Otonomy and AGTC Present Preclinical Results Supporting Selection of Product Candidate for GJB2 Gene Therapy Hearing Loss Pro...
May 12 2020 - 8:00AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today announced preclinical results from the company’s
gene therapy collaboration with Applied Genetic Technologies
Corporation (Nasdaq: AGTC) that support the selection of a product
candidate for development as a treatment for gap junction beta-2
(GJB2) deficiency, the most common cause of congenital hearing
loss. These results are being presented during the American Society
of Gene & Cell Therapy (ASGCT) 23rd Annual Meeting being held
virtually May 12-15, 2020.
“Working with AGTC, we have identified novel and
proprietary capsids that are capable of transducing support cells
of the cochlea, which are the relevant target cells for treating
GJB2 deficiency," said David A. Weber, Ph.D., president and chief
executive officer of Otonomy. “The selection of a lead capsid and
other components for continued development of a GJB2 gene therapy
candidate is supported by cochlea explant studies in multiple
rodent species as well as in vivo studies in non-human primates
that are summarized in today’s ASGCT presentation.”
The joint poster presentation by Otonomy and AGTC demonstrate
the following:
- A gene of interest can be expressed in cochlear cells relevant
to GJB2 rescue, including support cells of the organ of Corti and
spiral limbus, and fibrocytes of the spiral ligament.
- The tropism and gene expression level in support cells is
higher for these novel capsids than for previously reported capsids
used in the otic field.
- Consistent gene expression can be observed in support cells
throughout the cochlea for at least 12 weeks following a single
local injection.
- None of the novel AAV capsids evaluated for further development
exhibited signs of cellular toxicity.
In October 2019, Otonomy and AGTC announced a strategic
collaboration to co-develop and co-commercialize an AAV-based gene
therapy to restore hearing in patients with sensorineural hearing
loss caused by a mutation in the GJB2 gene.
About OtonomyOtonomy is a biopharmaceutical
company dedicated to the development of innovative therapeutics for
neurotology. The company pioneered the application of drug delivery
technology to the ear in order to develop products that achieve
sustained drug exposure from a single local administration. This
approach is covered by a broad patent estate and is being utilized
to develop a pipeline of products addressing important unmet
medical needs including Ménière’s disease, hearing loss, and
tinnitus. For additional information please visit
www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to expectations regarding the potential benefits,
development activity and advancement of preclinical programs; the
potential benefits of and activity under the collaboration
agreement between AGTC and Otonomy, including but not limited to
development activity; and statements by Otonomy’s president and
CEO. Otonomy’s expectations regarding these matters may not
materialize, and actual results in future periods are subject to
risks and uncertainties. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
these risks and uncertainties, including but not limited to: the
uncertainties inherent in the clinical drug development process,
including, without limitation, Otonomy’s ability to adequately
demonstrate the safety and efficacy of its product candidates and
the nonclinical and clinical results for its product candidates,
which may not support further development; Otonomy’s ability to
obtain regulatory approval for its product candidates; the risks of
the occurrence of any event, change or other circumstance that
could give rise to the termination of the collaboration agreement
between AGTC and Otonomy; competition in the biopharmaceutical
industry; Otonomy’s dependence on third parties to conduct
nonclinical studies and clinical trials; Otonomy’s dependence on
third parties for the manufacture of its product candidates;
Otonomy’s ability to protect its intellectual property related to
its product candidates in the United States and throughout the
world; expectations regarding potential therapy benefits, market
size, opportunity and growth; Otonomy’s ability to manage operating
expenses; implementation of Otonomy’s business model and strategic
plans for its business, products and technology; and other risks.
Information regarding the foregoing and additional risks may be
found in the section entitled "Risk Factors" in Otonomy’s Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the "SEC") on May 7, 2020, and Otonomy’s future reports
to be filed with the SEC. The forward-looking statements in this
press release are based on information available to Otonomy as of
the date hereof. Otonomy disclaims any obligation to update any
forward-looking statements, except as required by law.
Contacts:
Media Inquiries:Spectrum ScienceChloé-Anne RamseyVice
President404.865.3601 cramsey@spectrumscience.com
Investor Inquiries:Westwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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