TETRANEURON – ReGenAD
ReGenAD is a clinical research project led by TETRANEURON to advance TET-101 towards its first evaluation in humans. With funding support from the Public-Private Collaborative Projects 2025 by Agencia Estatal de Investigación (AEI), ReGenAD is advancing TET-101, an innovative gene therapy designed to act on regulatory mechanisms involved in the progression of Alzheimer’s disease.
The project focuses particularly on patients with moderate Alzheimer’s disease, for whom therapeutic options remain very limited.
The Challenge
Alzheimer’s is a progressive neurodegenerative disease that causes memory loss, functional decline and dependency. Current treatments largely provide symptomatic and temporary relief. In addition, recently approved disease-modifying therapies target the early stages of the disease, leaving people with moderate Alzheimer’s with very limited treatment options.
The disease also involves several interconnected mechanisms, including amyloid and tau accumulation, neuroinflammation, synaptic dysfunction and neuronal loss. Therefore, targeting a single alteration may not be sufficient. New approaches are needed that can act on regulatory mechanisms influencing several disease processes.
The Project
The project will be carried out by a multidisciplinary consortium coordinated by TETRANEURON, Fundación HM Hospitales, and Fundación CIEN. TETRANEURON is responsible for the development of the gene therapy and brings the accumulated expertise behind TET-101. Fundación HM Hospitales will contribute its clinical expertise and will serve as the clinical trial centre. Fundación CIEN specialises in research into neurodegenerative diseases, biomarkers and neuroimaging.
ReGenAD will support the first clinical evaluation of TET-101, an AAV9 vector-based gene therapy for Alzheimer’s disease. The therapy incorporates hE2F4DN, a variant of E2F4 designed to resist pathological modification and be selectively expressed in neurons. In this way, it seeks to act on an upstream regulator involved in several processes associated with neurodegeneration.
The study will primarily assess the safety and tolerability of two dose levels of TET-101. In addition, it will generate clinical, cognitive, neuroimaging and biomarker data to help define the next stages of its clinical development.
The Impact
ReGenAD will generate the first human data on TET-101. The study will help characterise its safety, compare two dose levels and gather the evidence required to select the appropriate dose for future clinical phases. It will also explore whether the effects observed in non-clinical studies are reflected in clinical, biological and imaging indicators.
In the longer term, if clinical development confirms its potential, this approach could help preserve functional capacity in people with moderate Alzheimer’s disease and reduce the burden on their families and caregivers. The project will also strengthen Spain’s capabilities in advanced therapies, translational neuroscience and early-stage clinical trials. In addition, it will reinforce collaboration between a biotechnology company, a hospital centre and a public research institution.
El Resultado
The consortium has secured more than €1,281,853.50 in non-repayable funding through the Public-Private Collaborative Projects 2025 programme by Agencia Estatal de Investigación (AEI) to support the development of ReGenAD.
The project will run for 36 months, from September 2026 to August 2029. During this period, the consortium will work on manufacturing the medicinal product for clinical use, conducting the trial and evaluating its safety, tolerability and potential signs of activity through clinical data, biomarkers and neuroimaging.
The funding will support the manufacture of TET-101 for clinical use, enable its first evaluation in humans and generate the evidence required to support future stages of development.
Evolution Europe supported the consortium throughout the funding process, helping prepare a proposal designed to advance a gene therapy innovation from a strong preclinical foundation towards clinical evaluation.
