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IFx-Hu2.0
IFx-Hu2.0 is a Biologic drug developed by TuHURA Biosciences, Inc.. It is currently in Phase 2 development. Also known as: pAc/emm55.
IFx-Hu2.0 is an antibody that inhibits Complement C5, a mechanism that has been studied in various clinical trials for conditions such as cutaneous melanoma, Merkel cell carcinoma, and cutaneous squamous cell carcinoma. It has been compared to pembrolizumab in these trials, and is available for expanded access under the IFx-Hu2.0 Expanded Access Program.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IFx-Hu2.0 |
|---|---|
| Also known as | pAc/emm55 |
| Sponsor | TuHURA Biosciences, Inc. |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC) (PHASE1)
- Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma (PHASE2, PHASE3)
- Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (PHASE1)
- IFx-Hu2.0 Expanded Access Program
- IFx-Hu2.0 for the Treatment of Patients With Skin Cancer (PHASE1)
- pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IFx-Hu2.0 CI brief — competitive landscape report
- IFx-Hu2.0 updates RSS · CI watch RSS
- TuHURA Biosciences, Inc. portfolio CI
Frequently asked questions about IFx-Hu2.0
What is IFx-Hu2.0?
Who makes IFx-Hu2.0?
Is IFx-Hu2.0 also known as anything else?
What development phase is IFx-Hu2.0 in?
Related
- Manufacturer: TuHURA Biosciences, Inc. — full pipeline
- Also known as: pAc/emm55
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing