Tenaya Therapeutics Provides 2022 Business Updates
January 10 2022 - 8:00AM
Business Wire
- Company announces development candidate selection of its second
gene therapy program, TN-401, targeting the leading genetic cause
of arrhythmogenic right ventricular cardiomyopathy (gARVC)
- IND applications for TN-201 and TN-301 (previously named
TYA-11631) expected to be submitted in the second half of 2022
- Appoints Jennifer Drimmer, J.D., as General Counsel
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, today provided
a 2022 business update including the selection of TN-401 as the
development candidate for the treatment of Genetic Arrhythmogenic
Right Ventricular Cardiomyopathy (gARVC) due to PKP2 gene mutation.
In addition, Tenaya appointed Jennifer Drimmer, J.D., as its
General Counsel.
“After an exciting year in 2021, Tenaya is off to a strong start
in 2022 with the selection of TN-401 as a development candidate
that provides new hope to patients and families fighting gARVC,”
said Faraz Ali, Chief Executive Officer of Tenaya. “With three
therapeutic candidates now advancing toward the clinic, we look
forward to another year of important milestones and operational and
scientific progress. We also continue to strengthen the leadership
team with the appointment of Jennifer who adds highly relevant
experience, depth, and diversity. We have never been better
positioned to deliver on our mission to fundamentally change the
paradigm of treatment for both rare and prevalent forms of heart
disease.”
Business and Program Updates
- TN-401 - PKP2 Gene Therapy Program for Genetic
Arrhythmogenic Right Ventricular Cardiomyopathy (gARVC):
- Tenaya has nominated TN-401 as a clinical drug candidate to
treat patients carrying PKP2 gene mutations. Mutations of the PKP2
gene are the leading genetic cause of ARVC and can cause 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 US alone. Based on publicly
available information to date, we believe there are no approved
disease-specific therapies.
- Tenaya expects to present new preclinical data supporting the
TN-401 program including dose-dependent efficacy, survival
durability, and mechanistic insights at a scientific conference in
2022.
- Tenaya has successfully scaled up production of TN-401 to 200L
and is initiating IND enabling studies. Tenaya will also support
establishment of a global natural history study in 2022 and expects
to submit an IND in 2023.
- TN-201 – MYBPC3 Gene Therapy Program for Genetic
Hypertrophic Cardiomyopathy (gHCM):
- Tenaya has previously announced initiation of IND-enabling
activities and expects to submit an IND to the FDA in the second
half of 2022.
- The safety and efficacy of TN-201 will initially be explored in
symptomatic adult patients with MYBPC3 mutations and the
non-obstructive form of HCM (nHCM). Approximately 70% of patients
with truncating MYBPC3 mutations have the nHCM form of the disease
where surgical myectomy is not an option and the unmet need is
high.
- Tenaya continues site activation and patient enrollment in the
MyClimb global natural history study to support and potentially
expedite the future evaluation of TN-201 in pediatric patients
during clinical development after early safety has been established
in adults.
- TN-201 has been granted orphan drug designation by the
FDA.
- TN-301 – HDAC6 Inhibitor (Small Molecule for Heart Failure
with Preserved Ejection Fraction):
- Tenaya has continued to generate strong preclinical data
supporting the multi-modal mechanism of action of TN-301 in
multiple disease models and expects to present these at a
scientific conference in 2022.
- Tenaya has previously announced initiation of IND-enabling
activities and a cGMP manufacturing campaign and expects to submit
an IND to the FDA in the second half of 2022.
- The safety, tolerability, pharmacokinetics, and
pharmacodynamics of TN-301 will initially be assessed in healthy
volunteers, as well as possibly in pre-diabetic participants to
assess target engagement and proof of activity.
- Manufacturing:
- Tenaya expects its state-of-the-art, modular cGMP manufacturing
facility in Union City, California will become operational in the
first half of 2022, and will support the production of drug product
at multiple scales for clinical studies for all AAV-based programs,
including TN-201 and TN-401.
- Leadership Team:
- Tenaya continues to strengthen its leadership team with the
appointment of Jennifer Drimmer, J.D., as its General Counsel.
Jennifer has more than 17 years of experience including public
company expertise and executive leadership in corporate governance,
contracting, mergers and acquisitions, and legal operations. She
previously served as Senior Vice President of Corporate Legal
Affairs and Secretary at Exelixis, Inc. (NASDAQ: EXEL) responsible
for leading the corporate governance and public company reporting
functions. Ms. Drimmer received her B.A. from the University of
California, San Diego, and her J.D. from the University of
California, Davis School of Law.
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 “expects” and “will,” and
similar expressions are intended to identify forward-looking
statements. Such forward-looking statements include, among other
things, statements regarding the expected timing of IND
applications for TN-201, TN-301 and TN-401, statements regarding
the potential of and expectations regarding Tenaya’s product
candidates and programs, including TN-201, TN-301 and TN-401,
statements regarding the cGMP manufacturing facility, expectations
with respect to various scientific conferences, the sufficiency of
projected cash flows, and statements by Tenaya’s chief executive
officer. 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: 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-201, TN-301, 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 Leone Patterson Tenaya Therapeutics
IR@tenayathera.com
Media Wendy Ryan Ten Bridge Communications
Wendy@tenbridgecommunications.com
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