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KLH Day 1
KLH Day 1 is a Biologic drug developed by Providence Health & Services. It is currently in Phase 1 development. Also known as: Immucothel..
KLH Day 1 is associated with a vaccine component, specifically a Hemocyanin 1 vaccine antigen, and is used in the treatment of various conditions including Advanced Cancer, Glioblastoma, and Rheumatoid Arthritis. The KLH vaccine antigen is administered as part of a monoclonal antibody treatment targeting OX40 in patients with these conditions.
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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 | KLH Day 1 |
|---|---|
| Also known as | Immucothel. |
| Sponsor | Providence Health & Services |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas (PHASE2)
- SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma (PHASE2)
- Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors (PHASE1)
- A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers (PHASE1)
- Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma (PHASE1, PHASE2)
- Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm (PHASE1)
- A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis (PHASE3)
- Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma (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:
- KLH Day 1 CI brief — competitive landscape report
- KLH Day 1 updates RSS · CI watch RSS
- Providence Health & Services portfolio CI
Frequently asked questions about KLH Day 1
What is KLH Day 1?
Who makes KLH Day 1?
Is KLH Day 1 also known as anything else?
What development phase is KLH Day 1 in?
Related
- Manufacturer: Providence Health & Services — full pipeline
- Also known as: Immucothel.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing