March 21, 2022 8:00 AM EDT |
Lineage Announces Pipeline Expansion to Include Auditory Neuronal Cell Therapy for Treatment of Hearing Loss |
- Expansion of Pipeline Into a Third Neuronal Cell Type Builds on Existing Capabilities
- Intellectual Property Has Been Filed Covering Composition and Methods for Generating Auditory Neuronal Progenitors
- Hearing Loss Afflicts More Than 5% of the Population; More Than 430 Million People
CARLSBAD, Calif.--(BUSINESS WIRE)--Mar. 21, 2022-- Lineage Cell Therapeutics, Inc.
(NYSE American and TASE: LCTX), a clinical-stage biotechnology company
developing allogeneic cell therapies for unmet medical needs, today
announced that the Company is expanding its novel cell therapy pipeline
to include a new investigational product candidate, an auditory neuronal
cell transplant for the treatment of hearing loss, with an initial
focus on the treatment of auditory neuropathy spectrum disorders. To
support this new therapeutic effort, Lineage has filed for intellectual
property covering the composition and methods for generating auditory
neuronal progenitors which may be capable of functioning as
sensory neurons and the connecting neuronal ganglion cells of the ear,
and to methods of treatment that employ these cells for the potential
treatment of auditory neuropathy. According to the World Health
Organization, hearing loss currently afflicts over 5% of the world’s
population, or more than 430 million people, and by 2050 it is estimated
that one in every ten people, or more than 700 million people, will
have disabling hearing loss.
“Hearing loss is a major sensory
deficit which affects an enormous number of individuals worldwide, yet
current approaches leave much room for improvement. I am pleased to be
advising Lineage and providing insights and experience in the launch of
this new endeavor and working toward developing cell-based solutions for
this condition,” stated Stefan Heller, Ph.D.,
Edward C. and Amy H. Sewall Professor, Stanford University School of
Medicine, Department of Otolaryngology – Head & Neck Surgery and
Institute for Stem Cell Biology and Regenerative Medicine ISCBRM.
“We
are excited to announce this new, internally-developed initiative for
Lineage, and to do it so quickly following the partnership we announced
with Roche and Genentech for our lead program, OpRegen®, in a
deal worth up to $670M USD,” added Brian Culley, Lineage CEO. “Many
patients with sensorineural hearing loss are poorly addressed, cannot
benefit from cochlear implants, and/or have no FDA-approved treatment
options. Similar to OpRegen, which has demonstrated to be able to
replace and restore retinal pigment epithelium cells in patients with
vision loss, and OPC1, which similarly replaces oligodendrocytes for the
treatment of spinal cord injury, replacing auditory neurons or
augmenting an existing but damaged auditory neuron population may
provide a benefit beyond the reach of alternate approaches such as
prostheses. We believe auditory neuronal transplants represent a unique
opportunity to leverage our knowhow and capabilities in cellular
differentiation into a fourth indication with a large unmet need. In
addition to the speed with which the team created this new program from
our internal technology, we have done so with a modest investment of
capital so far, because we were able to take advantage of our
established manufacturing infrastructure and broad knowhow in the
expansion and differentiation of pluripotent cells. This is another
example of the efficiency and versatility of our technology platform,
which is gaining broader awareness, and which offers us a favorable
competitive position in the emerging fields of regenerative medicine and
anti-aging technologies.”
Auditory neuropathy is a hearing
disorder in which the inner ear successfully detects sound but has a
problem with sending signals from the ear to the brain. 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. Outer hair cells help amplify sound vibrations entering the
inner ear from the middle ear. When hearing is working normally, the
inner hair cells convert these vibrations into electrical signals that
travel as nerve impulses to the brain, where the brain interprets the
impulses as sound. Auditory neuropathy can be caused by a number of
factors including: (i) damage to the auditory neurons that transmit
sound information from the inner hair cells – specialized sensory cells
in the inner ear – to the brain; (ii) damage to the inner hair cells
themselves; (iii) inherited genes with mutations or suffering damage to
the auditory system, either of which may result in faulty connections
between the inner hair cells and the auditory nerve, which leads from
the inner ear to the brain; or (iv) damage to the auditory nerve itself.
Researchers are still seeking effective treatments for those affected
with auditory neuropathy.