Supplemental Table 1 from First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0

Markowitz, Joseph; Shamblott, Michael; Brohl, Andrew S.; Sarnaik, Amod A.; Eroglu, Zeynep; Khushalani, Nikhil I.; Dukes, Christopher W.; Chamizo, Alejandra; Bastawrous, Marina; Garcia, Edward T.; Dehlawi, Ashraf; Chen, Pei-Ling; De Aquino, Deanryan B.; Sondak, Vernon K.; Tarhini, Ahmad A.; Kim, Youngchul; Lawman, Patricia; Pilon-Thomas, Shari

doi:10.1158/1535-7163.26423950.v1

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Supplemental Table 1 from First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0

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posted on 2024-08-01, 07:44 authored by 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

Supplemental Table 1: Demographics; related/unrelated adverse events.

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National Cancer Institute (NCI)

United States Department of Health and Human Services

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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.

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Clinical Trial Results Immunotherapy Checkpoint blockade Skin Cancers Melanoma

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Supplemental Table 1 from First-in-Human Stage III/IV Melanoma Clinical Trial of Immune Priming Agent IFx-Hu2.0

Funding

National Cancer Institute (NCI)

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ARTICLE ABSTRACT

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