Cancer immunotherapies have moved from the laboratory to the marketplace with the U.S. approval of the first human cancer immunotherapeutic (Provenge^®) in 2010. In early 2011, another immunotherapeutic, YERVOY™ (ipilimumab; Bristol-Myers Squibb Company), was approved by the FDA for the treatment of patients with metastatic melanoma based on a significant survival improvement of 4 months compared to a control group receiving a gp100 vaccine. BMS also announced recently that YERVOY™ at a higher dose and in combination with chemotherapy met the primary endpoint of improving overall survival in previously-untreated patients with metastatic melanoma.

Allovectin^® is a first-in-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. Allovectin^® is a plasmid-based immunotherapeutic expressing two genes (HLA-B7 and β2 microglobulin) that together form an MHC class 1 complex. Allovectin^®'s lead indication will be first-line treatment for Stage III and IV melanoma, where it is intended to provide advantages over current first-line therapies: improved efficacy, better safety profile, and simple outpatient administration. Allovectin^® has a convenient presentation as a single vial stored refrigerated and a conventional needle and syringe administration into a lesion. The product is used in a physician's office in an outpatient setting and it does not require any pre- or post-medication. Allovectin^® has demonstrated an excellent safety profile in multiple clinical trials at various doses.

Allovectin^® has a unique set of mechanisms of action: it teaches the immune system to recognize and destroy tumor cells through an allogeneic anti-tumor response, restoration of tumor-associated antigen presentation via MHC class 1, and boosts the immune response by the lipid/DNA-induced danger signal. A Phase 3 pivotal trial designed to prove superiority versus the current first-line chemotherapies in patients with metastatic melanoma has completed full patient (390) enrollment with sites primarily in the U.S. and Europe. The trial design was accepted by FDA under a Special Protocol Assessment (SPA). Additionally, Allovectin^®'s mechanisms of action are applicable to any type of accessible, immunoreactive solid tumor, providing multiple follow-on indications, such as breast cancer, prostate cancer, and head and neck cancer. Vical has obtained orphan drug and fast track designations in the U.S. and is seeking a commercialization partner for all the major markets in North America and Europe.