Allovectin^® (or Allovectin-7^®) 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, restores tumor-associated antigen presentation via MHC class 1, and boosts the immune response through a 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 recently 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.