Astellas and Frequency Therapeutics Partner in $600M Deal to Advance Regenerative Therapy FX-322 for Hearing Loss

Today, Astellas and Frequency Therapeutics announced an exclusive licensing agreement to advance the development and commercialization of Frequency’s regenerative therapy, FX-322. This drug is indicated for the treatment of stable sensorineural hearing loss (SSHL), the most common type of hearing loss. Notably, Will McLean, one of Frequency’s co-founders, was named to last year’s MIT Technology Review “35 Innovators Under 35” list.

Many types of human hearing impairment are caused by damage to the hair cells in the inner ear. The World Health Organization (WHO) estimates that over 800 million adults worldwide currently suffer from hearing loss. According to data from the U.S. National Institutes of Health (NIH), approximately 90% of individuals with hearing loss are affected by sensorineural hearing loss. Currently, there are no approved therapies for the treatment of sensorineural hearing loss.

FX-322 is a small-molecule drug combination designed to activate existing progenitor cells in the inner ear through progenitor cell activation (PCA), thereby promoting hair cell regeneration and ultimately reversing biological deficits to restore tissue health. PCA-based regeneration is a novel therapeutic approach that repairs damaged tissue and restores healthy function in a less complex manner, while potentially offering safety advantages over traditional cell and gene therapies.

This method stems from laboratory discoveries in progenitor cell biology by Dr. Robert Langer of the Massachusetts Institute of Technology (MIT) and Dr. Jeff Karp of Harvard Medical School and Brigham and Women’s Hospital. Although Frequency’s current primary research focuses solely on hearing restoration, the PCA Regenerative Platform has the potential to be applied to a wide range of indications, including various degenerative conditions such as demyelinating diseases, dermatological disorders, and gastrointestinal diseases.

Frequency Therapeutics recently completed a Phase 1/2 clinical trial in the United States. The results demonstrated that FX-322 was well-tolerated following a single intratympanic injection, with no serious adverse events reported. Significant improvements in hearing function were observed in multiple patients treated with FX-322. Frequency plans to initiate a Phase 2a study in the fourth quarter of 2019.

Under the collaboration agreement, Astellas will be responsible for the development and commercialization of FX-322 in regions outside the United States, while Frequency will handle its development and commercialization within the United States. The two companies will jointly conduct global clinical trials and promotional activities. Frequency will receive an upfront payment of $80 million and may also be eligible for up to $545 million in subsequent milestone payments based on development and commercialization milestones, as well as future royalties on product sales.

Note: The original text has been abridged.

References:

[1] Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss. Retrieved July 17, 2019, from https://www.astellas.com/en/news/14841

[2] Astellas picks up Frequency's regenerative hearing loss med outside U.S. for $80M. Retrieved July 17, 2019, from https://www.fiercebiotech.com/biotech/astellas-picks-up-frequency-s-regenerative-hearing-loss-med-outside-u-s-for-80m

Headline: Flash | $600 Million to Support Hearing Loss Treatment, Astellas Collaborates on Regenerative Therapy Development

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