FDA has reviewed PrimeVax's IND-enabling data and permitted the trial to clinical stage.
Dendritic Cell vaccines have an established safety record in the history of cancer treatments. PrimeVax's DCs are the patient’s own cells matured outside the body, and are not subject to gene modifications in the same manner as TILs or CAR-Ts. Adverse reactions are typically limited to fever, nausea, fatigue, and rash at the infusion site. On rare occasions, more serious autoimmune reactions have occurred.
Dengue Virus has a natural history of 50 - 100 million infections per year. in the epidemiology of the disease, mortality rate is low in first infections (1/61,000 per Manson’s Tropical Disease). Secondary infections of a different serotype (e.g., DEN-1 after DEN-4), can cause severe hemorrhage and even life-threatening shock due to the strength of the body's own immune response. PrimeVax's dengue virus strain has been shown to have zero mortality history and also had a clinical history of manageable toxicities.
In the context of cancer research, PrimeVax’s safety and patient toxicity profile is lower than chemotherapy, and immunotherapeutic agents such as CTLA-4.