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DRUG:

IFx-2.0

i
Other names: IFx-2.0, IFx-Hu2.0, pAc/emm55, autologous whole-cell ImmuneFx cancer vaccine, emm55 Streptococcal antigen pDNA, pDNA intralesional cancer vaccine
Associations
Trials
Company:
TuHURA Bio
Drug class:
Immunostimulant
Related drugs:
Associations
Trials
2ms
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC) (clinicaltrials.gov)
P1, N=9, Recruiting, TuHURA Biosciences, Inc. | Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Oct 2025
Enrollment open • Trial initiation date • Checkpoint inhibition
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Keytruda (pembrolizumab) • IFx-2.0
2ms
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma (clinicaltrials.gov)
P2/3, N=118, Recruiting, TuHURA Biosciences, Inc. | Initiation date: Jun 2025 --> Oct 2025 | Not yet recruiting --> Recruiting
Enrollment open • Trial initiation date • Checkpoint inhibition
|
Keytruda (pembrolizumab) • IFx-2.0
7ms
New P2/3 trial • Checkpoint inhibition
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Keytruda (pembrolizumab) • IFx-2.0
7ms
New P1 trial • Checkpoint inhibition
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Keytruda (pembrolizumab) • IFx-2.0
1year
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov)
P1, N=23, Completed, TuHURA Biosciences, Inc. | Active, not recruiting --> Completed
Trial completion
|
IFx-2.0
over1year
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov)
P1, N=23, Active, not recruiting, TuHURA Biosciences, Inc. | Trial completion date: Mar 2024 --> Aug 2024
Trial completion date • Metastases
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IFx-2.0
almost2years
Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov)
P1, N=23, Active, not recruiting, TuHURA Biosciences, Inc. | Trial completion date: Dec 2023 --> Mar 2024 | Recruiting --> Active, not recruiting
Enrollment closed • Trial completion date • Metastases
|
IFx-2.0
2years
Immune priming IFx-Hu2.0 promotes antibody responses necessary for anti-PD1 responses in PD-1 refractory melanoma patients (SITC 2023)
"Conclusions Antigenic Emm55-derived peptides provoke individual immune responses via an antigen/interferon-dependent process in those patients with the longest survival after subsequent anti-PD1 treatment. Subsequent studies are being planned for the clinic."
Clinical
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nCounter® PanCancer IO 360™ Panel
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IFx-2.0
almost5years
Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. (PubMed, Cancer Immunol Immunother)
pAc/emm55 treatment combined with PD-1 blockade enhanced anti-tumor immune response and improved systemic anti-tumor immunity. Together, these strategies may lead to improvements in the treatment of patients with melanoma.
Preclinical • Journal
|
CD8 (cluster of differentiation 8)
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IFx-2.0
over5years
[VIRTUAL] Trial in progress: IFx-Hu2.0 (plasmid DNA coding for Emm55 streptococcal antigen in a cationic polymer) phase I first in human study for unresectable stage III or stage IV cutaneous melanoma (AACR-I 2020)
Success of the study is defined as being able to treat 5/6 subjects without DLT at 28 days. Three of the six planned trial subjects have been enrolled as of January 2020 (Clinical trial registry number: NCT03655756).
P1 data
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • SOX10 (SRY-Box 10) • FOXP3 (Forkhead Box P3)
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IFx-2.0