Tenaya Therapeutics Doses First Patient in the MyPeak-1™ Phase 1b Clinical Trial of TN-201 for the Treatment of MYBPC3-Associated Hypertrophic Cardiomyopathy
Friday, October 06, 2023
Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the first patient has been dosed with TN-201 gene therapy for the treatment of Myosin Binding Protein C3 (MYBPC3)-associated HCM in the MyPeak-1 Phase 1b clinical trial at the Cleveland Clinic, Cleveland, Ohio. Tenaya anticipates sharing initial data from the MyPeak-1 trial in 2024.
TN-201 is Tenaya’s potential first-in-class adeno-associated virus (AAV)-based gene therapy designed to deliver a working, full-length copy of the human MYBPC3 gene to heart muscle cells. The working MYBPC3 gene is intended to restore normal levels of myosin-binding protein, which regulates the contraction and relaxation of the heart muscle. In preclinical studies, TN-201 halted disease progression and demonstrated significant and durable disease reversal and survival benefit following a single dose.
“MYBPC3 gene mutations are the most common genetic cause of HCM and people with MYBPC3-associated HCM are at increased risk for accelerated decline and serious complications associated with their condition,” said Milind Desai, M.D., MBA, Director at the Cleveland Clinic Hypertrophic Cardiomyopathy Center and Vice Chair, Heart Vascular Thoracic Institute, Cleveland Clinic, and an investigator for the MyPeak-1 Phase 1b clinical trial. “TN-201, a gene therapy for MYBPC3-associated HCM, offers the potential of a one-time treatment to correct the underlying genetic cause of disease and improve patient outcomes. We are pleased to participate in the first-in-human clinical trial of TN-201 to explore this new use of gene therapy treatment.”
About Tenaya Therapeutics
Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Leveraging its integrated and interrelated Gene Therapy, Cellular Regeneration and Precision Medicine platforms and proprietary core capabilities, the company is advancing a pipeline of novel therapies with diverse treatment modalities for rare genetic cardiovascular disorders and more prevalent heart conditions. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development. For more information, visit www.tenayatherapeutics.com.
Contacts
Michelle Corral
Vice President, Investor Relations and Corporate Communications
Tenaya Therapeutics
IR@TenayaThera.com
