Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it has entered into a partnership with the AIDS Malignancy Consortium (AMC) to evaluate VGX-3100, Inovio’s immunotherapy for treating HPV-associated precancerous conditions in HIV-positive adult men and women. AMC will fund a Phase 2 clinical trial to evaluate the efficacy of VGX-3100 in adult men and women with human papillomavirus (HPV)-related high-grade anal dysplasia or squamous intraepithelial lesions (ASIL) and HIV. Recruitment is already ongoing for patients who are HIV-positive with histologically confirmed anal high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 and/or HPV-18. The multi-site Phase 2 study is planning to enroll approximately 75 patients who will receive four doses of VGX-3100. Financial details of the agreement were not disclosed.
Joel M. Palefsky, MD, Professor of Medicine, Division of Infectious Diseases, UCSF, and founder and chair of the HPV Working Group of the NCI AIDS Malignancy Consortium, said, “The incidence of anal cancer among HIV-positive men and women is unacceptably high. Better methods to treat the anal cancer precursor, known as anal high-grade squamous intraepithelial lesions (HSIL), are needed in an effort to prevent progression from HSIL to cancer. Given the encouraging results with VGX-3100 in treatment of cervical HSIL, the AMC looks forward to testing the immunotherapy for treatment of anal HSIL in this population.”
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “Expanding VGX-3100 to treat anal dysplasia represents a significant increase in commercial potential for our lead product. We thank the AMC for partnering with us to test the efficacy of VGX-3100 in a patient community where there is a great unmet need for a successful therapy. For these patients and others, Inovio is moving forward to become the ‘go-to’ immunotherapeutic solution provider for all major diseases caused by HPV, including cervical, vulvar and anal precancers.”
This open-label, multi-center Phase 2 study is designed to evaluate the safety and efficacy of VGX-3100 administered by intramuscular (IM) injection with CELLECTRA® delivery system in adult men and women who are HIV-positive with anal HSIL associated with HPV-16 and/or HPV-18. For additional information about the study, please visit www.clinicaltrials.gov (search identifier NCT03603808).
Separately, Inovio has already initiated a multi-center Phase 2 study designed to evaluate the safety and efficacy of VGX-3100 in 24 HIV-negative patients with anal HSIL associated with HPV-16 and/or HPV-18. The first patient was dosed in July.
Anal HSIL can lead to HPV-associated squamous cell carcinoma of the anus (SCCA). Anal cancer is uncommon in the general population, but its incidence is considerably increasing and is higher among HIV-positive men and women than in HIV-negative persons. The risk of SCCA among HIV-positive men has continued to increase even after the introduction of highly active antiretroviral therapy. Currently, rates of SCCA in HIV-positive men are higher than cervical cancer reported anywhere in the world. This trend is likely to continue with the aging of the HIV-positive population.