An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Tenaya Therapeutics (TNYA) announced that its TN-401 gene therapy program for arrhythmogenic right ventricular cardiomyopathy (ARVC) will present preclinical results at the Heart Rhythm Society's annual meeting on May 1, 2022. TN-401 addresses PKP2 gene mutations affecting over 70,000 patients in the U.S., designed to deliver a healthy PKP2 gene via a single intravenous dose. The company is on track to submit an Investigational New Drug application (IND) in 2023 and plans to support a global study for ARVC.
Positive
Presentation at Heart Rhythm 2022 highlights promising preclinical data for TN-401.
IND-enabling studies for TN-401 are ongoing and expected submission in 2023 creates positive outlook.
Targeting PKP2 mutations that affect over 70,000 patients indicates significant market potential.
Negative
None.
Abstract Detailing TN-401 Results in PKP2 Mouse Model Accepted for Late-Breaker Oral Presentation
TN-401 IND-Enabling Studies Ongoing, On Track to Submit IND in 2023
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease, announced that it will present new preclinical data for its TN-401 PKP2 gene therapy program at the Heart Rhythm Society’s upcoming annual Heart Rhythm 2022 meeting taking place in San Francisco, CA, and virtually. These data have been accepted for oral presentation as part of the Late-Breaking Clinical Trials: Late Breaking Science session taking place on Sunday, May 1, 2022.
TN-401 is Tenaya’s gene therapy candidate being developed for the potential treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by PKP2 gene mutations. Mutations of the PKP2 gene are the leading genetic cause of ARVC and can result in severe disease, including significant arrhythmia and sudden cardiac death in adults and children. These mutations are estimated to affect more than 70,000 patients in the U.S. alone. TN-401 is designed to use an adeno-associated viral (AAV) vector to deliver a healthy copy of the PKP2 gene to the heart muscle of affected patients via a single intravenous dose. Tenaya has initiated IND-enabling studies for TN-401, will support the establishment of a global natural history study of ARVC caused by PKP2 mutations in 2022 and expects to submit an Investigational New Drug application (IND) to the U.S. Food and Drug Administration for TN-401 in 2023.
Details of the presentation are as follows:
Sunday, May 1, 2022 9:15 a.m.-10:15 a.m. PT Late-Breaking Clinical Trials: Late Breaking Science session
Oral Presentation: Cardiac AAV:PKP2 Gene Therapy Reduces Ventricular Arrhythmias, Reverses Adverse Right Ventricular Remodeling, Improves Heart Function, and Extends Survival in a Pkp2-Deficient Mouse Model of Arrhythmogenic Right Ventricular Cardiomyopathy (Abstract 7263)
Lead author:Jane Yang, Ph.D., Senior Scientist, Tenaya Therapeutics
To view full event programming, please visit the Heart Rhythm 2022 website.
About Tenaya Therapeutics
Tenaya Therapeutics is a biotechnology company committed to a bold mission: to discover, develop and deliver curative therapies that address the underlying drivers of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and the University of Texas Southwestern Medical Center, Tenaya is developing therapies for rare genetic disorders as well as for more prevalent heart conditions through three distinct but interrelated product platforms: Gene Therapy, Cellular Regeneration and Precision Medicine. For more information, visit www.tenayatherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “will” and “plans,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, Tenaya’s plans to present preclinical data on TN-401 at Heart Rhythm 2022; Tenaya’s plan to establish a global natural history study of AVRC caused by PKP2 mutations and Tenaya’s expectations regarding the timing of the IND filing for TN-401. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the availability of data at the referenced times; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; the timing, progress and results of preclinical studies for TN-401 and Tenaya’s other programs; Tenaya’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Tenaya’s manufacturing and operations, including preclinical studies and planned clinical trials; the timing, scope and likelihood of regulatory filings and approvals; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s reliance on third parties; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
What are the results of the TN-401 gene therapy presented by Tenaya Therapeutics?
The results indicate that TN-401 reduces ventricular arrhythmias, reverses adverse right ventricular remodeling, and improves heart function in a Pkp2-deficient mouse model.
When is Tenaya Therapeutics presenting its preclinical data for TN-401?
Tenaya Therapeutics will present its preclinical data at the Heart Rhythm Society’s annual meeting on May 1, 2022.
What is the significance of the PKP2 gene mutation in ARVC?
PKP2 gene mutations are the leading genetic cause of ARVC, leading to severe arrhythmia and increasing the risk of sudden cardiac death in patients.
What are the next steps for Tenaya Therapeutics regarding TN-401?
Tenaya plans to submit an IND application for TN-401 in 2023 and establish a global natural history study of ARVC caused by PKP2 mutations.
How does TN-401 work to treat ARVC?
TN-401 utilizes an adeno-associated viral vector to deliver a healthy copy of the PKP2 gene to the heart muscle via a single intravenous dose.
