First HPV immunotherapy! Inovio / dongfanglue vgx-3100 in the treatment of HPV related cervical precancerous lesions stage III clinical completion of the patients into the group!

06 / 28 / 2019 Biovalley BIOON/ -- Inovio Pharma, an American vaccine cancer immunotherapy company, recently announced that it has completed the enrollment of 198 participants in the key phase III registration trial (REVEAL 1) of VGX-3100 Vgx-3100 is a new DNA based immunotherapy for cervical atypical hyperplasia caused by human papillomavirus (HPV) Atypical hyperplasia of the cervix belongs to precancerous lesions, if not treated in time, it may develop into cervical cancer If approved, vgx-3100 will be the first immunotherapy and non-surgical treatment for women with advanced cervical atypical hyperplasia 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 Dr J Joseph Kim, President and CEO of inovio, said: "this is an important milestone for the company, because it brings inovio closer to providing innovative treatment for women with cervical atypical hyperplasia For these women, surgery is the only choice now The U.S and Europe represent large markets that need to provide non-invasive treatment options for women, and we are now focusing on the inclusion of subjects in a confirmatory study (real 2) in order to submit a U.S FDA listing application in 2021 " Inovio's phase III project is evaluating the efficacy of vgx-3100 in reversing cervical HSIL (high-grade squamous intraepithelial lesions, a direct precursor to cervical cancer) and eliminating HPV infection that causes these lesions The real studies in this project are all prospective, randomized (2:1), double-blind, placebo-controlled trials to evaluate cervical HSIL confirmed by HPV 16 / 18 positive biopsy in adult women, also known as cervical intraepithelial neoplasia (CIN) 2 or 3 The purpose of real 1 is to provide safety data for at least 198 subjects treated with vgx-3100 for one year The confirmatory phase III trial (real 2) is currently recruiting subjects to provide safety data for at least 198 subjects for one month The primary end points of the phase III study were resolution of HSIL in the cervix and virological clearance of HPV16 and / or HPV18 in the cervix These studies will evaluate the cervical tissue changes 9 months after the start of vgx-3100 three dose regimen (0 month, 1 month, 3 months) Secondary endpoints included safety, tolerability, CIN 2 / 3 return to CIN 1 or normal, virological clearance of HPV, efficacy measured by non progression cancer, and clearance of HPV from non neck anatomic sites Prakash bhuyan, MD, director of clinical development of vgx-3100, said: "the completion of the enrollment of real 1 subjects proves that our outstanding researchers and their teams are committed to developing a non-manual treatment for cervical highly atypical hyperplasia across 19 countries worldwide "Inovio previously reported that in the phase IIB randomized, placebo-controlled trial, vgx-3100 eliminated highly atypical hyperplasia in nearly 50% of women In 80% of the women whose atypical hyperplasia was eliminated, HPV infection was also eliminated by vgx-3100 Further data analysis showed that the combination of HPV test and cervical cytology (cervical smear test) could predict the elimination of highly atypical hyperplasia and HPV early in the treatment period In addition, inovio continues to work with Qiagen to develop pre-treatment biomarker detection methods, which may provide the ability to predict the clinical response of vgx-3100, ultimately helping patients choose and doctors guide patients' care These pre-treatment biomarkers can identify patients who are most likely to respond to vgx-3100 treatment, thus improving the absolute efficacy of the product In February 2017, Beijing Dongfang Lue entered into a cooperation and authorization agreement with inovio to obtain the exclusive right to develop and commercialize the 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 Original source: inovio website