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AGTC - Applied Genetic Technologies News Story

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Last Trade - 07/05/21

Sector
Healthcare
Size
Small Cap
Market Cap £118.8m
Enterprise Value £87.9m
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TeamedOn and AGTC Announce a Licensing Agreement Advancing X-Linked Retinoschisis Gene Therapy Program

Tue 13th April, 2021 12:00pm
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- AGTC Transfers Clinical Trial Materials and Phase 1/2 Data To TeamedON -

ROCKVILLE, Md., April 13, 2021 (GLOBE NEWSWIRE) -- TeamedOn International,
Inc., a biotechnology company dedicated to advancing gene therapies for rare
diseases, including ophthalmic indications, and Applied Genetic Technologies
Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical
trials of adeno-associated virus (AAV)-based gene therapies for the treatment
of rare diseases, today announced a licensing agreement to advance gene
therapy to treat X-linked retinoschisis (XLRS), an inherited disease that
causes loss of vision due to degeneration of the retina in males. Under the
terms of the agreement, AGTC will provide TeamedOn with the clinical trial
material, pre-clinical and clinical data generated for the development of
AGTC’s investigational intravitreal gene therapy candidate,
rAAV2tYF-CB-hRS1.

“The license between AGTC and TeamedOn re-opens the possibility of a
much-needed treatment for individuals with XLRS,” said Peter Mu, CEO of
TeamedOn. “TeamedOn is very pleased to be able to build on AGTC’s efforts,
carry on their investment in XLRS to bring potential benefit to patients.”

Under the agreement, TeamedOn will conduct all activities required to
reinitiate clinical development of the program. AGTC will be eligible to
receive milestones and royalties based on clinical progress.

“There is no cure for XLRS, and patients living with this disease have an
urgent need for disease-modifying therapies that have the potential to
stabilize and/or improve their long-term vision outcomes,” said Dr. Paul
Yang, Assistant Professor of Ophthalmology at the Oregon Health and Sciences
University, who was a clinical investigator for AGTC’s prior XLRS Phase 1/2
clinical trial and recently engaged by TeamedOn. “Intravitreal injection of
this gene therapy for XLRS previously demonstrated a reasonable safety
profile. When administered through subretinal injection as TeamedOn is
planning, this investigational gene therapy may have an increased likelihood
of producing detectable biological activity.”

AGTC discontinued its XLRS clinical program and development of
rAAV2tYF-CB-hRS1 in 2018 because defined efficacy endpoints were not met using
intravitreal injection.

“We are excited at the prospect of TeamedOn taking a license for this
program to explore the opportunity for subretinal injection of
rAAV2tYF-CB-hRS1 to provide potential clinical benefit to mitigate the
devastating impact on the vision of individuals with XLRS for whom there are
no effective treatments,” said Sue Washer, President and CEO of AGTC.

Forward-Looking Statements
This release contains forward-looking statements that reflect AGTC's plans,
estimates, assumptions and beliefs, including statements regarding the
licensing agreement between AGTC and TeamedOn International, Inc. for AGTC to
provide TeamedOn with the clinical trial material, pre-clinical and clinical
data generated for the development of AGTC’s investigational intravitreal
gene therapy candidate, rAAV2tYF-CB-hRS1. 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, potential growth
opportunities, potential market opportunities, the effects of competition and
the impact of the COVID-19 pandemic, including the impact on its ability to
enroll patients. 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; the direct and
indirect impacts of the ongoing COVID-19 pandemic on our 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 our most recent annual or
quarterly report and in other reports we have 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. 

About TeamedOn
TeamedOn International, Inc. (TeamedOn) (https://www.TeamedOn.com) is
advancing gene therapies for rare diseases and currently focused on ophthalmic
indications. We are developing innovative medicine to treat inherited retinal
disorders (IRDs) and other eye diseases with significant unmet medical need.
In addition to our internal R&D programs, we also seek partners for
collaboration or co-development. Our goal is to restore sight and prevent
vision loss for patients all around the world. TeamedOn is privately funded
and located in Rockville, MD.

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 a leader in designing and constructing all
critical gene therapy elements and bringing them together to develop
customized therapies that address real patient needs. AGTC’s most advanced
clinical programs leverage its best-in-class technology platform to
potentially improve vision for patients with an inherited retinal disease.
AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and
achromatopsia (ACHM CNGB3 and ACHM CNGA3). Its preclinical programs build on
the Company’s industry leading AAV manufacturing technology and scientific
expertise. AGTC is advancing multiple important pipeline candidates to address
substantial unmet clinical need in optogenetics, otology and CNS disorders. In
recent years AGTC has entered into strategic partnerships with companies
including Otonomy, a biopharmaceutical company dedicated to the development of
innovative therapeutics for neurotology, and Bionic Sight, an innovator in
the emerging field of optogenetics and retinal coding. 

TeamedOn PR CONTACTS:
Peter Mu, PhD, MBA
CEO
TeamedOn International, Inc.
(301) 461-1617 
Peter_Mu@teamedon.com

AGTC IR/PR CONTACTS: 
David Carey (IR) or Glenn Silver (PR)
Lazar FINN Partners
T: (212) 867-1768 or (646) 871-8485
david.carey@finnpartners.com or glenn.silver@finnpartners.com

AGTC Corporate Contacts:
Bill Sullivan
Chief Financial Officer
Applied Genetic Technologies Corporation
T: (617) 843-5728  
bsullivan@agtc.com

Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: (617) 413-2754
spotter@agtc.com

(https://www.globenewswire.com/NewsRoom/AttachmentNg/542616ce-01ae-469d-b4ff-5285f7e0584e)



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