Rinri Therapeutics

[Nick47]

Research in the UK, human trials for sensorineural hearing loss in 1-2 years - Rinri Therapeutics

Clinical Development

In the case of hearing loss, it is difficult to assess the impact of a new therapy since the inner ear is very difficult to access. However, the electrode array of a cochlear implant, which is threaded through the cochlea during cochlear implant surgery can double up as an excellent objective measurement tool. Rinri have led a series of studies in which equipment used by clinicians to assess measures of cochlear health and performance has been repurposed and used for longitudinal post-surgical self-assessment. This a fantastic way of evaluating what normal cochlear health looks like in cochlear implant users, generating data that Rinri can compare against when assessing the safety and efficacy of our cell therapy treatments.

First in Human Trials

Rinri is currently preparing regulatory submissions for the first in human clinical trials of Rincell-1, which are due to commence in the near future. Rinri's cells will be administered to adults with severe-to-profound auditory nerve-related hearing loss who are eligible under UK NICE guidance (TA566) to receive a cochlear implant.

Tinnitus Talk Podcast episode from 2019:

→ Episode 5: Hearing In, Tinnitus Out — Prof. Marcelo Rivolta

 

[UKBloke]

Interesting. Are they making a distinction between hair cells and neurons, with the emphasis being on fixing neurons? Bit confused after reading their website.

 

[Nick47]

This is the email I received from Nottingham Biomedical Centre, about the research taking place at Sheffield University.

You MUST meet at least one of the criteria below to complete the survey.

Dear participant,

We would like to invite you to participate in a study conducted by the Nottingham Biomedical Research Centre. We want to explore the views of people with lived experience of hearing loss regarding cell-based therapies for hearing loss.

These therapies rely on a type of cells called progenitor cells. Progenitor cells have an incredible potential: they can be made to turn into any cell type in the human body. Researchers at the University of Sheffield have produced a method to encourage the progenitor cells into becoming ear cells. At present, we are working on developing these cells into a treatment for people with hearing loss.

Do you fit in or more of these groups:

• A cochlear implant user or
• A hearing aid user or
• Diagnosed with auditory neuropathy or
• A heathcare professional working with people with hearing loss or
• A person working for a non-profit organisation supporting people with hearing loss or
• A significant other and/or carer of an individual with hearing loss?

If so, please participate in our anonymous 5-10 min survey to explore the insights of people with lived experience of hearing loss regarding cell-based therapies!

This project is part of a research project conducted by the Nottingham Biomedical Research Centre in collaboration with the University of Nottingham, and it has been reviewed and approved by UoN Research Ethics Committee (198-0123).

The link to the survey is here: https://nottingham.onlinesurveys.ac.uk/towards-cell-based-treatments-for-hearing-loss

Thank you for your help!

If you have any questions, please contact Tia Papoutselou at efstratia.papoutselou@nottingham.ac.uk

I'm not sure if you need to be in the UK or not to complete the survey. It probably doesn't matter.

However, you MUST meet at least one of the criteria above!

Interesting. Are they making a distinction between hair cells and neurons, with the emphasis being on fixing neurons? Bit confused after reading their website.

@UKBloke, I took it as they are not focused on IHC/OHC/synapses but on the auditory nerves. They say about 75% have hearing loss due to damage of these nerves. I have to say I'm not clear myself on this.

 

[UKBloke]

@UKBloke, I took it as they are not focused on IHC/OHC/synapses but on the auditory nerves.

Just took a bit of a deeper dive on this. Long and short from what I can gather:

• In surgical studies they utilised a synchotron x-ray to heatmap the cochlear with the (succesful) aim of targeting a surgical delivery route for their therapy.
• Therapy seems to be stem cell based.
• Current target appears to be spiral ganglion, so we're looking at auditory neuropathy/speech-in-noise/hidden hearing loss type of situation (some studies suggest the tinnitus associated with this may be the low rumbling <1000 Hz type.

 

[Philip83]

New article about Rinri. Three drugs seem to be in the pipeline, with Phase 1 trial for the first drug starting in 2024.

Stem cell therapy: a potential cure for hearing loss?

 

[Nick47]

"Its lead product is Rincell-1, a first-of-its-kind inner ear cell therapy that hopes to recover sensorineural hearing loss, specifically hearing loss caused by damage to the auditory nerves in the cochlea."​

That sort of cleared it up a bit for me. Using more objective measures through the use of Cochlear Implants should be better than speech-in-noise or word recognition tests.

Rinri Therapeutics have the funding and don't need to rely on the dreaded stock market + they are tied to a university!

 

[LAnative]

Looks like HOPE is back on the menu, boys.

 

[Nick47]

Looks like HOPE is back on the menu, boys.

@LAnative, you will need to follow them closely. You are unlikely to see the media coverage and self-promotion you see with some biotechs, which is why they are under the radar.

 

[fletchermunson]

Rinri Therapeutics' Board of Directors still seems to be filled with biotech industry folks, right? Even Frequency Therapeutics liked to mention their connections to Harvard and MIT.

I suppose the hope here is that Rinri Therapeutics do not become publicly traded so as to not puff up their prospects?

 

[Jurger]

As Rinri Therapeutics prepares to begin clinical trials for Rincell-1 in 2024, Rincell-2 (auditory neuron progenitors derived from iPS cells) and Rincell-3 (auditory hair cell progenitors) are being developed as part of the pipeline.

Great news.

 

[jaytee]

Hello, all. Long time occasional lurker, first time poster, going to jump right into it. (My apologies in advance if I break any implicit conventions or rules, please correct me.)

Rinri Therapeutics claims:

It has been possible to derive auditory sensory cells from pluripotent stem cells for some time. However, earlier generations of these cells achieved different degrees of functional maturation, and none demonstrated the capability to restore function. The reason was our impaired understanding of the molecular events involved in normal human auditory development. With this understanding, the Rivolta lab developed the first functionally restorative human auditory sensory cells, through the application of a developmentally informed manufacturing protocol. Under specific laboratory conditions, the Rivolta lab showed that their progenitor cells were able to mature into functional auditory neurons.

This raises some questions for me. They are confidently stating that they now have a correct understanding of the human auditory development at a molecular level after past failures. On what basis if they're preclinical? Do they even have animal models? The one study I see cited states in the abstract only in vitro testing, and testing in an "auditory neuropathy model".

Every one of these labs, public, private, or non-profit affiliated gives me hope as it adds to our body of knowledge on the issue, but I want to have an accurate assessment of what's been accomplished vs. hype.

 

[StoneInFocus]

World's first self-monitored cochlear implant trial opens the door to future hearing loss therapies

In a global first, cochlear implant users have been able to perform their own hearing health recordings from the comfort of their own homes.

Until recently, objectively measuring cochlear health was notoriously difficult. However, a ground-breaking study published in Frontiers in Neurology has overcome this challenge by using the electrode arrays of cochlear implants to gain direct insight into cochlear health. Importantly, since data collection in this study was via participant self-assessment, it enabled regular recordings to be made over long periods of time. Such high intensities of data collection would have been impossible if testing relied on participants attending clinics. The application of this technique has improved the medical understanding of how cochlear health influences the performance of implants, and importantly, may serve to overcome major hurdles in the development of advanced treatments for deafness, including the regenerative cell therapies being developed by Rinri Therapeutics. The approach pioneered by this study, cements Rinri's position as a global leader in the design of effective clinical trials for hearing loss.

The data was collected by experienced adult cochlear implant recipients. They were trained to use the AIM tablet to self-record electrode impedances, electrically-evoked compound action potentials (eCAPs) and electrochochleography (ECochGs). These measures, cumulatively, provide a comprehensive snapshot of an individual's cochlear health.

 

[Nick47]

↑ Yep, this is how they will objectively measure Rincel-1, an auditory nerve regeneration stem cell therapeutic in the upcoming clinical trial. The trial will not start until late 2024/early 2025.

It is basically replacing the speech in noise tests used by other companies, which is more subjective and open to day to day variations.

 

[IndyMLVC]

@LAnative, you will need to follow them closely. You are unlikely to see the media coverage and self-promotion you see with some biotechs, which is why they are under the radar.

I trust the companies that fly under the radar more than the ones that are boasting. It's never the person shouting loudest that I want to pay attention to.

 

[Nick47]

I trust the companies that fly under the radar more than the ones that are boasting. It's never the person shouting loudest that I want to pay attention to.

It's a solid collaboration between Nottingham University, Sheffield University and Rinri Therapeutics. That doesn't mean the outcome is certain, but the preclinical stuff showed it to do what we want it to.

 

[SarahMLFlemmer]

I trust the companies that fly under the radar more than the ones that are boasting. It's never the person shouting loudest that I want to pay attention to.

Smart thinkin'!

 

[fletchermunson]

Does anyone have an idea what their "surgical procedure" would entail to receive their treatment? At least a day in the hospital? Would this hamper widespread availability of their treatment?

 

[Nick47]

Does anyone have an idea what their "surgical procedure" would entail to receive their treatment? At least a day in the hospital? Would this hamper widespread availability of their treatment?

I cannot find the "access point" anywhere in literature. They talk about discovering a new route to the cochlear though.

 

[lolkas]

I cannot find the "access point" anywhere in literature. They talk about discovering a new route to the cochlear though.

I don't think that their procedure is more complicated than a cochlear implant surgery, which is pretty much outpatient.

They want to be able to accurately deliver the drug via the round window, therefore I think they will cut behind the ear and to it like that, or perhaps they will make a small incision to guide a camera + needle to inject via the round window. I saw an interview with Dr. Zheng and he mentioned Rinri Therapeutics. He also touched on his approach and that an outpatient surgery is required.

 

[Muggumbo]

Is it a single procedure or do they have to administer the drug multiple times?

I wonder how one's tinnitus will be affected as the nerve heals/regenerates. Will it start changing in pitch and volume as the healing continues?

Either way, hopefully this proves successful at treating tinnitus as well as deafness.

 

[WillBeNimble]

Can someone get the preclinical data? Restoration of auditory evoked responses by human ES-cell-derived otic progenitors.

 

[annV]

Can someone get the preclinical data? Restoration of auditory evoked responses by human ES-cell-derived otic progenitors.

Attached is the full article. Did you mean that?

 

[WillBeNimble]

Attached is the full article. Did you mean that?

Yup, thank you @annV.

 

[Street Novelist]

Does anyone know the status? Has the clinical trial started yet or will it be later this year?

 

[Nick47]

Does anyone know the status? Has the clinical trial started yet or will it be later this year?

In a word, no. Best guess this time next year. 4-5 patients.

 

[ploughna]

Rinri Therapeutics Announces New Chair as It Approaches First Clinical Trial

Sheffield, UK, April 29, 2024: Rinri Therapeutics, a leader in regenerative cell therapies for sensorineural hearing loss, is pleased to announce the appointment of David Hipkiss as its new Independent Chair. This strategic move comes at a pivotal time as the company prepares to initiate first-in-human trials for its lead asset, Rincell-1.

David brings to Rinri Therapeutics over thirty years of experience in the biotech industry, where he has played key roles in the foundation, financing, and sale of several innovative life sciences companies. His previous leadership positions include CEO and Co-Founder at both Prosonix and Enesi Pharma, and he is presently Executive Chair at AlveoGene. His extensive experience in business development and fundraising in both private and public company settings will greatly benefit Rinri as it enters a critical phase of growth and development.

Utilising its proprietary OSPREY™ platform, Rinri Therapeutics is developing a portfolio of off-the-shelf regenerative cell therapy products designed to address sensorineural hearing loss, a significant global medical challenge. The company's lead asset, Rincell-1, is designed to address neural hearing loss by regenerating auditory neurons and provide a novel treatment for patients with severe-to-profound age-related hearing loss or auditory neuropathy. Having achieved outstanding preclinical safety and efficacy data, Rincell-1 is progressing through CTA enabling studies to enable first-in-human trials in 2025.

Commenting on this, David said, "Hearing loss represents a substantial and growing health challenge where no therapeutic treatments exist. I am excited by the opportunity to join Rinri Therapeutics at this critical juncture and am inspired by the potential of our cutting-edge cell therapies to significantly impact this underserved medical need."

Simon Chandler, CEO of Rinri Therapeutics, said, "Alongside our investors Boehringer Ingelheim Venture Fund, UCB Ventures and Pioneer Group, I'm delighted to welcome David as our new Chair. His guidance will be invaluable as we work towards our first clinical proof of concept data with Rincell-1. The Board would like to thank Nick Higgins, the former Chair, for his service and wish him well in his future endeavours."

 

[ploughna]

Worth a listen - very interesting:

→ Our Vice President, Clinical Operations and Development, Rachel Haines, was invited to speak on First-in-Human Podcast by Vial

 

[Joeseph Stope]

The scientific and clinical team shown on the website gives some reason to hope. Of course, that's what a website is for, but the team seems to have advanced degrees in cell biology, the auditory field, and much more.

Worth watching.

The homepage uses the phrase "regenerative cell therapy..." Did Frequency Therapeutics use that phrase, too, or was it rejuvenation therapy? It's quite a while back.

 

[SmallRonnie]

The scientific and clinical team shown on the website gives some reason to hope. Of course, that's what a website is for, but the team seems to have advanced degrees in cell biology, the auditory field, and much more.

Worth watching.

The homepage uses the phrase "regenerative cell therapy..." Did Frequency Therapeutics use that phrase, too, or was it rejuvenation therapy? It's quite a while back.

I can't remember exactly what wording Frequency Therapeutics used, but it was something along those lines. They were always talking about the activation of progenitor cells.

Regarding Rinri Therapeutics, though, it's nice to have a new potential treatment to look forward to again, but I'm going to keep expectations tamed.

 

[Muggumbo]

Regarding Rinri Therapeutics, though, it's nice to have a new potential treatment to look forward to again, but I'm going to keep expectations tamed.

Even if their treatment doesn't work out, the delivery method they found should be useful to future trials.