Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers

"The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.~Therapeutic Classification:~* Immunomodulatory Agent~Route of Administration:~* Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)~Mechanism of Action:~* Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.~Physiological Effect:~* Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses."