Regeneron gains gene therapy programmes for hearing loss via Decibel buy
Gene TherapyLicense out/inAcquisition
Regeneron Pharmaceuticals said Wednesday that it reached a definitive agreement to acquire Decibel Therapeutics, giving it access to key gene therapy programmes for hearing loss. The proposed deal values Decibel at about $109 million, or up to approximately $213 million if contingent value right (CVR) milestones are achieved.
Specifically, Regeneron has agreed to pay $4.00 per share of Decibel stock in cash, representing a 43% premium from the latter's closing price on August 8. The deal also calls for an additional non-tradeable CVR of up to $3.50 per share in cash upon the achievement of certain clinical development and regulatory milestones for DecibelDecibel's lead cell-selective, AAV gene therapy candidate DB-OTO, within specified time periods.
Long-running partnership
The companies initially forged a collaboration in 2017, later extended in 2021, aimed at developing three gene therapy programmes targeting different forms of congenital, monogenic hearing loss. DB-OTO, which Regeneron and Decibel are co-developing, is currently in Phase I/II testing in the CHORD trial to evaluate its ability to provide durable physiological hearing to people with profound, congenital hearing loss caused by mutations in the otoferlin gene.
George Yancopoulos, chief scientific officer at Regeneron, noted that DB-OTO "will soon reach patients in its first clinical trial, offering new promise to children with this rare form of congenital hearing loss, as well as potential proof-of-concept for future gene therapies addressing more common forms of genetic hearing loss." The companies had originally anticipated DB-OTO would head into the clinic in 2022.
Meanwhile, DecibelDecibel's preclinical pipeline also includes AAV.103 for patients with GJB2-related hearing lossGJB2-related hearing loss, and AAV.104 for those with stereocilin-related hearing lossstereocilin-related hearing loss. The company launched in 2015 with $52 million Series A financing led by Third Rock Ventures.
Under the buyout deal, CVR holders would become entitled to receive contingent payments of $2.00 per share in cash upon a fifth participant being administered with DB-OTO in a clinical trial by the end of 2024. CVR holders would also be eligible for payments of $1.50 per share in cash when a first participant given DB-OTO is enrolled in a registration-enabling trial; or if a biologics application for DB-OTO is accepted for review by regulators in the US, EU or the UK; or an equivalent application is accepted for review by regulators in Germany, France, Italy or Spain – whichever comes first, so long as it occurs by December 31, 2028.
Regeneron has other gene therapy interests, including a licensing agreement with ViGeneron to develop a gene therapy product based on engineered recombinant AAVs to treat an inherited retinal disease. Meanwhile, hearing loss is an active area for gene therapy research, with Eli Lilly acquiring Akouos for $487 million last year gaining the latter's candidates for sensorineural hearing loss.
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