Lineage Cell Therapeutics — ANP1 for Treatment of Auditory Neuropathy

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

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.”

Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include four allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer and (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy.

 

I wish that in 5-10 years most of these biotech companies would have their medicine on the market. Life with just slight hearing loss and tinnitus is pure hell, it has literally destroyed my happiness. Because of that am living in total darkness.

 

Genentech is funding them, this sounds promising.

EDIT: I wasn't entirely correct there. Their partnership with Genentech is for a different drug.

 

2022 has been the year of optimism for me so far. A couple of years ago things were so dark but all of the research going on is giving me comfort.

 

I’m confused. Does "treatment of auditory neuropathy spectrum disorders" mean tinnitus?

 

It is a bit confusing, I'm hoping they're going to clarify things down the road.

 

I think yes, tinnitus is one of them. Since any damage to the auditory path can cause tinnitus, then it's most likely.

 

I don't understand any of this. Seems like a funding drive for another failed biotech.

 

They aren't a failed biotech. I checked them out, they are pretty successful from what I read about them.

 

Wondering how this type of treatment would work for pain hyperacusis. But we are probably half a decade further before this treatment would become widely available. Company looks legit though.

 

It is. It sits at middle of biotech scale with analysts.

Dry age-related macular degeneration and cell therapy are very crowed research areas.

Shares traded have heavy hedge fund and swing trader involvement.

Owned a fair number of shares between July 2020 and July 2021 - had a solid return and my ownership timing was good.

Presently have a newer very small position at a lower price - down a few dollars.

 

I'm from the EU and would like to invest in Frequency Therapeutics, Otonomy as well as Lineage Cell Therapeutics. How can I when I am from the EU? I couldn't find a site where I can from EU as all of them were only for the US.

 

There are plenty of brokers that sell US stocks.

 

I wonder what the difference is between Lineage Cell Therapeutics' and Rinri Therapeutics' approach? Does anyone have any insight?

 

I find the DEGIRO platform great for investing. Hope your investments pay off.

Not usually a good idea to follow your heart with investing. I have learned that the hard way

Best of luck. Here is the link. Practically zero fees. Easy to set up and get investing.

https://www.degiro.com/

Note. All US stocks are on this. I have bought and sold FREQ.

 

Cell Therapy Treatment for Hearing Loss:...