- Collaboration gene therapy product candidate, DB-OTO, on track to enter clinical testing in 2022; two additional gene therapy programs for congenital, monogenic forms of hearing loss in development under the collaboration
- Decibel to receive $10 million extension payment from Regeneron
BOSTON, Nov. 22, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced that Regeneron has extended the research term of its collaboration with the Company to discover and develop gene therapies for hearing loss. 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.
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.
About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibel’s pipeline, including its lead gene therapy product candidate, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of creating a world of connection for people with hearing and balance disorders. For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow us on Twitter.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Decibel’s strategy, future operations, prospects, plans, objectives of management, the therapeutic potential for Decibel’s product candidates and preclinical programs, the expected timeline for submitting investigational new drug applications and achieving other planned milestones, the Company’s collaboration with Regeneron and the sufficiency of Decibel’s existing cash resources for the period anticipated, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Decibel may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: whether the collaboration with Regeneron will be successful, uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials, the timing of and Decibel’s ability to submit and obtain approval to initiate clinical development of its product candidates, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, whether Decibel’s cash resources are sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, uncertainties related to the impact of the COVID-19 pandemic on Decibel’s business and operations, as well as the risks and uncertainties identified in Decibel’s filings with the Securities and Exchange Commission (SEC), including those risks detailed under the caption “Risk Factors” in Decibel’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021 and in other filings Decibel may make with the SEC. In addition, the forward-looking statements included in this press release represent Decibel’s views as of the date of this press release. Decibel anticipates that subsequent events and developments will cause its views to change. However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Decibel’s views as of any date subsequent to the date of this press release.