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.