The Development and Design of the MelVac platform and lead product, DC-MelVac

The sentinel discovery of the concept and technology can be traced to when Dr. Wallack began his research at the Wistar Institute in Philadelphia, PA, and developed a Cancer Vaccine against Melanoma from 1973 to 1977. This vaccine used a live vaccinia vaccine virus–augmented polyvalent melanoma cell lysates called Vaccinia Melanoma Oncolysate (VMO). The choice of vaccinia virus as an adjuvant for the preparation of VMO was made for two clinically sound reasons;

1. Vaccinia Virus enhanced the immunogenicity of tumors.
2. The safety profile of Vaccinia Virus was validated since it was used for mass immunizations against smallpox throughout the world.

The first cancer vaccine developed by Dr. Wallack was produced at the Institute Merieux in Lyon, France, and was tested in human melanoma clinical trials, first in Lyon, France and then in the United States. In the United States, the Phase I and Phase II trials were sponsored by the National Cancer Institute (NCI) and performed within the Southeastern Cancer Study Group (SECSG). The SECSG Phase I trial determined the limited toxicity and the effective dose of the VMO, and the SECSG Phase II trial evaluated both the immune responses and the clinical responses induced by the VMO in Stage III melanoma patients with more than five positive nodes in the draining lymph node area located near the primary tumor.

Furthermore, in the Phase II trial, VMO treatment resulted in an increase survival of highly aggressive Stage II melanoma resected patients when compared to historic controls. As a result, the VMO was approved for a Phase III randomized trial that was funded by the National Cancer Institute (NCI) and approved by the Federal Drug Administration (FDA). This surgical adjuvant Phase III clinical trial was performed between 1988- 1992 and was the first randomized, prospective, double–blind, multi-institutional, pharma-produced cancer vaccine trial in the world. Subset analysis indicated that male patients between the ages of 44 and 57 having one to five (1-5) positive microscopic or macroscopic lymph nodes showed a 37% difference in overall survival at the five (5) year time point when compared with controls. As a result of this male subset of patients that showed a positive response, Dr. Wallack and colleagues developed the more potent melanoma vaccine platform, “MelVac” for the next generation of melanoma trials.

The MelVac Patent:
United States Patent #7,015,205 B1