Taysha Gene Therapies Provides Update on Deprioritized Pipeline Programs
15 Février 2024 - 10:01PM
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or “the
Company”), a clinical-stage gene therapy company focused on
developing and commercializing AAV-based gene therapies for the
treatment of monogenic diseases of the central nervous system
(CNS), today provided an update on its deprioritized pipeline
programs as part of an ongoing effort to help support their further
potential development.
Taysha has been working to find ways to advance its
deprioritized programs. On November 13, 2023, Taysha terminated its
existing loan and security agreement and entered into a new loan
and security agreement that provides consent to allow the Company
to transfer intellectual property (IP) for several deprioritized
programs to third parties in a more efficient manner. The Company’s
new loan and security agreement also extended its cash runway into
2026.
Recent progress on previously deprioritized pipeline programs
includes:
- TSHA-120: The Company initiated the transfer of the United
States Food and Drug Administration Investigational New Drug (IND)
application and investigational clinical trial material for
TSHA-120 in giant axonal neuropathy (GAN) to clinical trial
collaborator National Institute of Neurological Disorders and
Stroke (NINDS), creating an opportunity for continued clinical
evaluation of TSHA-120 in GAN. Additionally, the Company entered
discussions with the originating advocacy organization regarding
TSHA-120 in an effort to transfer rights back to the advocacy
organization to move the program forward.
- TSHA-101: The Company transferred rights back to Queen’s
University (Queen’s) for TSHA-101 in GM2 gangliosidosis, resulting
in Queen’s regaining exclusive IP to the program.
- TSHA-104 and TSHA-112: The Company transferred rights back to
the originating institution for select programs, including TSHA-104
in SURF1-associated Leigh syndrome and TSHA-112 in APBD.
- TSHA-118: The Company provided investigational clinical trial
material for TSHA-118 in CLN1 to support an individual-patient
investigator-initiated IND request from RUSH University Medical
Center for the treatment of a patient with CLN1 disease.
“Today’s announcement demonstrates meaningful progress to
advance important development work for several deprioritized
programs. Creating options for these programs has been a focus
since the Company completed a management change in December 2022,
and the new loan and security agreement afforded the flexibility to
implement certain opportunities,” said Sean P. Nolan, Chairman and
Chief Executive Officer of Taysha. “As we continue to focus on
advancing our lead TSHA-102 program for the treatment of Rett
syndrome, we are pleased that we can ensure these programs are
provided to the right advocates, clinicians and scientific experts
who can potentially move these programs forward for the benefit of
patients.”
The Company continues to explore potential partnerships and
opportunities for its other deprioritized programs to help support
their further potential development.
About Taysha Gene Therapies Taysha Gene
Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company
focused on advancing adeno-associated virus (AAV)-based gene
therapies for severe monogenic diseases of the central nervous
system. Its lead clinical program TSHA-102 is in development for
Rett syndrome, a rare neurodevelopmental disorder with no approved
disease-modifying therapies that address the genetic root cause of
the disease. With a singular focus on developing
transformative medicines, Taysha aims to address severe unmet
medical needs and dramatically improve the lives of patients and
their caregivers. The Company’s management team has proven
experience in gene therapy development and commercialization.
Taysha leverages this experience, its manufacturing process and a
clinically and commercially proven AAV9 capsid in an effort to
rapidly translate treatments from bench to bedside. For more
information, please visit www.tayshagtx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“anticipates,” “believes,” “expects,” “intends,” “projects,”
“plans,” and “future” or similar expressions are intended to
identify forward-looking statements. Forward-looking statements
include statements concerning Taysha’s cash runway and potential
partnerships and opportunities for Taysha’s deprioritized programs.
Forward-looking statements are based on management’s current
expectations and are subject to various risks and uncertainties
that could cause actual results to differ materially and adversely
from those expressed or implied by such forward-looking statements.
Accordingly, these forward-looking statements do not constitute
guarantees of future performance, and you are cautioned not to
place undue reliance on these forward-looking statements. Risks
regarding our business are described in detail in
our Securities and Exchange Commission (“SEC”) filings,
including in our Annual Report on Form 10-K for the full-year
ended December 31, 2022, and our Quarterly Report on Form 10-Q
for the quarter ended September 30, 2023, both of which are
available on the SEC’s website at www.sec.gov. Additional
information will be made available in other filings that we make
from time to time with the SEC. These forward-looking
statements speak only as of the date hereof, and we disclaim any
obligation to update these statements except as may be required by
law.
Company Contact:Hayleigh CollinsDirector, Head
of Corporate Communications and Investor RelationsTaysha Gene
Therapies, Inc.hcollins@tayshagtx.com
Media Contact:Carolyn HawleyInizio
EvokeCarolyn.hawley@inizioevoke.com
Taysha Gene Therapies (NASDAQ:TSHA)
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