Product Description
Originally developed as a cancer vaccine, GV1001 is a 16-amino-acid peptide comprising a sequence from the human enzyme telomerase reverse transcriptase (TERT). Most cancers highly express TERT, and immunization with GV1001 aims to activate the immune system to recognize and kill cancer cells. GV1001 was approved in Korea for immunotherapy of pancreatic cancer, but failed to show efficacy in two international pancreatic cancer trials (Sourced from: https://www.alzforum.org/therapeutics/gv1001)
Mechanisms of Action: Vaccine
Novel Mechanism: No
Modality: Vaccine
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: GemVax & Kael
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Finland, France, Italy, Korea, Netherlands, Poland, Portugal, Spain, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Alzheimer Disease|Prostatic Hyperplasia
Phase 2: Paralysis|Progressive Supranuclear Palsy|Supranuclear Palsy, Progressive
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| GV1001-AD-CL3-S002 | P3 |
Not yet recruiting |
Alzheimer Disease |
2027-12-01 |
|
| GV1001-AD-CL2-007 | P2 |
Unknown Status |
Alzheimer Disease |
2026-01-31 |
|
| GV1001-PSP-CL2-011-E | P2 |
Active, not recruiting |
Progressive Supranuclear Palsy|Paralysis|Supranuclear Palsy, Progressive |
2025-11-01 |
|
| GV1001-PK-CL1-013 | P1 |
Recruiting |
Healthy Volunteers |
2025-08-31 |