Lilly Leans Into Hearing Loss in $1.12B+ Gene Editing Pact With Seamless

A contemporary art collage depicting a giant ear listening to a message bubble while covering it with a hand. The concept of taking in a useful experience or overhearing a new idea.

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The deal will help bolster Eli Lilly’s growing hearing loss portfolio, which is anchored by the gene therapy AK-OTOF.

Eli Lilly is bolstering its hearing loss portfolio through a partnership with Seamless Therapeutics that could be worth more than $1 billion down the line.

The companies did not provide a detailed financial breakdown of the deal, only revealing that it is worth more than $1.12 billion, including an upfront commitment plus development and commercial milestones. On top of this, Seamless will also be eligible for tiered royalties on products that reach the market, according to a press announcement on Wednesday.

The centerpiece of the agreement is Seamless’ drug design engine that can produce site-specific recombinases, which are enzymes that can be used to manipulate DNA sequences. These molecules, in turn, can correct target mutations in certain genes. According to the biotech’s website, recombinases can precisely delete or insert large stretches of DNA “without introducing additional mutations.”

Lilly will leverage Seamless’ platform to target mutations relevant to hearing loss. The pharma will get exclusive licenses over an undisclosed number of programmed recombinases to push into the clinic and to commercialization.

Wednesday’s partnership with Seamless will help Lilly build out its growing hearing loss portfolio, which is anchored by the gene therapy AK-OTOF. Obtained in the $487 million takeover of Akouos in October 2022, AK-OTOF works by delivering a functioning copy of the otoferlin gene to the hair cells in the cochlea. Some 200,000 people globally have hearing loss linked to otoferlin mutations.

In January 2024, Lilly announced that AK-OTOF restored the hearing of an 11-year-old boy within 30 days of dosing. At the time of treatment, the patient had been suffering from “profound hearing loss” since birth, the pharma said.Thirty days after receiving AK-OTOF, the boy eventually reached normal hearing for some sound frequencies.

Then, in May last year, Lilly made another hearing loss play with an up to $1.3 billion agreement with Rznomics and its RNA editors. Rznomics’ platform uses a ribozyme loaded with a therapeutic RNA, resulting in a complex molecule that Lilly can then use to target RNA transcripts relevant to heritable forms of deafness. The partners have not provided a detailed financial breakdown for the deal.

Meanwhile, Regeneron is preparing to file a hearing loss gene therapy called DB-OTO with the FDA. The therapy also tackles otoferlin mutations and restored hearing in 11 of 12 patients in a Phase I/II trial.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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