AGTC Receives Positive Type C Meeting Feedback from the FDA for the Company’s Design and Operating Procedures of its Planned cGMP Manufacturing Facility
July 26 2022 - 7:00AM
Applied Genetic Technologies Corporation (Nasdaq: AGTC), a
clinical-stage biotechnology company focused on the development and
potential commercialization of adeno-associated virus (AAV)-based
gene therapies for the treatment of rare and debilitating diseases
with an initial focus on inherited retinal diseases, today
announced that the U.S. Food and Drug Administration (FDA) provided
favorable feedback on the Current Good Manufacturing Practice
(cGMP) design of AGTC’s manufacturing facility. In its feedback
from a recent Type C meeting, the FDA concurred the facility design
and proposed operating procedures are appropriate to support the
cGMP manufacture of recombinant AAV drug substance.
In May 2022, AGTC announced that it had
completed construction of the manufacturing facility’s exterior
structure and the FDA’s feedback on the interior design of the
facility helps assure the potential successful completion of next
phase of construction. Initial operations at the facility are
expected to begin in 4Q 2022 with GMP capabilities expected to be
finalized in 1Q 2023.
“With the FDA’s feedback, we are pleased to be
on-track with the build out of our cGMP manufacturing facility,
which is crucial in supporting the late-stage clinical development
and potential commercialization of our lead XLRP and ACHMB3
programs,” said Eduardo Jacobo, AGTC’s Senior Vice President, GMP
Manufacturing. “The on-going challenges and costs associated with
external vendors underscore the value of developing a manufacturing
facility specifically designed and prioritized to meet the needs
and timelines for the development of our drug candidates, including
AGTC-501 for XLRP, which we recently reported positive three-month
interim data. As we continue to advance development of this
promising candidate, our new facility will play a crucial role in
its commercialization should it receive FDA approval. We expect the
facility will also play an important role in support of our
promising pipeline of additional clinical and pre-clinical
programs.”
In May 2022, AGTC announced positive three-month
interim results from the Skyline Phase 2 expansion trial of
AGTC-501, demonstrating robust improvements in visual sensitivity,
the trial’s primary efficacy endpoint, in multiple patients three
months after dosing, with a 62.5% response rate in dose group B and
a 25% response rate in dose group A. This is well above the
statistically significant 50% response rate the Vista Phase 2/3
trial for AGTC-501 is powered to detect.
About AGTC
AGTC is a clinical-stage biotechnology company
developing genetic therapies for people with rare and debilitating
ophthalmic, otologic and central nervous system (CNS) diseases.
AGTC is designing and constructing critical gene therapy elements
and bringing them together to develop customized therapies with the
potential to address unmet patient needs. AGTC’s most advanced
clinical programs in XLRP and ACHM CNGB3 leverage its technology
platform to potentially improve vision for patients with inherited
retinal diseases. Its preclinical programs build on the AGTC’s AAV
manufacturing technology and scientific expertise. AGTC is
advancing multiple pipeline candidates to address substantial unmet
clinical needs in optogenetics, otology and CNS disorders, and has
entered into strategic collaborations with companies including
Bionic Sight, Inc., an innovator in the emerging field of
optogenetics and retinal coding, and Otonomy, Inc., a
biopharmaceutical company dedicated to the development of
innovative therapeutics for neurotology.
Forward-Looking Statements
This release contains forward-looking statements
that reflect AGTC's plans, estimates, assumptions and beliefs,
including statements about the expected timing for completion of
the manufacturing facility and the potential for the new
manufacturing facility to support the development and
commercialization of AGTC’s pipeline programs, the potential of the
AGTC’s gene therapy platform and the strength of its XLRP and ACHM
B3 clinical programs, the potential of AGTC-501 as a treatment for
XLRP, the ability to use the interim Skyline clinical trial results
as a predictor of the success of the final Skyline and Vista
clinical trial results and whether these results will support
future regulatory filings for AGTC-501. Forward-looking statements
include information concerning possible or assumed future results
of operations, financial guidance, business strategies and
operations, preclinical and clinical product development and
regulatory progress and the expected timing thereof, potential
growth opportunities, potential market opportunities and the
effects of competition. Forward-looking statements include all
statements that are not historical facts and can be identified by
terms such as "anticipates," "believes," "could," "seeks,"
"estimates," "expects," "intends," "may," "plans," "potential,"
"predicts," "projects," "should," "will," "would" or similar
expressions and the negatives of those terms. Actual results could
differ materially from those discussed in the forward-looking
statements, due to a number of important factors. Risks and
uncertainties that may cause actual results to differ materially
include, among others: gene therapy is still novel with only a few
approved treatments so far; AGTC cannot predict when or if it will
obtain regulatory approval to commercialize a product candidate or
receive reasonable reimbursement; uncertainty inherent in clinical
trials and the regulatory review process; risks and uncertainties
associated with drug development and commercialization; risks and
uncertainties relating to the construction and operation of a cGMP
manufacturing facility; risks and uncertainties related to funding
sources for our development programs and manufacturing facility;
the direct and indirect impacts of the ongoing COVID-19 pandemic on
the Company’s business, results of operations, and financial
condition; factors that could cause actual results to differ
materially from those described in the forward-looking statements
are set forth under the heading "Risk Factors" in the Company's
Annual Report on Form 10-K for the fiscal year ended June 30, 2019,
as amended, filed with the SEC. Given these uncertainties, you
should not place undue reliance on these forward-looking
statements. Also, forward-looking statements represent management's
plans, estimates, assumptions and beliefs only as of the date of
this release. Except as required by law, we assume no obligation to
update these forward-looking statements publicly or to update the
reasons actual results could differ materially from those
anticipated in these forward-looking statements, even if new
information becomes available in the future.
IR CONTACT: David CareyLazar FINN
PartnersT: (212) 867-1768david.carey@finnpartners.com
Corporate Contacts:Jonathan LieberChief
Financial OfficerApplied Genetic Technologies CorporationT: (617)
843-5778 jlieber@agtc.com
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