Evidence map›Paper›PMID 38657233›Full record

Trial reportMolecular cancer therapeutics2024

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

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 and 8 more

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Molecular cancer therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Targeted degradation of the HPV oncoprotein E6 reduces tumor burden in cervical cancer.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Article
  6. Article
  7. DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 3 institutions in 1 country.

Joseph MarkowitzDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0003-2490-5464
Michael ShamblottMorphogenesis, Inc, Tampa, Florida.ORCID 0009-0001-8052-1118
Andrew S BrohlDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-0071-0534
Amod A SarnaikDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-2337-5898
Zeynep ErogluDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-2307-7030
Nikhil I KhushalaniDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-3636-4143
Christopher W DukesDepartment of Immunology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-6322-1834
Alejandra ChamizoDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0009-0002-7673-9613
Marina BastawrousMorphogenesis, Inc, Tampa, Florida.ORCID 0009-0007-9319-4332
Edward T GarciaMorphogenesis, Inc, Tampa, Florida.ORCID 0009-0000-3072-8439
Ashraf DehlawiMorphogenesis, Inc, Tampa, Florida.ORCID 0000-0001-5932-1632
Pei-Ling ChenDepartment of Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0001-6025-4318
Deanryan B De AquinoDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0009-0001-1059-678X
Vernon K SondakDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0003-1090-484X
Ahmad A TarhiniDepartment of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-3193-9702
Youngchul KimDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0002-2307-0330
Patricia LawmanMorphogenesis, Inc, Tampa, Florida.ORCID 0009-0005-7173-7717
Shari Pilon-ThomasDepartment of Immunology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.ORCID 0000-0001-7785-3034
University of South Florida · USMorpho (United States) · USMoffitt Cancer Center · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
Nitric oxide immune dependent resistance mechanisms to anti-PD-1 therapyK08CA252164 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI MARKOWITZ, JOSEPH · 2021 to 2023
$707k
Bankhead Coley 23B05National Cancer Institute (NCI) KO8CA252164NCI NIH HHS K08 CA252164NCI NIH HHS P30 CA076292
6 · The paper itself

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.

Indexed as

MelanomaNeoplasm StagingAdultAgedCancer VaccinesFemaleHumansMaleMiddle AgedCancer Vaccines

Identifiers

PMID38657233
PMCPMC11292317
OpenAlexW4395068189

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.