Inovio begins Phase I trial of INO-5150 DNA immunotherapy to treat prostate cancer

The initiation of this human trial follows strong pre-clinical results revealing that INO-5150 generated healthy CD8+ T cell responses in animal studies including non-human primates.

The company noted that the immune responses generated by INO-5150 were similar in character to immune responses generated by its immunotherapy, VGX-3100, 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 new 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.

Inovio president and CEO Dr Joseph Kim said: "Inovio is focused on taking immunotherapy to the next level. Inovio is the only immunotherapy company that is generating T cells, in vivo, in high quantity that are fully functional whose killing capacity correlates with relevant clinical outcomes.

"With positive results from our phase II study of VGX-3100, Inovio’s active immunotherapy technology is a promising approach to treat various solid tumors by targeting the most important antigens for a particular tumor.

"Today’s launch of our SynCon prostate cancer immunotherapy builds on Inovio’s current trials for several difficult-to-treat cancers including head and neck, cervical, breast, lung, and pancreatic cancer."

The multi-centered Phase I trial is designed to evaluate the safety, tolerability, and immunogenicity of INO-5150 alone or in combination with INO-9012, the company’s DNA-based IL-12 immune activator.

The trial will also evaluate changes in PSA levels, an important biomarker in prostate cancer.