Summary: Lineage Cell Therapeutics announced promising preclinical results for ReSonance (ANP1), its auditory neuronal cell transplant designed to treat hearing loss, showcasing successful cell engraftment and survival in a preclinical model.
Takeaways:
- ReSonance (ANP1) is a novel cell therapy developed by Lineage Cell Therapeutics to restore hearing by replacing lost or dysfunctional auditory neurons, addressing the unmet need for hearing loss treatments.
- The preclinical results demonstrated successful manufacturing, cryopreservation, and engraftment of ANP1 in a hearing loss model, advancing the program toward clinical testing.
- This development builds on Lineage’s platform success, including its OpRegen cell transplant for dry AMD, and highlights their capabilities in manufacturing and advancing cell therapies for unmet medical needs.
Lineage Cell Therapeutics, a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported successful preclinical results with ReSonance (ANP1), the company’s auditory neuronal cell transplant for the treatment of hearing loss.
The results were presented at the 59th Annual Inner Ear Biology Workshop by Ofer Wiser, PhD, 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,” says 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.”
Cell-Based Therapy for Hearing Loss
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.
Further reading: Lineage Cell Therapeutics Announces Auditory Neuronal Cell Transplant
Preclinical Testing of ReSonance (ANP1)
Preclinical testing of ANP1 is ongoing through a collaboration with the University of Michigan and Yehoash Raphael, PhD, 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, according to Lineage Cell Therapeutics.
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.
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