Frequency Therapeutics — Hearing Loss Regeneration

Discussion in 'Research News' started by RB2014, Dec 8, 2016.

    1. ChrisBoyMonkey

      ChrisBoyMonkey Member Podcast Patron

      Location:
      Los Angeles, CA
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      U.S. Army/Field Artillery Veteran
      True... which is why I would try to get the Tesla solar panel with it ;)
       
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    2. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      For now... for now!
       
    3. Earing
      No Mood

      Earing Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      noise
      I talked with a Tesla owner about charging. He said it takes 100 hours with a regular plug to charge but the Tesla chargers have the equivalent of 64 220v dryer plugs all at once, and it only takes 15 minutes.
       
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    4. JohnAdams
      Starving

      JohnAdams Member Benefactor Hall of Fame

      Location:
      here
      Tinnitus Since:
      it started.
      Cause of Tinnitus:
      hearing loss
      What's the alternative? Is there even one on the horizon?
       
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    5. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      There are alternatives that are maturing... China is leading the pack. But still nowhere near enough to cover global energy needs.

      But hey,
      Rome was not built in one day...
      Hearing cells were not regenerated in one day...
      Energy transitions will take time... every step we take is one closer to the end goal.

      If more people move to electric cars, the final switch will just become easier, right? Just connect another source to the grid and we’re there!

      A few graphs on solar in attachment.

      Now... back to Frequency Therapeutics?
       

      Attached Files:

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    6. Deathtotinni

      Deathtotinni Member

      Location:
      Parkville Maryland
      Tinnitus Since:
      9/10/17
      Cause of Tinnitus:
      Qtip and maybe a sound..who knows
      I've been inactive and trying to get used to my tinnitus. Stupidly went to fireworks... Did plug my ears but my tinnitus has since spiked. Though it could be due to a peptide I’m taking... Sooo I’m back.

      What’s the news with Frequency Therapeutics?
       
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    7. JohnAdams
      Starving

      JohnAdams Member Benefactor Hall of Fame

      Location:
      here
      Tinnitus Since:
      it started.
      Cause of Tinnitus:
      hearing loss
      They said they saw good results from their last trial, no real details. They are going to run by a podium like Sonic the Hedgehog in September and say something about it into the microphone and then presumably start phase 2.
       
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    8. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      Screenshot 2019-07-17 at 16.00.51.png

      Astellas Obtains the Exclusive Rights to Develop and Commercialize FX-322 in Ex-U.S. Markets; Frequency Retains U.S. Rights

      Frequency will Receive $80 Million Upfront from Astellas with the Potential of up to $545 Million in Future Milestone Payments as well as Double-Digit Royalties

      TOKYO and WOBURN, Mass., July 17, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Frequency Therapeutics, Inc. today announced that they have entered into an exclusive license agreement to develop and commercialize Frequency’s regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss, the most common type of hearing loss. At present, there are no approved therapeutic options for sensorineural hearing loss.

      Under the terms of the agreement, Astellas will be responsible for the development and commercialization of FX-322 outside of the U.S. and Frequency will be responsible for U.S. development and commercialization. The companies will be jointly responsible for conducting global clinical studies and coordinating commercial launch activities. Frequency will receive an upfront payment of $80 million and may also receive up to an additional $545 million based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory.

      Frequency recently completed a Phase 1/2 clinical study in the U.S. in which FX-322 was observed to be well-tolerated following a single intratympanic injection, with no serious adverse events. Improvements in hearing function were observed in multiple FX-322 treated patients. Frequency plans to initiate a Phase 2a study in the fourth quarter of 2019.
       
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    9. Manny
      Dead

      Manny Member Benefactor Hall of Fame

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      Cause of Tinnitus:
      central gain << NIHL
      Nice! Seems good news as an "efficacy indicator".
       
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    10. Gorbeh3

      Gorbeh3 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Hearing Loss
      WE GONNA MAKE IT BOIS. KEEP YOUR HEADS UP.
       
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    11. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      So Astellas has global rights for development and commercialisation except for the US for which Frequency Therapeutics is responsible. I hope it will be truly global effort and not just Japan. But very good news and a strong validation for the technology by a large pharma that has seen all the data to date.
       
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    12. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      They have facilities in the Americas, Asia/Oceania and Europe.

      https://www.astellas.com/en/about/subsidiaries-and-locations
       
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    13. SergioN

      SergioN Member

      Tinnitus Since:
      25/07/2005
      Cause of Tinnitus:
      Acoustic trauma + ototoxicity
      Has any other candidate in the past arrived so far like this? Is this really a unique moment in the history of hearing? I hope so.
       
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    14. tarmaced
      Wtf

      tarmaced Member

      Tinnitus Since:
      2004 (mild) 2018 (not so mild)
      Cause of Tinnitus:
      Ear infections, compounded by noise exposure
      I was wondering this as well? Let's say the benchmark is 100 million+ in funding injection and a partnership with a major pharma distributor on the basis of hair cell regeneration? Anyone know of this?
       
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    15. Candy

      Candy Member Benefactor Advocate

      Tinnitus Since:
      06/2016
      Cause of Tinnitus:
      Unidentified
      How much hearing loss does one need to have to be a candidate for the treatment though? I know I’m getting ahead of myself...
       
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    16. tarmaced
      Wtf

      tarmaced Member

      Tinnitus Since:
      2004 (mild) 2018 (not so mild)
      Cause of Tinnitus:
      Ear infections, compounded by noise exposure
      My thought as well - I have 30 dB hearing loss so I should fall with a foot in the camp whichever way it wings for, high or low, rights XD.

      The pattern of cells remind me of honeycomb. I always imagine that, like bees, you may be better off starting with a pre-existing pattern. Fingers crossed it works for all though!
       
    17. Chad Lawton

      Chad Lawton Member

      Tinnitus Since:
      2/19/18
      Cause of Tinnitus:
      Possible Ototoxicity + Noise Exposure
      I take that as great news! Astella is quite a large corporation. Their market cap is 28 billion. To put it in perspective, Pfizer has a market cap of 240 billion. 28 billion is definitely not a hole in the wall drug company.
       
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    18. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
      Tinnitus Since:
      4-15-2017
      Cause of Tinnitus:
      Acoustic trauma
      I will fly to Japan if I have to!!!
       
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    19. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
      Tinnitus Since:
      4-15-2017
      Cause of Tinnitus:
      Acoustic trauma
      I am buying Astellas stock and holding.
       
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    20. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      Why go to Japan when you will be able to get it in the US?
       
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    21. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      I thought we were going to have to wait 10 weeks for any news to come out. This is crazy good news.
       
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    22. Staceyyy

      Staceyyy Member

      Tinnitus Since:
      3/102018
      Cause of Tinnitus:
      SSHL from a kiss on the ear
      This drug is my only hope, this is great news. I have 45 dB hearing loss in one ear with severe tinnitus and mild tinnitus in my other ear that does not have any sort of hearing loss. I hope this drug will help people without hearing loss as well. I still can't believe we haven't come across a single person who participated in the FX-322 clinical trials.
       
    23. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      That's fantastic news.

      My Dad was in pharmaceuticals for 40 years and now retired. He also has tinnitus. He doesn't expect any miracles, having helped bring many drugs to market, he knows the high rate of failure and length of time needed... but also told me he knows one of the investors in this drug and "he is no dummy" according to dad.
       
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    24. Jack Straw
      Balanced

      Jack Straw Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Location:
      US
      Tinnitus Since:
      1990s
      Cause of Tinnitus:
      Infection, Acoustic Trauma
      Seems very promising if they got bought out by such a large pharma company.
       
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    25. Flamingo1

      Flamingo1 Member Benefactor

      Location:
      Orlando, FL
      Tinnitus Since:
      4-15-2017
      Cause of Tinnitus:
      Acoustic trauma
      US will probably take longer.
       
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    26. Mr Mister

      Mr Mister Member

      Tinnitus Since:
      1996
      Cause of Tinnitus:
      Hearing loss, loud music
      I hope that this new licensing deal, $80M USD new capital and Astellas' contribution adds sufficient resources for the development of FX-322. Maybe they can speed up trials by adding Japanese and European facilities and patients. Somebody sent a link earlier stating Frequency Therapeutics has 14 employees. That has to be a major bottleneck in development. If you are convinced you have a billion dollar business you surely have more than 14 employees.

      Statistically only about 30% of drugs that enter phase 2 make it to phase 3 so it's still better to be cautious. However, Astellas would not pay $80M USD for a drug candidate that is only safe. Instead, Astellas has been presented with strong data supporting efficacy of FX-322.

      I am surprised that none of the tier 1 large pharmas like Pfizer, Novartis, Merck, Glaxo, etc made the deal. If it works, it is the biggest medical breakthrough in decades and someone will get a Nobel prize. And the market is so vast that it will be a blockbuster with sales in excess of 1 billion USD. Maybe the reason is that Astellas provided better conditions, valuation and royalty rates or that Frequency Therapeutics retaining US rights was not accepted by some.
       
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    27. Daniel Lion
      Ape-like

      Daniel Lion Member Benefactor

      Location:
      se asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      Understatement...

      It’s awesome news friend... Yes.

      Come on you nerdy capitalists... Make your millions... And help our ears.
       
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    28. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      The testing and research is outsourced and operates under their guidance. So there could be hundreds of scientists employed by them, working in third party labs.
       
    29. BrStan@

      BrStan@ Member

      Location:
      London
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Acoustic trauma
      Have we got any evidence that restoring hearing will reduce tinnitus? Why then hearing aids don't help?
       
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    30. Jack Straw
      Balanced

      Jack Straw Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Location:
      US
      Tinnitus Since:
      1990s
      Cause of Tinnitus:
      Infection, Acoustic Trauma
      Since big pharma just got involved I can only assume that the treatment for this will be very expensive.
       
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