Tenaya Therapeutics is a biotechnology company focused on developing innovative therapies for heart disease through three primary platforms: Gene Therapy, Cellular Regeneration, and Precision Medicine. The Gene Therapy platform utilizes adeno-associated viruses (AAVs) to deliver healthy gene copies to heart cells, aiming to correct functional defects caused by genetic mutations. This approach is designed to address both genetic and non-genetic forms of heart disease. The Cellular Regeneration platform seeks to regenerate lost heart cells by using viral vectors to introduce specific gene combinations directly into the heart, potentially benefiting patients who have suffered from heart attacks or other conditions that lead to cardiomyocyte loss. 

Additionally, Tenaya's Precision Medicine platform leverages human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) to create disease models that facilitate the identification of new therapeutic targets and the validation of existing ones. This platform aims to enhance drug discovery by focusing on human biology rather than relying solely on animal models. The company has also invested in advanced drug development capabilities, including in-house AAV capsid engineering and a state-of-the-art manufacturing center, to ensure efficient production and delivery of their therapies. Through these integrated approaches, Tenaya Therapeutics aims to transform the treatment landscape for heart disease and improve patient outcomes.

United States

Tenaya Therapeutics, Inc. develops therapeutics for heart failure. It offers cellular regeneration platform, that enables in vivo reprogramming of cardiac fibroblasts into cardio myocytes by delivering proprietary transcription factors; gene therapy platform, that enables the targeted delivery of a payload to cardiac fibroblasts; and precision medicine platform, which provides personalized medicine approach to treat heart disease. The company was incorporated in 2016 and is based in South San Francisco, California.

Cardiovascular Diseases

Genetic Diseases

Tenaya Therapeutics

Hypertrophic cardiomyopathies

TN-201 – MYBPC3 Gene Therapy Program for Genetic Hypertrophic Cardiomyopathy (HCM)
In January 2023, Tenaya received notification from the U.S. Food and Drug Administration (FDA) that clinical testing of TN-201 may proceed based on the agency’s review of the company’s Investigational New Drug (IND) application. TN-201 is designed to deliver a fully functional MYBPC3 gene to restore normal levels of MyBP-C protein and thereby potentially halt disease progression and reverse the course of genetic HCM after a single dose.
Gene therapy

TN-201

Heart failure

TN-301 – Small Molecule HDAC6 Inhibitor for Heart Failure with Preserved Ejection Fraction (HFpEF)
Tenaya commenced dosing of healthy participants in the multiple-ascending dose (MAD) stage of its ongoing Phase 1 trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating oral doses of TN-301, a highly selective small molecule inhibitor of HDAC6 being developed for the potential treatment of HFpEF.
<ul class="font_8">
 <li>TN-301 was generally well tolerated during the single ascending (SAD) stage of Tenaya’s randomized, double-blind, placebo-controlled Phase 1 trial.</li>
 <li>Initial target engagement, measured by the biomarker of tubulin acetylation, was achieved at dose levels thought to be in therapeutic ranges based on preclinical experiments</li>
</ul>

TN-301 

Arrhythmogenic Right Ventricular Cardiomyopathy

TN-401 is designed to deliver a fully functional PKP2 gene to reverse disease and prevent arrhythmia after a single dose.

Tenaya Therapeutics

Company Details