First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0
Molecular Cancer Therapeutics, 2024
Markowitz J., Shamblott M., Brohl A., Sarnaik A., Eroglu Z., Khushalani N., Dukes C., Chamizo A., Bastawrous M., Garcia E., Dehlawi A., Chen P., De Aquino D., Sondak V., Tarhini A., Kim Y., Lawman P., Pilon-Thomas S.
| Disease area | Application area | Sample type | Products |
|---|---|---|---|
Oncology Immunotherapy | Pathophysiology | Plasma |  Olink Target 96 |
Abstract
IFx-Hu2.0 was designed to encode part of the Emm55 protein contained within a plasmid in a formulation intended for transfection into mammalian cells. IFx-Hu2.0 promotes both adaptive and innate immune responses in animal studies. Furthermore, previous studies have demonstrated safety/efficacy in equine, canine, and murine species. We present the first-in-human study of IFx-Hu2.0, administered by intralesional injection into melanoma tumors of seven patients with stage III/IV unresectable melanoma. No dose-limiting toxicities attributable to IFx-Hu2.0 were observed. Grade 1/2 injection site reactions were observed in five of seven patients. IgG and IgM responses to Emm55 peptides and known melanoma antigens were seen in the peripheral blood, suggesting that IFx-Hu2.0 acts as an individualized “in situ vaccine.” Three of four patients previously refractory to anti-PD1 experienced clinical benefit upon subsequent anti-PD1–based treatment. Therefore, this approach is feasible, and clinical/correlative outcomes warrant further investigation for treating patients with metastatic melanoma with an immune priming agent.