Clinical Trials

3rd Cancer Indication of Vaccine Candidate MEDI0457

Inovio MEDI0457 vaccine candidate treats multiple HPV-associated cancers

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Inovio Pharmaceuticals, Inc. announced that it achieved a 3rd indication milestone resulting from dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (INO-3112) in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor. 

In several on-going Phase 2 cancer-indication trials, MEDI0457 is being evaluated in combination with durvalumab, in patients with human papillomavirus (HPV) associated head and neck, cervical, anal, penile, and vulvar cancers. 

Dr. J. Joseph Kim, Inovio's President, and Chief Executive Officer said in a press release, "This Phase 2 milestone stresses the potential breadth of MEDI0457 in treating multiple HPV-associated cancers." 

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Additionally, Inovio is investigating VGX-3100, a DNA-based immunotherapy for the treatment of HPV-16 and HPV-18 infection and pre-cancerous lesions of the cervix (Phase 3) and vulva (Phase 2) and anal (Phase 2). 

VGX-3100 has the potential to be the first approved treatment for HPV infection of the cervix and the first non-surgical treatment for pre-cancerous cervical lesions. 

VGX-3100 works by stimulating a specific immune response to HPV-16 and HPV-18, which targets the infection and causes the destruction of pre-cancerous cells. 

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In a randomized, double-blind, placebo-controlled Phase 2b study in 167 adult women with histologically documented HPV-16/18 cervical HSIL (CIN2/3), treatment with VGX-3100 resulted in a statistically significantly greater decrease in cervical HSIL and clearance of HPV infection vs. placebo. 

VGX-3100 utilizes the patient's own immune system to clear HPV-16 and HPV-18 infection and pre-cancerous lesions without the increased risks associated with surgery, such as loss of reproductive health and negative psychosocial impacts. 

As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with small molecules, and chemotherapies across a range of tumors and stages of a disease. 

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor's immune-evading tactics and inducing an immune response.

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Inovio Pharmaceuticals, Inc. is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA-based immunotherapies and vaccines that transform the treatment and prevention of cancer and infectious disease. Visit Inovio for more information.