Lineage Presents Preclinical Data on Its Auditory Neuronal Cell Transplant Program, ReSonance™, at the 59th Annual Inner Ear Biology Workshop
18 9월 2024 - 9:00PM
Business Wire
- ReSonance is Manufactured by a Proprietary Process,
Developed In-House, at Clinical Scale, with Relevant In-Vitro
Functional Activity
- Immediate-Use, Thaw-and-Inject Formulation Durably Engrafted
in Multiple Preclinical Hearing Loss Models
- ReSonance is Currently Being Evaluated in a Functional Model
of Hearing Loss
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, today reported that preclinical
results with ReSonance (ANP1), the Company’s auditory neuronal cell
transplant for the treatment of hearing loss, were presented at the
59th Annual Inner Ear Biology Workshop by Ofer Wiser, Ph.D. Senior
Scientist, Technological Innovation at Cell Cure Neurosciences,
Inc., the Company’s Israel-based subsidiary, which is responsible
for research, process development, and good manufacturing practice
(GMP) production.
“We are excited to report on the continued successful
pre-clinical development of ReSonance, our first
internally-developed cell transplant program, which we believe
illustrates the efficiency and breadth of our technology platform,”
stated Brian Culley, Lineage CEO. “Building on the success of our
OpRegen® RPE cell transplant candidate for dry AMD, our process
development team generated new methods of differentiation which
enabled us to create a new product candidate for hearing loss. We
advanced from a product concept through the successful manufacture
of the desired and specific cell type, generating new intellectual
property, and thereafter advancing ANP1 into initial preclinical
testing. An inherent aspect of our successful manufacturing efforts
was the generation of a cryopreserved, ready to administer
thaw-and-inject formulation at a clinically testable dose, which
demonstrated successful engraftment and survival in a preclinical
hearing loss model. Given the many challenges of reliably and
affordably manufacturing cell and gene therapy product candidates,
we are excited to highlight the progress Lineage has made in this
area and believe our unique manufacturing capabilities will
continue to provide us with a leading position in the cell
transplant space.”
Hearing loss is a significant unmet medical need and by 2050,
nearly 2.5 billion people are estimated to be impacted by listening
impairments across the globe. The loss of auditory nerve cells can
lead to auditory neuropathy, even when hair cells and the cochlear
nucleus remain intact. A cell-based therapy designed to replace
lost or dysfunctional auditory neurons may restore hearing and
enhance the degree of success of a cochlear implant procedure by
repopulating the cochlea with transplanted, functional auditory
neurons.
Preclinical testing of ANP1 is ongoing through a collaboration
with the University of Michigan and Yehoash Raphael, Ph.D., The R.
Jamison and Betty Williams Professor of Otolaryngology, Department
of Otolaryngology-Head and Neck Surgery and Lab Director at the
University of Michigan Kresge Hearing Research Institute.
Auditory neuropathy is a challenging hearing disorder in which
the inner ear successfully detects sound but has a problem with
sending signals from the ear to the brain, currently accounting for
approximately 10% of cases of sensorineural hearing loss (SNHL) in
children. Current state of the art medical knowledge suggests that
auditory neuropathies play a substantial role in hearing
impairments and deafness. Hearing depends on a series of complex
steps that change sound waves in the air into electrical signals.
The auditory nerve then carries these signals to the brain.
Auditory neuropathy can be caused by a number of factors including
damage to the auditory neurons or loss of these neurons.
Researchers are still seeking effective treatments for those
affected with auditory neuropathy.
The 59th Annual Inner Ear Biology Workshop presentation is now
available on the Events and Presentations section of Lineage’s
website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel, “off-the-shelf,” cell therapies to
address unmet medical needs. Lineage’s programs are based on its
proprietary cell-based technology platform and associated
development and manufacturing capabilities. From this platform,
Lineage designs, develops, manufactures, and tests specialized
human cells with anatomical and physiological functions similar or
identical to cells found naturally in the human body. These cells
are created by applying directed differentiation protocols to
established, well-characterized, and self-renewing pluripotent cell
lines. These protocols generate cells with characteristics
associated with specific and desired developmental lineages. Cells
derived from such lineages are transplanted into patients in an
effort to replace or support cells that are absent or dysfunctional
due to degenerative disease, aging, or traumatic injury, and to
restore or augment the patient’s functional activity. Lineage’s
neuroscience focused pipeline currently includes: (i) OpRegen, a
retinal pigment epithelial cell therapy in Phase 2a development
under a worldwide collaboration with Roche and Genentech, a member
of the Roche Group, for the treatment of geographic atrophy
secondary to age-related macular degeneration; (ii) OPC1, an
oligodendrocyte progenitor cell therapy in Phase 1/2a development
for the treatment of spinal cord injuries; (iii) ReSonance (ANP1),
an auditory neuronal progenitor cell therapy for the potential
treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural
cell therapy for the potential treatment of vision loss due to
photoreceptor dysfunction or damage; and (v) RND1, a novel
hypoimmune induced pluripotent stem cell line being developed in
collaboration with Eterna Therapeutics Inc. For more information,
please visit www.lineagecell.com or follow the company on X/Twitter
@LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “aim,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “design,” “intend,”
“expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,”
“should,” “would,” “contemplate,” “project,” “target,” “tend to,”
or the negative version of these words and similar expressions.
Lineage’s forward-looking statements are based upon its current
expectations and beliefs and involve assumptions that may never
materialize or may prove to be incorrect. Such statements include,
but are not limited to, statements relating to: the potential use
of ANP1 to restore hearing or enhance the degree of success of a
cochlear implant procedure; the broad potential for Lineage’s
regenerative medicine platform and Lineage’s ability to advance and
expand the same, including Lineage’s ability to manufacture new
specific and differentiated cell types on anticipated timelines and
budgets; the potential for Lineage’s investigational allogeneic
cell therapies to generate clinical outcomes beyond the reach of
traditional methods, including gene therapy, and provide safe and
effective treatment for multiple, diverse serious or life
threatening conditions; and the potential of our platform
technology and/or manufacturing capabilities to create success in
the cell transplant space. Forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause
Lineage’s actual results, performance or achievements to be
materially different from future results, performance or
achievements expressed or implied by the forward-looking statements
in this press release, including, but not limited to, the following
risks: that positive findings in early clinical and/or nonclinical
studies of a product candidate may not be predictive of success in
subsequent clinical and/or nonclinical studies of that candidate;
that OpRegen may never be proven to provide durable anatomical
functional improvements in dry-AMD patients, that the ongoing
Israel-Hamas war may materially and adversely impact our
manufacturing processes, including cell banking and product
manufacturing for our cell therapy product candidates, all of which
are conducted by our subsidiary in Jerusalem, Israel; that Lineage
may not be able to manufacture sufficient clinical quantities of
its product candidates in accordance with current good
manufacturing practice; and those risks and uncertainties inherent
in Lineage’s business and other risks discussed in Lineage’s
filings with the Securities and Exchange Commission (SEC). Further
information regarding these and other risks is included under the
heading “Risk Factors” in Lineage’s periodic reports with the SEC,
including Lineage’s most recent Annual Report on Form 10-K filed
with the SEC and its other reports, which are available from the
SEC’s website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Lineage undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law. All forward-looking statements are expressly qualified in
their entirety by these cautionary statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240918699918/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Russo Partners – Media Relations Nic Johnson or David
Schull (Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com) (212) 845-4242
Lineage Cell Therapeutics (AMEX:LCTX)
과거 데이터 주식 차트
부터 9월(9) 2024 으로 10월(10) 2024
Lineage Cell Therapeutics (AMEX:LCTX)
과거 데이터 주식 차트
부터 10월(10) 2023 으로 10월(10) 2024