PLYMOUTH MEETING, PA, USA I April 9, 2015 I Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today preliminary data showing that its INO-3112 DNA-based immunotherapy generated strong CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. INO-3112, an active immunotherapy that targets HPV 16 and 18 and simultaneously expresses IL-12, is designed to activate in vivo (in the body) immune responses to antigens from high risk HPV types and eliminate precancerous and cancerous cells displaying these antigens. The data, which are T cell measurements from the first four treated patients of this phase I/IIa study, are being presented today at the World Vaccine Congress 2015 by Inovio’s COO, Dr. Niranjan Y. Sardesai.
These positive results represent the first study and first report of T cell immune responses generated in cancer patients after treatment with an Inovio DNA immunotherapy. The magnitude and characteristics of these interim immune response data mirror immune responses previously observed in human studies of VGX-3100 for HPV-associated cervical dysplasia; in a placebo-controlled phase II study, strong T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “This initial data set from Inovio’s first cancer study provides encouraging evidence that we are on an important path to better optimized immunotherapy products. Regardless of whether it is an infectious disease, a precancer, or a cancer: the immune system uses the same mechanism to eliminate infected or mutated cells. In immune-oncology, it’s all about the T cells. Here we show in cancer patients that we can generate antigen-specific CD8+ killer T cell responses, which are essential to an effective immunotherapy.
“We look forward to completing our currently enrolling studies for HPV-associated head & neck and cervical cancers, completing the preparations for our planned phase III study for cervical precancer, and launching new studies for hepatitis B and prostate cancer that all rely on the same targeted T-cell-based killing activity.”
This open label study of HPV-caused head and neck cancer is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in up to twenty adults with HPV-positive head and neck squamous cell carcinoma. The study (NCT02163057) includes patients who are being treated with INO-3112 before and after resection of their tumor as well as patients being treated with INO-3112 after completion of chemotherapy and radiation therapy.
About HPV-Caused Head & Neck Cancer
Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. Head and neck cancers associated with HPV account for nearly 3 percent of all cancers in the United States and are twice as prevalent in men as in women. Incidence rates of HPV-caused head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing. By 2025, researchers believe that HPV will be the causative factor of 90% of all head/neck cancers.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
SOURCE: Inovio
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PLYMOUTH MEETING, PA, USA I April 9, 2015 I Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today preliminary data showing that its INO-3112 DNA-based immunotherapy generated strong CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. INO-3112, an active immunotherapy that targets HPV 16 and 18 and simultaneously expresses IL-12, is designed to activate in vivo (in the body) immune responses to antigens from high risk HPV types and eliminate precancerous and cancerous cells displaying these antigens. The data, which are T cell measurements from the first four treated patients of this phase I/IIa study, are being presented today at the World Vaccine Congress 2015 by Inovio’s COO, Dr. Niranjan Y. Sardesai.
These positive results represent the first study and first report of T cell immune responses generated in cancer patients after treatment with an Inovio DNA immunotherapy. The magnitude and characteristics of these interim immune response data mirror immune responses previously observed in human studies of VGX-3100 for HPV-associated cervical dysplasia; in a placebo-controlled phase II study, strong T cell immune responses were positively correlated with achievement of primary and secondary efficacy endpoints.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, “This initial data set from Inovio’s first cancer study provides encouraging evidence that we are on an important path to better optimized immunotherapy products. Regardless of whether it is an infectious disease, a precancer, or a cancer: the immune system uses the same mechanism to eliminate infected or mutated cells. In immune-oncology, it’s all about the T cells. Here we show in cancer patients that we can generate antigen-specific CD8+ killer T cell responses, which are essential to an effective immunotherapy.
“We look forward to completing our currently enrolling studies for HPV-associated head & neck and cervical cancers, completing the preparations for our planned phase III study for cervical precancer, and launching new studies for hepatitis B and prostate cancer that all rely on the same targeted T-cell-based killing activity.”
This open label study of HPV-caused head and neck cancer is intended to assess the safety, tolerability, and immunogenicity of INO-3112 in up to twenty adults with HPV-positive head and neck squamous cell carcinoma. The study (NCT02163057) includes patients who are being treated with INO-3112 before and after resection of their tumor as well as patients being treated with INO-3112 after completion of chemotherapy and radiation therapy.
About HPV-Caused Head & Neck Cancer
Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV is known to play a major role in the development of head and neck cancers, which include cancers of the oral cavity, oropharynx, nose/nasal passages and larynx. Head and neck cancers associated with HPV account for nearly 3 percent of all cancers in the United States and are twice as prevalent in men as in women. Incidence rates of HPV-caused head and neck cancers have been on the rise, especially HPV-associated oropharyngeal cancer in men, and are expected to continue growing. By 2025, researchers believe that HPV will be the causative factor of 90% of all head/neck cancers.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.
SOURCE: Inovio
Post Views: 212
