On November 22, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Regeneron has extended the research term of its collaboration with the Company to discover and develop gene therapies for hearing loss (Press release, Decibel Therapeutics, NOV 22, 2021, View Source [SID1234595908]). The research term will be extended to November 15, 2023, and Regeneron will pay Decibel an extension fee of $10 million in Q4 of 2022.

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Under the collaboration launched in 2017, Decibel is developing three gene therapy programs targeting congenital, monogenic hearing loss with Regeneron. Decibel plans to initiate in 2022 a Phase 1/2 clinical trial of DB-OTO, the Company’s lead gene therapy product candidate, designed to provide hearing to individuals born with profound hearing loss due to mutation of the otoferlin gene. Decibel is also advancing AAV.103 and AAV.104, gene therapy programs targeting other monogenic forms of hearing loss, with Regeneron. AAV.103 aims to restore hearing in individuals with mutations in the GJB2 gene, and AAV.104 aims to restore hearing in individuals with mutations in the STRC gene.

"Decibel and Regeneron scientists have worked closely to advance our gene therapy pipeline for the treatment of congenital, monogenic hearing loss, bringing our lead program, DB-OTO, within sight of the clinic. We are pleased that Regeneron has elected to extend the research term, which extends our access to Regeneron’s world-leading genomic and genetic technologies, and therapeutic discovery and development expertise," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "This collaboration, which plays to each party’s strengths, is an important part of our ability to accelerate the discovery and development of innovative genetic therapies for patients in need."

"The inner ear is a highly promising frontier for gene therapy, and we believe that the programs being developed in collaboration with Decibel could lead to novel medicines that help people with congenital, monogenic hearing loss," said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer, Regeneron. "We’re pleased to extend this successful collaboration, which is an important component of Regeneron’s growing genetics medicine portfolio. Regeneron and Decibel will continue to work together to combine novel gene therapy technologies with deep biologic expertise, so as to bring life-changing medicines to those suffering with hearing loss."

Through the collaboration, Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel’s goal of discovering new medicines for congenital, monogenic hearing loss. Regeneron also directly participates in and provides financial support for Decibel’s research and development efforts under the collaboration through milestone payments and reimbursement intended to fund approximately half of the costs of the collaboration programs. Decibel retains worldwide development and commercialization rights to the product candidates being developed in the collaboration and will pay Regeneron tiered royalties based on net sales.