Research started more than 14 years ago by the Spanish National Research Council (CSIC) has moved to the clinical phase with the authorization of the first human study of an innovative gene therapy for Alzheimer’s, according to the Spanish biotechnology company Tetraneuron announced this Thursday.
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The new strategy aims to act simultaneously on several mechanisms involved in neurodegeneration and opens a new path for patients with moderate dementia, a group with few therapeutic options.
The program is being developed by the Spanish biotechnology company Tetraneuron
The gene therapy TET-101, designed to address Alzheimer’s disease from a multifactorial perspective, has received authorization to begin its first clinical evaluation in patients.
The program is being developed by the Spanish biotechnology company Tetraneuron, a company born from research conducted around the E2F4 protein, involved in regulating essential processes for the functioning and survival of neurons.
The authorization was granted by Australian authorities, where the first human study of this therapy will be carried out at St Vincent’s Hospital in Melbourne. Meanwhile, the project continues to advance scientifically and regulatorily with a view to its development in Spain and Europe, the company reported.
Alzheimer’s disease is the leading cause of dementia worldwide and remains one of the greatest health challenges due to the lack of treatments capable of stopping or reversing neuronal deterioration in advanced stages.
Patients with more advanced deterioration still have few therapeutic options available”
Álvaro Pascual-Leone
Medical Director of Tetraneuron
In this context, TET-101 “is initially aimed at patients with moderate dementia caused by Alzheimer’s, a population for which therapeutic alternatives remain limited.”
According to the medical director of Tetraneuron, Álvaro Pascual-Leone, the advances achieved in recent years have mainly focused on the early stages of the disease, while “patients with more advanced deterioration still have few therapeutic options available despite the high medical, family, and social impact of the pathology.”
Unlike other approaches focused on specific targets such as beta-amyloid protein or tau protein, the strategy developed by this company “starts from a broader view of the disease.”
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Its goal is “to act on various interconnected biological processes that contribute to neurodegeneration, including neuroinflammation, oxidative stress, and loss of neuronal homeostasis.”
The therapy incorporates E2F4DN, a neuroprotective variant of the E2F4 protein designed to simultaneously influence different mechanisms involved in the progressive deterioration of neurons. Preclinical studies conducted so far have shown results supporting the advancement to the clinical phase.
More than 14 million invested
The leap to human evaluation is backed by accumulated funding exceeding 14 million euros since the company’s creation. Just during the last year, Tetraneuron obtained more than 4.3 million euros in public funding to boost its research programs in Alzheimer’s and Parkinson’s.
Of that amount, more than three million euros will be allocated to activities related to the clinical development of the Alzheimer’s program in Spain, in collaboration with HM Hospitals and the CIEN Foundation. Additionally, 1.3 million euros will be used to advance a program aimed at treating Parkinson’s in cooperation with the University of Navarra.
The CEO of Tetraneuron, Ángel Lucio Pereira, highlighted Spain’s scientific and clinical capacity to lead biomedical research projects of international scope and defended “the need to strengthen support for initiatives capable of transforming knowledge generated in laboratories into new therapeutic options for patients.”
Neurodegenerative diseases
Beyond Alzheimer’s, the company is working on developing a gene therapy platform based on biological mechanisms regulated by E2F4. The goal is to apply this knowledge to other neurodegenerative diseases that share processes related to brain inflammation, cellular stress, and progressive loss of neuronal function.
Parkinson’s currently constitutes the most advanced line of this expansion. The company has already obtained preclinical proof-of-concept results in this disease and trusts that the advances achieved in Alzheimer’s will accelerate future applications in other disorders associated with aging and neurodegeneration, the company concluded.
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