with HPV-16-/18-associated anal dysplasia. INOVIO plans to pursue a registrational Phase 3 clinical trial for HPV-16-/18-associated anal dysplasia as well as to apply for rare and orphan disease designation for this indication in 2021.\nDr. Céline Bouchard, Gynecologist and Anoscopist at Centre Médical Santé Femme in Québec City, Canada and Coordinating Principal Investigator for the Phase 2 trial, said, \"Results of this trial are very promising and may offer a safe and efficacious new therapeutic option for patients suffering from this debilitating condition.\"\nVGX-3100 Phase 2 Anal Dysplasia Trial Highlights\nEnrolled 23 men and women 18 years of age or older. One subject discontinuation occurred due to an event related to a pre-existing condition of depression. Trial participants were men and women between 29 and 76 years of age at entry and other than having high grade anal squamous intraepithelial lesions were otherwise healthy. The relative proportion of anal dysplasia severity at baseline was skewed toward the more severe condition of AIN-3 disease (78% [18/23] of subjects). Subjects had a median of 4 lesions (range 2-7). Results are based on the demonstration of having no evidence of dysplasia from anal biopsy samples as assessed by two independent pathologists and non-detectability of HPV-16 or HPV-18 from lesion tissue using PCR-based testing...