BioViva USA Receives Patent for Gene Therapy to Treat Cognitive Decline

Bainbridge Island, Washington-based biotechnology company BioViva USA, Inc., has announced the issuance of U.S. Patent No. 12,564,646, covering the use of gene therapy to treat age-related cognitive decline. The patent, titled "Treatment of Age-Related Cognitive Decline Using Genetically Modified Viral Vectors," was granted by the United States Patent and Trademark Office on March 3, 2026.

The patent encompasses the delivery of human Klotho (KL) and telomerase reverse transcriptase (hTERT) through genetically modified viral vectors, aiming to address conditions associated with dementia and Alzheimer's disease. Klotho is a naturally occurring protein linked to healthy aging and neurological function, while hTERT is involved in maintaining the length of telomeres, which protect the ends of chromosomes and are crucial for cellular longevity.

Elizabeth Parrish, CEO of BioViva USA, Inc., emphasized the significance of the patent: "This patent is a crucial milestone for BioViva and the broader effort to address the biology underlying age-related disease. Klotho has emerged as one of the most intriguing genes associated with healthy aging. Our goal is to develop therapies that tackle the underlying biological mechanisms of aging, rather than merely treating the diseases that arise later in life."

The patent includes multiple gene-delivery approaches, such as viral-vector platforms and different routes of administration. Specifically, the issued claims include the use of AAV8 and AAV9 vectors delivered intranasally to provide both Klotho and hTERT. This approach aims to enable cells to produce Klotho, potentially providing a more sustainable treatment compared to simply administering the protein.

Parrish added, "The issuance of this U.S. patent strengthens our intellectual property portfolio and creates opportunities for further research, licensing, development, and potential partnerships involving Klotho-based gene therapies. We are also pursuing patent applications in the European Union and China, which could further expand the geographic scope of our intellectual property protection."

BioViva USA, Inc. is dedicated to developing innovative therapies targeting the biological mechanisms of aging, with a focus on gene therapy and regenerative approaches. The company’s research and development strategy aims to address age-associated biological decline and extend healthy human lifespan. The patent issuance represents an important step in advancing the company’s efforts to combat age-related cognitive decline and other age-related diseases through targeted gene therapies.

While the issuance of the U.S. patent is a significant achievement, BioViva USA, Inc. remains mindful of the regulatory landscape and the challenges involved in bringing new therapies to market. As Parrish noted, "The issuance of a patent does not establish the safety or efficacy of a therapeutic product or guarantee regulatory approval. Our investigational approaches remain subject to applicable regulatory requirements and clinical development."

The company’s broader strategy includes addressing multiple hallmarks of aging, with the ultimate goal of extending healthy human lifespan. Pending patent applications in the European Union, China, and other jurisdictions could further expand the geographic scope of the company’s intellectual property protection, potentially opening up opportunities for global research and development partnerships.