Dec 2017 Genetic Engineering & Biotechnology News

Frequency Therapeutics successfully completed a first-in-human study evaluating its lead Progenitor Cell Activation (PCA) candidate FX-322, which is in development to restore hearing in patients with hearing loss due to loss of inner ear hair cells. FX-322 is a proprietary combination of small molecules that are designed to activate inner ear progenitor cells and the generation of new inner ear hair cells in the cochlea. The completed Phase I study, carried out at the Royal Victoria Eye and Ear Hospital in Melbourne, Australia, enrolled nine adult patients with severe to profound sensorineural hearing loss who were scheduled to receive a cochlear implant within 24 hours after intratympanic injection of FX-322. 

New hair cells
The trial, which met all its endpoints, was designed to demonstrate the safety and tolerability of FX-322. “This goal was achieved by showing that FX-322 was well tolerated with no drug-related adverse events reported,” commented lead study investigator Stephen O’Leary, Ph.D., who is the William Gibson Chair of Otolaryngology at the University of Melbourne. “Further, the results validated the feasibility of using a standard intratympanic injection to deliver FX-322 locally to the inner ear. In addition, we found that FX-322 successfully diffused from the middle ear to the perilymph fluid in the cochlea with minimal systemic drug exposure.”

Newly-formed cochlear hair cells from The Hearing Review Feb 2017

Frequency says the completed first-in-human trial lays a foundation for future studies in patients with moderate hearing loss, who aren’t eligible for cochlea implants, and whose hearing can be followed over time following treatment with FX-322. “Our Phase I study provides crucial data on safety and pharmacokinetics associated with intratympanic delivery of FX-322 as we move forward to clinical trials to monitor efficacy,” added Daniel J. Lee, M.D., chair of the Clinical Advisory Board of Frequency and associate professor, department of otolaryngology, Massachusetts Eye and Ear and Harvard Medical School. “FX-322 represents a new class of targeted small-molecule therapies in Frequency’s PCA portfolio with the potential to transform the field of regenerative medicine.”
Founded in 2015, Frequency is developing small-molecule drugs that transiently activate Lgr5+ progenitor cells to differentiate and regenerate damaged tissues. Unlike other approaches, Frequency’s technology is designed to activate stemness and trigger progenitor cell differentiation, rather than force conversion of Lgr5+ cells into the desired cell type. Potential applications include hearing loss, skin disorders, and gastrointestinal disease, the firm claims. Frequency raised $32 million in Series A funding earlier this year to support development of its hearing restoration program.

Dec 2017 BusinessWire

Advanced Bionics announced that they will incorporate Sonova’s revolutionary SWORD™ (Sonova Wireless One Radio Digital) chip and wireless radio technology into their portfolio of solutions. Current users of the Naída CI Q90 sound processor, and future recipients, will be able to connect to any Bluetooth-enabled cell phone. The low-voltage wireless chip has the lowest power consumption of any Bluetooth Classic device used in hearing instruments and works seamlessly with Sonova proprietary 2.4 GHz wireless protocols, including Roger.

Sonova brand users (Phonak, Unitron, Hansaton, and Advanced Bionics) are free to select their cell phone technology based on their personal preferences, and not the compatibility of their hearing instrument. SWORD low-voltage radio chip runs multiple communication protocols: Standard Bluetooth to connect to multimedia audio sources, proprietary protocols such as AirStream for excellent sound quality for TV streaming, and the ear-to-ear communication protocols supporting binaural applications. SWORD technology addresses the Android operating system while also providing compatibility with Apple’s iPhone.

Dec 2017 Australian Hearing Hub

Macquarie University and Cochlear announced the establishment of the co-funded Cochlear Chair in Hearing and Healthy Ageing at Macquarie University, a role that will strengthen and formalise the strategic collaboration between the organisations. Cochlear has long supported clinically-focused hearing research, audiology education and advocacy in hearing health care. The Cochlear Chair at Macquarie University will align this focus with the University’s own commitments in hearing research and education, as well as clinical practice and advocacy. The Chair will oversee the implementation of collaborative research and education strategies, with the long-term goal of developing a leading platform for further impactful research in hearing in Australia.

Professor S. Bruce DowtonMacquarie’s Vice-Chancellor Professor S. Bruce Dowton (left) and Cochlear’s President Dig Howitt (right)

The announcement was made at Cochlear headquarters by Macquarie’s Vice-Chancellor Professor S Bruce Dowton, together with Cochlear’s President Dig Howitt, who was recently announced as Cochlear’s next Chief Executive Officer. “Around 3.6 million Australians are affected by hearing loss, a number that will double by 2060 as the population ages. Macquarie University and Cochlear continue to commit ourselves to addressing that major health priority,” said Professor Dowton.

“Macquarie is home to the Australian Hearing Hub, and Cochlear continues to lead the market with innovative new hearing technologies — together we exemplify the strategic industry-academic engagement called for in the Australian Government’s National Innovation and Science Agenda, and we are in a good position for further impactful research in the hearing space.”
In addition to its commitment to the Cochlear Chair, Cochlear has also committed to provide financial support for the ongoing research activities of the University’s Professor of Hearing, Language & The Brain and Australian Laureate Fellow, Professor David McAlpine.

“Hearing loss is a major public health problem. There is increasing evidence of the importance of hearing to overall health, especially as people age. Developing evidence of the impact of untreated hearing loss on people’s health and the economy, and the effectiveness of treatments, is critical to ensuring hearing loss is treated appropriately. We are proud to sponsor the Cochlear Chair in Hearing and Healthy Ageing at Macquarie and to provide support to Professor McAlpine’s research. Professor McAlpine has already made significant contributions to the fields of audiology and hearing,” said Dig Howitt.

Cochlear moved its purpose-built global headquarters to Macquarie University’s North Ryde campus in 2010, allowing a strategic collaboration to grow in support of research, learning and teaching and advocacy around hearing health. This partnership has only increased in strength and benefit to the hearing health community, particularly with Macquarie’s establishment of the Australian Hearing Hub in 2013, which brings together a variety of research centres and hearing stakeholders.

Dec 2017 Australian Hearing Hub

Dr Brent Edwards

National Acoustic Laboratories recently welcomed their new Director, Dr Brent Edwards.

Brent has a distinguished international reputation in the hearing industry, having spent 22 years in Silicon Valley heading research and innovation development at major hearing aid companies and hearing device startups. He has made presentations at over 100 conferences, is an inventor on over 25 patents, and has published extensively in professional and trade publications on technology and market trends. He founded the Starkey Hearing Research Centre, which is currently a leading site for research in hearing impairment, and his research into the effect of hearing technology on cognition created an international growth of research in this area.

He is an elected Fellow of the Acoustical Society of America and his graduate education is in electrical engineering and psychology. Brent is bringing a strong innovation focus to NAL, with a particular emphasis on developing practical solutions for real-world technology gaps, whilst still maintaining NAL’s core role of providing scientific research for the public good.