Adverum Presents Data at ASGCT Further Supporting Phase 2 Development Plans for ADVM-022
May 17 2022 - 4:05PM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene
therapy company targeting unmet medical needs in ocular and rare
diseases, today will announce new data from the ADVM-022
development program in wet age-related macular degeneration (wet
AMD). The data being presented during the American Society of Gene
and Cell Therapy (ASGCT) 2022 Annual Meeting in Washington, D.C.
and virtually, shows results of the non-human primate (NHP) studies
that provide support for the new 6 X 10^10 vg/eye (6E10) dose that
Adverum intends to include in its next clinical trial.
“These new data suggest the 6x10^10 vg/eye dose may provide
therapeutic levels of aflibercept in the clinic and informs our
dosing regimen in our upcoming Phase 2 trial,” said Laurent
Fischer, M.D., president and chief executive officer at Adverum
Biotechnologies. “We plan to initiate the Phase 2 study in wet AMD
in the third quarter of 2022 evaluating ADVM-022 at the 2x10^11
vg/eye dose and the new, lower 6x10^10 vg/eye dose with new
enhanced prophylactic steroid regimens.”
Data Highlights
- The human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in
NHP) demonstrated potential therapeutic levels in both aqueous
humor and vitreous humor.
- Administration of the human equivalent dose of 6E10 (3 X 10^10
vg/eye dose in NHP) was well tolerated. No adverse clinical signs
were observed during the three-month study.
“We are highly encouraged by the aflibercept expression levels
and tolerability of the human equivalent dose of 6x10^10 vg/eye
supported by our data in non-human primates,” said Richard Beckman,
M.D., chief medical officer at Adverum Biotechnologies. “As we
explore doses of 2x10^11 vg/eye and lower, we are excited by the
potential of enhancing the safety profile while building on the
robust response that ADVM-022 has demonstrated to date in wet
AMD.”
Earlier this month Adverum reported data from the OPTIC trial at
The Association for Research in Vision and Ophthalmology (ARVO)
2022 Annual Meeting, assessing the potential impact of baseline
levels of neutralizing antibodies (NAbs) on efficacy and safety
outcomes with ADVM-022 (AAV.7m8-aflibercept). An encore of these
data will be featured in an oral presentation on May 19, 2022 at
ASGCT by Szilárd Kiss, M.D., Bob and Dolores Hope – Robert M.
Ellsworth, M.D. Distinguished Associate Professor in Ophthalmology
and a member of Adverum’s Scientific Advisory Board. In all
subjects, a single intravitreal injection gene therapy at the 2E11
dose demonstrated a greater than 80% reduction in annualized
anti-vascular endothelial growth factor (VEGF) injections. In
subjects with baseline NAbs <1:125, the reductions in mean
annualized injection frequency increased to 94%. Over 80% of
patients screened for the OPTIC trial had baseline NAbs titers of
<1:125. There was no correlation between baseline NAbs and
safety events.
The ADVM-022 poster and oral presentations will be made
available on the Publications page in the Pipeline section of
Adverum’s website.
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is an advanced
form of AMD, affecting approximately 10% of patients living with
AMD. Wet AMD is a leading cause of blindness in patients over 65
years of age, with a prevalence of approximately 20 million
individuals worldwide living with this condition. The incidence of
new cases of wet AMD is expected to grow significantly worldwide as
populations age. AMD is expected to impact 288 million people
worldwide by 2040, with wet AMD accounting for approximately 10% of
those cases.
About OPTIC Trial of ADVM-022 in Wet AMD
ADVM‑022 is Adverum’s clinical-stage gene therapy product
candidate being developed for the treatment of wet AMD. ADVM-022
utilizes a propriety vector capsid, AAV.7m8, carrying an
aflibercept coding sequence under the control of a proprietary
expression cassette. Unlike other ophthalmic gene therapies that
require a surgery to administer the gene therapy under the retina
(sub-retinal approach) ADVM-022 has the advantage of being
administered as a one-time IVT injection in the office and is
designed to deliver long-term efficacy and reduce the burden of
frequent anti-VEGF injections, optimize patient compliance, and
improve vision outcomes for patients with wet AMD.
The OPTIC trial is designed as a multi-center, open-label,
dose-ranging, safety and efficacy trial of ADVM-022 in patients
with wet AMD who have demonstrated responsiveness to anti-VEGF
treatment. Patients in OPTIC are treatment experienced, and
previously required frequent anti-VEGF injections to manage their
wet AMD and to maintain functional vision.
About Adverum Biotechnologies
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene
therapy company targeting unmet medical needs in serious ocular and
rare diseases. Adverum is evaluating its novel gene therapy
candidate, ADVM-022, as a one-time, intravitreal injection for the
treatment of patients with neovascular or wet age-related macular
degeneration. For more information, please visit
www.adverum.com.
Forward-looking Statements
Statements contained in this press release regarding events or
results that may occur in the future are “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include but are not limited to
statements regarding Adverum’s plans to initiate a Phase 2 study in
wet AMD in the third quarter of 2022 evaluating ADVM-022 at the 2 X
10^11 vg/eye dose and a new, lower 6 X 10^10 vg/eye dose. Actual
results could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, including risks inherent to, without limitation:
Adverum’s novel technology, which makes it difficult to predict the
timing of commencement and completion of clinical trials;
regulatory uncertainties; the results of early clinical trials not
always being predictive of future clinical trials and results; and
the potential for future complications or side effects in
connection with use of ADVM-022. Additional risks and uncertainties
facing Adverum are set forth under the caption “Risk Factors” and
elsewhere in Adverum’s Securities and Exchange Commission (SEC)
filings and reports, including Adverum’s Quarterly Report on Form
10-Q for the quarter ended March 31, 2022 filed with the SEC on May
12, 2022. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Adverum
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
Inquiries
Anand ReddiVice President, Head of Corporate Strategy and
External Affairs & EngagementAdverum Biotechnologies, Inc.T:
650-649-1358
Investors
Laurence WattsGilmartin GroupT: 619-916-7620E:
laurence@gilmartinir.com
Media
Megan TalonAssociate Director, Corporate CommunicationsAdverum
Biotechnologies, Inc.T: 650-649-1006E: mtalon@adverum.com
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