Inovio evaluates the responses of immunotherapy in the treatment of HPV-related cancer head and neck -
Inovio Pharmaceuticals, Inc. (NYSE Amex: INO) announced today ' hui that it has launched a Phase I / IIa clinical trial to evaluate the safety, immunogenicity and clinical responses of its immunotherapy product, INO-3112 in the treatment of human papillomavirus (HPV) - associated head and neck cancer. INO-3112 is a lead product mix of active immunotherapy, VGX-3100 Inovio and its proprietary immune activator expressing interleukin-12 (IL-12). VGX-3100 is currently being evaluated in a randomized phase II efficacy for the treatment of dysplasia high grade cervical (pre-cancer).
In a phase I study of VGX-3100, Inovio has shown that immunotherapy produced high levels of durable immune responses of T cells, including CD8 + "killer" in 78% of patients in the study. These CD8 + T cells showed the functional capacity of killing target cells presenting the E6 and E7 antigens. In preclinical animal models, HPV immunotherapy Inovio demonstrated 100% protection against the HPV E6 and E7-expressing tumors and preventing or delaying the growth of these tumors. IL-12 immune enhancer owner, INO-012, has already been shown to improve specific immune responses of the CD4 antigen + and CD8 + T cells PENNVAX Inovio ® HIV DNA vaccine in a clinical trial. The inclusion of this immune activator based DNA in INO-3112 is designed to increase the production of specific HPV CD8 + T cells for the treatment of HPV-related cancers.
In this open study, called HPV-005, up to twenty adults with HPV-positive head and neck squamous cell carcinoma (ECCC) will be treated with INO-3112 and followed for safety and immune responses clinics. In a part of the study, up to ten patients will be treated with INO-3112 before and after resection of the tumor. In the second part of the study, up to ten patients will be treated with INO-3112 after the end of chemotherapy and radiotherapy. Each INO-3112 treatment will be administered using Inovio's CELLECTRA® delivery system.
In addition to assessing safety, the study will analyze the immune responses of T cells to INO-3112. Pre and post-immunotherapy tumor tissue will be analyzed to assess infiltration of T cells in the bed of the tumor and the tumor. Clinical responses characterized by anti-tumor effects, according to RECIST criteria, progression-free survival will also be measured.
The study will be conducted at the Abramson Cancer Center (ACC) at the School of Medicine Perelman (of PSOM) at the University of Pennsylvania, one of the cancer treatment center the first in the world and led by senior researcher Charu Aggarwal, MD, MPH, assistant professor of medicine in the division of hematology-oncology at the PSOM and ACC.
Dr. J. Joseph Kim, President and CEO of Inovio, said: "Initiating this head and neck cancer study is just the tip of the iceberg in our development plans immune therapy in oncology Onco-immunotherapy is all about T cells -. The same as our products have been shown to stimulate extremely well. We look forward to our next data cervical dysplasia unblinded phase II study on the efficacy and T-cell responses this summer. "
" We will also launch clinical studies on additional cancer to further characterize and expand the potential of our DNA immune therapy products and immune activators with their powerful capacity to generate and enable the highest levels of specific killer cells of the T antigen These include assays for INO-5150 for the prostate cancer with our pharmaceutical partner Q3 and INO-1400, our immunotherapy encoded for hTERT in the breast, cancer patients lung and pancreas later this year. our goal is to have the best and largest immunotherapies for cancer portfolio assets with the potential to find and destroy cancer cells, "said Dr. Kim.
human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV infection can lead to cervical dysplasia and cancer as well as cancers of the anogenital tract. head and neck cancer causing HPV is the fastest growing cancer in men and is expected to exceed the impact of HPV cervical cancers caused by the end of this decade. If proven effective INO-3112 could increase current therapeutic approaches to head and neck. the therapy today for oropharyngeal (head and neck) cancer is a combination of chemotherapy, radiotherapy and surgical resection. treatments have many potential side effects, including damage to the throat, which can impede the ability to speak and swallow.
VGX-3100 and INO-3112 for the treatment of diseases related to HPV Caused
lead product, VGX-3100 Inovio's immunotherapy based ' DNA for precancerous lesions and cancers caused by HPV. This product without an immune activator, is currently double-blind randomized, phase II evaluating its efficacy and immune responses against HPV-caused cervical dysplasia. INO-3112 combines this immunotherapy with IL-12 immune activator based DNA to further stimulate the immune response against head and neck cancer, cervical cancer and other cancers.
Inovio immune activators
immune enhancers can play a vital role in increasing antigen-specific immune responses such as those generated by DNA vaccines Inovio. Inovio the portfolio of patents granted, DNA-based immuno vary in their ability to activate and enhance the therapeutic T cells or preventing antibodies to modulate the type of immune responses generated by the vaccine, the impact of durability of the immune response, and drive immune responses towards sites of infection, such as mucosal surfaces. different immune enhancers can play a unique role in achieving desired immune responses generated by DNA immunotherapies and vaccines. In addition, while it has been shown certain cytokines and chemokines protein based for severe toxicity, probably because of their dosage levels and systemic administration, DNA and immune activators based immunotherapies Inovio come together to an injection site in order to allow local production by the body of cytokines or chemokines, as well as antigens which stimulate immune responses with modifiers advantages and toxic systemic effects disease.
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