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Hearing Loss Cell Therapy Licensed in $625M Deal

Man with headphones

(StockSnap, Pixabay)

18 July 2019. A biotechnology company developing regenerative treatments for various disorders is licensing its lead therapy candidate for hearing loss to Astellas Pharma. The deal could bring Frequency Therapeutics in Woburn, Massachusetts as much as $625 million if all parts of the agreement are fulfilled.

Frequency Therapeutics is a four year-old company developing small molecule, or low molecular weight, drugs that stimulate dormant progenitor cells in the body to treat a number of disease areas: skin disorders, muscle regeneration, gastrointestinal diseases, and hearing loss. Progenitor cells perform something like stem cells, in that they can transform into functioning cells and tissue. But progenitor cells are more mature than stem cells and have a more limited range of tissues to which they can transform.

The company’s technology is based on discoveries in the bioengineering lab of Robert Langer at MIT and Jeffrey Karp’s regenerative medicine group at Harvard Medical School. Langer and Karp identified pathways for activating and stimulating dormant progenitor cells in the body to divide and differentiate, much like skin or intestinal cells. The target progenitor cells express proteins known as leucine-rich repeat-containing G protein-coupled receptor 5, or Lgr5+, which the company says it activates for cell division and transformation.

Frequency’s first product addresses sensorineural hearing loss, a common condition caused by damage to the inner ear. In that part of the ear, hair cells that act as sensory receptors and the auditory nerve can become damaged from a number of causes, including genetics, trauma, advanced age, and repeated exposure to loud noise. The company’s lead product code-named FX-322 is designed to activate progenitor cells in the ear. FX-322 is injected in the middle ear, then infuses into the inner ear where the damage occurs.

In April, Frequency Therapeutics reported results of an early- and mid-stage clinical trial which show FX-322 treatments caused no serious adverse effects, the main endpoint or objective of the trial. But the company also said the findings show signs of hearing restoration in “in multiple FX-322 treated patients.” A larger mid-stage clinical trial is planned for later this year.

In the agreement with Astellas Pharma, based in Tokyo, Frequency and Astellas will share further development and commercialization of FX-322, with Frequency responsible for the U.S. and Astellas taking the lead in the rest of the world. The two companies will collaborate on further clinical trials and coordinate commercial launch of FX-322’s branded versions.

Astellas is providing an initial payment of $80 million, and Frequency is eligible for another $545 million in payments for reaching designated development and commercial milestones. Frequency will also be eligible for royalties on sales of products from the agreement.

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