Tenaya Therapeutics to Present Preclinical Data on TN-401 PKP2 Gene Therapy Program at Heart Rhythm 2022
28 April 2022 - 10:00PM
Business Wire
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
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.
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Investors Michelle Corral Tenaya Therapeutics
IR@tenayathera.com Media Wendy Ryan Ten Bridge
Communications wendy@tenbridgecommunications.com
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