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Anti-MUC1 Vaccine
Anti-MUC1 Vaccine is a Cancer vaccine Biologic drug developed by Donald T. Weed, MD, FACS. It is currently in Phase 1 development. Also known as: Hiltonol.
Stimulates the immune system to recognize and attack cancer cells expressing the MUC1 glycoprotein antigen.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Anti-MUC1 Vaccine |
|---|---|
| Also known as | Hiltonol |
| Sponsor | Donald T. Weed, MD, FACS |
| Drug class | Cancer vaccine |
| Modality | Biologic |
| Phase | Phase 1 |
Mechanism of action
MUC1 is a transmembrane glycoprotein that is overexpressed and aberrantly glycosylated in many epithelial cancers. The vaccine aims to induce both humoral and cellular immune responses against MUC1-expressing tumor cells, potentially leading to tumor cell destruction through immune-mediated mechanisms.
Approved indications
Common side effects
Key clinical trials
- Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC (PHASE1, PHASE2)
- QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL (PHASE1, PHASE2)
- QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy (PHASE1, PHASE2)
- QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy (PHASE1, PHASE2)
- QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC (PHASE1, PHASE2)
- QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy (PHASE1, PHASE2)
- QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors (PHASE1, PHASE2)
- QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy (PHASE1, PHASE2)
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:
- Anti-MUC1 Vaccine CI brief — competitive landscape report
- Anti-MUC1 Vaccine updates RSS · CI watch RSS
- Donald T. Weed, MD, FACS portfolio CI
Frequently asked questions about Anti-MUC1 Vaccine
What is Anti-MUC1 Vaccine?
How does Anti-MUC1 Vaccine work?
Who makes Anti-MUC1 Vaccine?
Is Anti-MUC1 Vaccine also known as anything else?
What drug class is Anti-MUC1 Vaccine in?
What development phase is Anti-MUC1 Vaccine in?
Related
- Drug class: All Cancer vaccine drugs
- Manufacturer: Donald T. Weed, MD, FACS — full pipeline
- Also known as: Hiltonol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing