First HPV immunotherapy! Inovio / dongfanglue vgx-3100 in the treatment of HPV related anal precancerous lesions phase II clinical completion of patients into the group!

August 20, 2019 / Biovalley BIOON / -- inovio Pharma, an American vaccine cancer immunotherapy company, recently announced that it has completed the open label of vgx-3100 in the treatment of anal precancerous lesions (for example, high-level squamous intraepithelial lesions of anus, anal HSIL), and the enrollment of 24 patients in the multicenter phase II clinical trial Vgx-3100 is a new DNA immunotherapy for human papillomavirus (HPV) 16 and 18 It has been developed for the treatment of HPV related precancerous lesions and the HPV infection that causes these lesions Currently, inovio is evaluating vgx-3100 in two key phase III Registration studies for the treatment of atypical hyperplasia of the cervix caused by HPV At the end of June this year, the first of these key studies, real-1, completed patient enrollment The purpose of this phase II study was to evaluate the safety and efficacy of vgx-3100 in the treatment of anal HSIL caused by HPV-16 and / or HPV-18 in men and women In a number of clinical studies, vgx-3100 has shown significant clinical efficacy In a concept validation phase II study for cervical atypical hyperplasia, 43 of the 107 patients treated with vgx-3100 achieved complete remission of high-grade cervical lesions and eliminated inherent HPV infection Dr J Joseph Kim, President and CEO of inovio, said: "we are very pleased to expand the target indications of vgx-3100 to treat rare and difficult to treat diseases, such as anal HSIL, which has a high recurrence rate and requires repeated operations In the fourth quarter, inovio plans to report preliminary efficacy and safety data from the phase II study The new immunotherapy is expected to effectively eliminate or delay surgery, which is a revolutionary therapy for patients with this highly unsatisfied disease " Anal HSIL or atypical hyperplasia is a rare disease and a precursor of anal cancer, which is estimated to cause more than 1280 deaths in the United States in 2019 Every year, there are nearly 20000 new cases of anal HSIL However, this is likely to be underestimated because the disease has no proven screening tests, nor is it registered or reported in the country At present, the only treatment for atypical anal hyperplasia is surgical resection, cauterization or laser treatment, but in the current treatment, 50% of patients recur within one year, and the recurrence rate is as high as 70% within three years Therefore, many patients with this disease need multiple treatments HSIL in the anus can lead to HPV associated squamous cell carcinoma of the anus (SCCA) Anal cancer is not common in the general population, but its incidence rate is significantly increased (increased 64% since 1992), and women are higher than men HIV positive men and women are higher than those of HIV negative Even after highly active antiretroviral therapy, the risk of SCCA in HIV positive men is still increasing It is estimated that there will be 8300 new cases of anal cancer in the United States in 2019 Vgx-3100 is the first HPV specific immunotherapy It is currently being developed as a non-surgical treatment product for the treatment of HPV 16 and HPV 18 infection as well as cervical precancerous lesions (stage III) and vulvar and anal precancerous lesions (stage II) Vgx-3100 can activate functional, antigen-specific, CD-8 T cells in vivo, clear the persistent HPV 16 / 18 infection, and recover cervical precancerous lesions Vgx-3100 has the potential to become the first approved treatment product for cervical HPV infection and the first non-surgical treatment program for cervical precancerous lesions This product will provide a very good opportunity for women to reduce the risk of cervical cancer without invasive surgical procedures It is worth mentioning that in February 2017, Beijing Oriental slightly reached a cooperation and authorization agreement with inovio to obtain the exclusive right to develop and commercialize vgx-3100 in Greater China (mainland China, Hong Kong, Macao, Taiwan) Last January, the two sides signed a cooperation Amendment Agreement Under the new agreement, Oriental will slightly advance $23 million (up from $15 million previously announced) and may pay another $20 million in the future when certain milestones are reached This cooperation includes the treatment and / or prevention of precancerous HPV infection and HPV driven atypical hyperplasia (including cervix, vulva and anus), and the exclusion of HPV driven cancer as well as the combination of vgx-3100 and other Immunoenhancers The agreement also provides for the possible inclusion of South Korea in the next three years Source of original text: inovio completed enrollment of its vgx-3100 open label phase 2 trial for treatment of HPV related high grade anal dysplasia