INO-5150 SynCon® immunotherapy for prostate cancer


Preclinical

  • Prostate cancer

 

Milestone

Initiate phase I 3Q 2014

Prostate cancer image

Description
INO-5150 is Inovio’s dual-antigen SynCon® vaccine 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 vaccine that slightly differ from native proteins, the intent of this vaccine design is to help break the body’s tolerance of self-made prostate cancer cells.

Development Status

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 vaccination 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 I clinical study in 3Q 2014.

Disease State
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.



Clinical Trials

Clinical Trials

Inovio plans to initiate a phase I clinical trial for INO-5150 in 3Q 2014.

Study Data

Study Data

INO-5150 SynCon® Therapeutic Prostate Cancer Vaccine

In a completed monkey trial, vaccinations with Inovio's SynCon® therapeutic DNA vaccine 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 Phase II-stage therapeutic vaccine for cervical cancer and dysplasia. In a Phase I study, VGX-3100 generated best-in-class T cell responses, which were persistent through the complete study duration of nine months.

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 vaccine 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.

More Information

More Information

INO-5150 SynCon® Therapeutic Prostate Cancer Vaccine

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 vaccine candidate INO-5150 into clinical trials.

  1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D (2011). "Global cancer statistics". CA: A cancer journal for clinicians 61 (2): 69-90. doi:10.3322/caac.20107. PMID 21296855