Date: 2015-07-27
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Inovio Pharmaceuticals (USA - PA)
Product: INO-5150
Action
mechanism: immunotherapy product. INO-5150 is a new type of immunotherapy which targets both the prostate-specific antigen (PSA) and the and the prostate specific membrane antigen (PSMA). INO-5150 was generated using Inovio’s proprietary SynCon® process to enable significant production of PSA and PSMA antigens with genetic sequences differentiated from native human PSA and PSMA sequences. This patented approach is designed to help the body\'s immune system overcome its \"self-tolerance\" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I, open-label trial will evaluate the safety and immunogenicity of INO 5150 alone or in combination with INO-9012 when delivered intramuscularly (IM) followed by electroporation (EP) in men with biochemically relapsed prostate cancer. (NCT02514213)
Latest
news: * On July 27, 2015, Inovio Pharmaceuticals announced that it has initiated a phase I trial to evaluate Inovio’s DNA immunotherapy in men with biochemically relapsed prostate cancer. The launch of this human trial follows strong pre-clinical results revealing that INO-5150 generated robust CD8+ T cell responses in animal studies including non-human primates. The immune responses generated by INO-5150 were similar in character to immune responses generated by VGX-3100, Inovio\'s immunotherapy for human papillomavirus (HPV) that regressed pre-cancerous cervical lesions and eliminated HPV in a randomized, placebo-controlled phase II trial. INO-5150 is a novel SynCon® immunotherapy for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA), present in the majority of prostate cancer cells. This phase I study will evaluate the safety, tolerability, and immunogenicity of INO-5150 alone or in combination with INO-9012, Inovio’s DNA-based IL-12 immune activator. The multi-centered study will also evaluate changes in PSA levels, an important biomarker in prostate cancer.
