Therapeutic Candidate or Device

Tumor stem cell-targeted immunotherapy.

Indication

Metastatic melanoma.

Therapeutic Mechanism

Destruction of host tumor stem cells by adaptive humoral cellular immunity will eradicate the origin of melanoma which will extend patient survival.

Unmet Medical Need

There is no effective treatment for metastatic melanoma. This treatment is the only one to target tumor stem cells in melanoma patients.

Project Objective

Complete Phase 3 trial to support BLA approval.

Major Proposed Activities

• Enrollment of metastatic melanoma patients in phase 3 clinical trial.
• Manufacturing of tumor stem cell-targeted immunotherapy.
• Assessment of clinical safety and efficacy of the therapeutic candidate.

Metastatic melanoma is a disease with no effective treatment and estimated 9,710 deaths in USA in 2014. An effective treatment will keep afflicted individuals productive, enhance State tax revenues and defray the healthcare cost burden to taxpayers. It will also lead to robust industry developments in the fields of stem cell treatments and biomarker discovery, effectively leading to job creation and tax benefits to the State as a result of consumption of research and clinical goods and services.