GemVax & KAEL

GemVax & KAEL is a clinical-stage biopharmaceutical company based in Korea, dedicated to developing proprietary therapeutics for neurodegenerative diseases. Its lead compound, GV1001, is a synthetic peptide composed of 16 amino acids that has been validated for multiple actions related to neurodegenerative diseases, including cytotoxicity, neuroinflammation, and oxidative stress. The company is conducting a Phase II clinical trial in Korea to evaluate the efficacy and safety of GV1001 in patients with Progressive Supranuclear Palsy (PSP), with preparations underway for a global PSP clinical trial. GV1001 has received FDA Fast Track Designation for PSP treatment.

GemVax & KAEL is a clinical-stage biopharmaceutical company based in Korea. Its history includes the following milestones: In 2013–2018, announcement of Phase 3 clinical trial results for TeloVac (UK) and execution of a management rights transfer agreement. In 2019–2021, FDA IND approval for a Phase 2 clinical trial for Alzheimer's disease (US), announcement of Phase 2 clinical trial results for Alzheimer's disease (KR), and announcement of Phase 3 clinical trial results for pancreatic cancer (KR). In 2022, IND approval for a Phase 3 clinical trial for Alzheimer's disease (KR) and initiation of a global Phase 2 clinical trial for Alzheimer's disease (US). In 2023, IND approval for a Phase 2 clinical trial for Progressive Supranuclear Palsy (KR), EU IND approval for a Phase 2 clinical trial for Alzheimer's disease (7 European countries), signing of a domestic license agreement with Samsung Pharm Co., Ltd. for Alzheimer's disease drug development, announcement of Phase 3 clinical trial results for benign prostatic hyperplasia (KR), and approval of IND for clinical extension of a Phase 2 clinical trial for Progressive Supranuclear Palsy (KR). In 2024, FDA IND approval for a Phase 2 clinical trial for Progressive Supranuclear Palsy (US), Orphan Drug Designation of GV1001 by the MFDS for the treatment of Progressive Supranuclear Palsy (KR), completion of patient recruitment for a global Phase 2 clinical trial for Alzheimer's disease (US, EU), and announcement of topline results for a Phase 2 clinical trial for Progressive Supranuclear Palsy (KR). In 2025, Orphan Drug Designation of GV1001 by the FDA for the treatment of Progressive Supranuclear Palsy (US), Orphan Drug Designation of GV1001 by the EMA for the treatment of Progressive Supranuclear Palsy (EU), Fast Track Designation of GV1001 by the FDA for the treatment of Progressive Supranuclear Palsy (US), and announcement of topline results for a Phase 2 clinical trial for Progressive Supranuclear Palsy (KR).

A global leader in innovative drug development

• GV1001

  A synthetic peptide composed of 16 amino acids, validated for multiple actions related to neurodegenerative diseases, including cytotoxicity, neuroinflammation, and oxidative stress.

1. 1| GemVax & KAELgemvax.com
2. 2| GemVax & KAELgemvax.com
3. 3| GemVax & KAELgemvax.com
4. 4GemVax & KAEL (South Korea)wikidata.org