INO-5150 SynCon® immunotherapy for prostate cancer
MilestoneInitiate phase Ia/Ib clinical trial 2015
INO-5150 is Inovio’s dual-antigen SynCon® immunotherapy targeting prostate-specific membrane antigen (PSMA) and prostate-specific antigen (PSA). INO-5150 was generated by the creation of PSA and PSMA synthetic consensus antigens based on human and primate antigen gene sequences. By creating synthetic consensus gene sequences for the antigens coded by the immune therapy that slightly differ from native proteins, the intent of this immunotherapy design is to help break the body’s tolerance of self-made prostate cancer cells.
In 2013, Inovio entered into an exclusive worldwide collaboration with Roche to develop and commercialize Inovio’s prostate cancer DNA immunotherapy. This immunotherapy will be advanced into human trials based on strong positive preclinical data, including a simian study in which immunization with INO-5150 generated strong and robust T-cell immune responses, and a murine study in which treatment with INO-5150 induced potent antibody and T-cell responses. We intend to initiate a phase Ia/Ib clinical study in 2015.
In 2013, more than 238,000 new cases were diagnosed and over 29,000 men died from prostate cancer in the U.S. alone. The development of a new treatment for prostate cancer would be a significant medical advancement given that present treatment options (surgery, radiation and hormone deprivation), while somewhat effective, all carry deleterious side effects and are often not a long-term cure.
INO-5150 SynCon® Prostate Cancer Immunotherapy
Inovio plans to initiate a phase Ia/Ib clinical trial for INO-5150 in 2015. This study is intended to be conducted in a biochemically relapsed prostate cancer population and will potentially include additional new prostate cancer antigens that the team has been developing under the Roche/Inovio research collaboration and the integration of immunomodulatory drugs, including checkpoint inhibitors, from Roche’s pipeline.
INO-5150 SynCon® Prostate Cancer Immunotherapy
In a completed monkey trial, vaccinations with Inovio's SynCon® DNA immune therapy for prostate cancer generated robust T cell immune responses in monkeys. The level of T cell responses from this study was similar to the level of T cell responses observed from a previously conducted monkey study of VGX-3100, Inovio's immunotherapy for cervical cancer and dysplasia.
In a prior study in mice, INO-5150 immunization induced potent antibody and T cell responses, providing initial evidence that its concept for a therapeutic DNA vaccine comprising a broader collection of antigens, administered with Inovio's electroporation-based delivery technology, would improve the breadth and effectiveness of a prostate cancer immunotherapy.
Furthermore, the SynCon® DNA immunotherapy evaluated in this study was generated by the creation of PSA and PSMA synthetic consensus immunogens based on human and macaque sequences, which enabled the amino acid sequences of the antigens to differ slightly from the native protein. In humans, this novel approach may help the body's immune system to overcome its "self-tolerance" of cancerous cells created in the body by recognizing these cells as being foreign and mounting an immune response to clear these cells.
Prostate cancer is the second most frequently diagnosed cancer and the sixth leading cause of cancer death in males worldwide1. Key markers for prostate cancer are PSMA (prostate-specific membrane antigen), a protein found in prostate tissues, and PSA (prostate-specific antigen), a protein expressed almost exclusively by the prostate gland. PSA is present in small quantities in the blood of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. In those with prostate cancer, rising levels of PSA over time are associated with both localized and metastatic prostate cancer.
Because of PSA screening, almost 90% of patients are diagnosed when the cancer is localized to the prostate gland and its removal by surgery or radiotherapy will in most cases lead to a cure. Because of this almost 94% of U.S. patients choose treatment. Currently available therapies for aggressive prostate cancers involve surgery (i.e. radical prostatectomy), radiation therapy including brachytherapy, external beam radiation therapy, high-intensity focused ultrasound (HIFU), chemotherapy, oral chemotherapeutic drugs (Temozolomide/TMZ), cryosurgery, hormonal therapy, or some combination. Those treated have a high chance of sexual, urinary, and bowel side effects. Two-thirds of treated patients cannot get sufficient erections for intercourse; almost a third have urinary leakage.
Inovio believes there is significant opportunity for a safe, effective therapy with a favorable side effect profile to improve the lives of prostate cancer patients, and is seeking to advance its DNA immune therapy candidate INO-5150 into clinical trials.
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