CARLSBAD, CALIFORNIA — Lineage Cell Therapeutics announced that its experimental ReSonance (ANP1) cell therapy program for hearing loss has completed the development activities planned for the first year of its research collaboration with William Demant Invest (WDI), allowing the project to advance into its second year.
The program is exploring whether transplanted auditory nerve cells could eventually improve hearing outcomes for certain individuals with severe-to-profound sensorineural hearing loss, particularly cochlear implant recipients whose limited benefit may be associated with auditory nerve degeneration.
Lineage reported several development milestones, including the production of its first batch of cells manufactured under current Good Manufacturing Practice (cGMP) standards, progress in preclinical testing, and preparations for discussions with Danish regulators.
ReSonance remains an investigational therapy in preclinical development and has not yet been evaluated in human clinical trials.
Progress in Cell Manufacturing and Preclinical Research
ReSonance is an auditory neuronal progenitor cell therapy being developed using Lineage’s AlloSCOPE manufacturing platform. The approach involves producing specialized cells that could potentially replace or support damaged auditory neurons within the cochlea.
The project is being developed through a three-year research collaboration between Lineage and William Demant Invest, established in August 2025 and supported by up to $12 million in research funding.
The collaboration brings together Lineage’s cell therapy manufacturing capabilities and the hearing research expertise of Eriksholm Research Centre, which is part of Oticon and the Demant Group.
According to Lineage, the first year of work included the successful manufacturing of an initial cGMP-grade batch of material, three additional engineering manufacturing runs, and the transfer of manufacturing processes from its research team to its clinical-grade manufacturing team.
Researchers have also established a preclinical model of deafening intended to support future functional testing of ReSonance. The collaboration’s Joint Scientific Committee has approved moving into the second year of development.
Lineage CEO Brian Culley said the progress reflects the company’s ability to advance its cell therapy technology toward potential clinical applications.
“We have now completed all contemplated development activities planned in the first year of our collaboration, including demonstrating our manufacturing expertise by successfully completing the first batch of cGMP grade material, in addition to three engineering batches; completing the internal technology transfer from our R&D team to our cGMP team; and working with our partners at Eriksholm Research Center and academic collaborators on establishing a preclinical model of deafening to support ReSonance functional preclinical testing and in support of the planned meeting with the Danish Medicines Agency later this quarter to review development plans for this exciting product candidate.”
Could Cell Therapy Improve Cochlear Implant Outcomes?
Unlike conventional hearing aids or cochlear implants, ReSonance is being investigated as a way to address damage to the auditory neurons themselves.
These neurons, known as spiral ganglion neurons, play an essential role in transmitting auditory information from the cochlea to the brain. Although cochlear implants bypass damaged sensory hair cells through electrical stimulation, their effectiveness still depends on the auditory nerve’s ability to transmit those signals.
For some individuals, damage or loss of these neurons may contribute to limited speech understanding despite otherwise successful cochlear implantation.
Lineage’s proposed approach involves transplanting auditory neuronal progenitor cells into the cochlea, with the goal of establishing or improving the neural connections needed to transmit auditory information.
However, identifying which patients might benefit remains a significant challenge. Poor cochlear implant outcomes can result from many factors beyond auditory nerve damage, including electrode placement, programming, duration of deafness, and central auditory or cognitive factors.
A recent review published in Hearing Research examined how auditory nerve cell therapy might be evaluated in future cochlear implant patients, including the diagnostic approaches, patient selection criteria, and surgical techniques that would need to be considered.
The review, developed by researchers affiliated with Eriksholm Research Centre and several academic and clinical institutions, emphasizes that limited cochlear implant performance alone is not sufficient evidence of auditory nerve degeneration.
Researchers would need to establish that nerve dysfunction is a major contributor to an individual’s hearing difficulties before determining whether experimental neuronal replacement therapy could be appropriate.
Regulatory Discussions Planned for Late 2026
Lineage and its collaborators are preparing for a meeting with the Danish Medicines Agency during the fourth quarter of 2026 to discuss the ReSonance development program and seek scientific advice on potential next steps.
The collaboration’s ongoing work includes additional laboratory and preclinical testing, further characterization of the transplanted cells, and continued development of methods for delivering the therapy into the cochlea.
These activities are intended to support a potential future application to begin human clinical testing, although Lineage has not announced a date for the start of a ReSonance clinical trial.
Beyond demonstrating that the cells can be manufactured consistently, researchers will need to establish whether they can survive after transplantation, develop the necessary connections with the auditory pathway, function appropriately, and remain safe over time.
The company expects additional preclinical findings to be presented at scientific and medical conferences during 2027.
For hearing healthcare professionals, the ReSonance program represents a different investigational approach from gene therapies designed to address specific genetic causes of hearing loss. Rather than targeting an individual gene, the cell therapy strategy aims to replace or support damaged auditory neurons that may be affected by several underlying conditions.
Whether this approach can produce meaningful improvements in hearing or cochlear implant performance will depend on future preclinical findings and, ultimately, controlled human clinical studies.
About Lineage Cell Therapeutics
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic, or “off-the-shelf,” cell therapies for serious medical conditions. Its programs use the company’s proprietary AlloSCOPE platform to manufacture specialized human cells intended to replace or support cells that are damaged or dysfunctional. Its development pipeline includes investigational treatments for retinal disease, spinal cord injury, and hearing loss.
Source: Lineage Cell Therapeutics
