Tenaya Therapeutics Publishes Preclinical Data in Circulation Highlighting the Clinical Potential of Cellular Reprogramming for Cardiac Regeneration
02 Ottobre 2023 - 11:30PM
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 the publication of
preclinical research in the October 3, 2023 issue of the American
Heart Association’s (AHA) journal, Circulation. The article, titled
“Improved Cardiac Function in Postischemic Rats Using an Optimized
Cardiac Reprogramming Cocktail Delivered in a Single Novel
Adeno-Associated Virus,” details Tenaya’s initial success in
cardiac cellular regeneration utilizing a single adeno-associated
viral (AAV) vector to deliver specific combinations of genes to
reprogram cells in the heart following ischemic injury.
“In an effort to restore contraction to a heart weakened by
myocardial infarction, we’ve developed an elegant approach to
reprogram select cardiac cells that combines specific genes and
regulatory elements into a single adeno-associated vector. Using
this approach in a model of chronic ischemic injury we successfully
achieved – for the first time – dose-dependent and durable
improvements in heart function through cardiac regeneration,” said
Tim Hoey, Ph.D., Chief Scientific Officer of Tenaya. “Significant
molecular engineering challenges needed to be overcome to make
cardiac cellular regeneration feasible for therapeutic development
and this work represents a major step forward in advancing the
potential application of our cellular reprogramming approach in a
clinical setting.”
An estimated four million people in the U.S. are living with
heart failure associated with a prior heart attack, or myocardial
infarction (MI). When an MI occurs, cardiomyocytes (CMs), the heart
cells responsible for contraction, are lost, while cardiac
fibroblasts (CFs), the heart cells that form connective tissue,
multiply and contribute to the formation of scar tissue and
fibrosis. The loss of CMs following MI permanently impairs heart
contraction, leading to heart failure and potentially fatal
arrhythmias, and is estimated to result in the death of
approximately 5% to 10% of heart attack survivors within the first
year. There are currently no approved treatments that address the
underlying loss of heart tissue.
Tenaya researchers achieved several breakthroughs in their
effort to create a cellular reprogramming product candidate with
potential clinical and commercial viability:
- Tenaya identified and selected a proprietary combination of
three genes to drive the efficient conversion of CFs into CMs that
is small enough to be delivered in a single AAV vector.
- Tenaya researchers engineered a novel AAV capable of targeting
CFs with increased infectivity compared to parental AAV
serotypes.
- Tenaya researchers incorporated regulatory elements to focus
robust expression in CFs and to de-target expression of this
combination of genes in both preexisting and newly created
CMs.
As detailed in the Circulation article, this novel AAV
reprogramming construct, when injected into the hearts of acute
mouse MI and chronic rat MI models, achieved significant and
dose-dependent improvement in cardiac functions. This effect was
sustained out to 29 weeks in the chronic rat MI model. This is the
first time such a result has been achieved in a chronic model of MI
after formation of a permanent scar. To further validate the
efficacy of Tenaya’s reprogramming AAV construct, a series of
controls in the in vivo studies were performed that supported new
CM formation as the underlying mechanism for functional
improvement.
“Tenaya was founded with the aim of tackling some of the
toughest challenges contributing to heart disease, the leading
cause of death in the world,” said Faraz Ali, Tenaya’s Chief
Executive Officer. “Our ongoing preclinical efforts to advance
cardiac cellular reprogramming exemplifies the differentiated
capabilities of our Research team and demonstrates our commitment
to pursuing innovative and modality-agnostic drug discovery
alongside our pipeline of more advanced, clinical-stage product
candidates.”
This program is currently at the candidate selection stage.
Tenaya is continuing its cardiac reprogramming research in
preclinical studies of large animals using Tenaya’s proprietary
injection catheter with support from grant funding from the
California Institute for Regenerative Medicine (CIRM).
About Tenaya’s Cellular Reprogramming
ResearchTenaya is developing an AAV-based approach to
cellular regeneration that involves converting (or reprogramming)
existing cardiac fibroblasts within the heart into new
cardiomyocytes in order to replace cells permanently lost due to
heart attack, or myocardial infarction. These efforts build on
foundational work by Tenaya co-founder, Deepak Srivastava, M.D.,
President of the Gladstone Institute of Cardiovascular Disease and
Tenaya Board member and Chair of Tenaya Scientific Advisory Board.
Prior Tenaya presentations have consistently demonstrated promising
results of this approach in multiple disease models, including
primary human CFs, mice, rats, and most importantly in pigs with
human-sized hearts. As part of the company’s efforts, Tenaya also
has developed a novel intra-endomyocardial injection catheter for
more precise delivery of therapeutic payloads to the location of MI
injury in human subjects during clinical studies.
About Tenaya TherapeuticsTenaya 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.
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 “potential,”
“commitment,” and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements
include, among other things, the clinical and commercial potential
of Tenaya’s cellular reprogramming approach and Tenaya’s commitment
to pursuing innovative and modality-agnostic drug discovery
alongside the company’s clinical-stage product candidates. 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 potential for any clinical trial results to differ from
preclinical, interim, preliminary, topline or expected results;
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; Tenaya’s ability to raise any additional funding it
will need to continue to pursue its business and product
development plans; Tenaya’s reliance on third parties; Tenaya’s
ability to successfully operate a manufacturing facility for
clinical or commercial supply; Tenaya’s commercialization and
marketing capabilities and strategy; the loss of key scientific or
management personnel; competition in the industry in which Tenaya
operates; 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.
Contacts
ContactMichelle CorralVP, Corporate
Communications and Investor RelationsIR@tenayathera.com
InvestorsJulie SeidelStern Investor
RelationsJulie.seidel@SternIR.com
MediaWendy RyanTen Bridge
Communicationswendy@tenbridgecommunications.com
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