Data from First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0
Year: 2024
Type: other
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.
Authors: Joseph Markowitz, Michael Shamblott, Andrew S. Brohl, Amod A. Sarnaik, Zeynep Eroglu, Nikhil I. Khushalani, Christopher W. Dukes, Alejandra Chamizo, Marina Bastawrous, Edward T. Garcia, Ashraf Dehlawi, Pei-Ling Chen, Deanryan B. De Aquino, Vernon K. Sondak, Ahmad A. Tarhini, Youngchul Kim, Patricia Lawman, Shari Pilon-Thomas
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4401205369