Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage
company that aims to establish gene therapy as a new standard of
care for highly prevalent ocular diseases, today announced new
executive leadership roles that support the ongoing development of
the investigational gene therapy ixoberogene soroparvovec
(Ixo-vec). Ixo-vec is currently being evaluated in the Phase 2 LUNA
trial as a one-time intravitreal (IVT) injection for patients in
the treatment of neovascular or wet age-related macular
degeneration (wet AMD).
On June 1, 2023, Richard Beckman, M.D., will transition to the
new role of senior medical advisor. Dr. Beckman will continue to
advise on Adverum’s pipeline, including Ixo-vec, and support our
external engagement with key stakeholders. Star Seyedkazemi,
Pharm.D., chief development officer, is expanding her
responsibilities to lead Adverum’s clinical development, medical
affairs and pharmacovigilance teams. Dr. Seyedkazemi brings
extensive experience in clinical development and medical affairs
from Tobira, Allergan, Gilead Sciences and Johnson & Johnson.
Dr. Seyedkazemi will be supported by Kali Stasi, M.D., Ph.D.,
senior vice president of clinical development. Dr. Stasi brings
over 20 years of experience in both ophthalmology and drug
development, specializing in retinal gene and cell therapies. She
was previously at Novartis Institute for Biomedical Research and
Tenpoint Therapeutics. Dr. Beckman and Dr.
Seyedkazemi will continue to report to Laurent Fischer, M.D.,
president and chief executive officer of Adverum
Biotechnologies.
“On behalf of Adverum and our Board of Directors, I’d like to
thank Rick for his important contributions to Adverum in advancing
Ixo-vec in the clinic and building out the clinical development and
pharmacovigilance teams,” commented Dr. Fischer. “I am pleased that
he will continue to work with Adverum in his role as senior medical
advisor. Over the last year, Adverum has made tremendous progress,
including the successful launch of our LUNA trial and outstanding
progress in the global development strategy for Ixo-vec, including
attaining of PRIME designation from the European Medicines Agency
and the Innovation Passport from the United Kingdom’s Medicines and
Healthcare Products Regulatory Agency.”
“Throughout my career, I have wanted to advance transformational
medicines with the potential to improve the practice of
ophthalmology and bring tangible benefits to patients,” stated
Richard Beckman, M.D., chief medical officer of Adverum
Biotechnologies. “The Phase 2 LUNA trial brings us a step closer to
our mission of establishing gene therapy as a new standard of care
for wet AMD. I look forward to my continued work with Laurent, Star
and the team.”
Anticipated LUNA 2023 Milestones
- 2H 2023 – Anticipate full enrollment of the
Phase 2 LUNA trial
- Q3 2023 – Anticipate LUNA 14-week data,
including aflibercept protein levels for a percentage of the
cohort
- Q4 2023 – Anticipate LUNA preliminary efficacy
and safety data
About Wet Age-Related Macular DegenerationWet
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 people over 65 years of age,
with approximately 20 million individuals worldwide living with
this condition. New cases of wet AMD are 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. Additionally, wet
AMD is a bilateral disease and incidence of nAMD in the second eye
is up to 42% in the first two to three years.
About Ixo-vec in Wet AMDAdverum is developing
ixoberogene soroparvovec (Ixo-vec, formerly referred to as
ADVM-022), its clinical-stage gene therapy product candidate, for
the treatment of wet AMD. Ixo-vec utilizes a proprietary vector
capsid, AAV.7m8, carrying an aflibercept coding sequence under the
control of a proprietary expression cassette. Unlike other
ophthalmic gene therapies that require surgery to administer the
gene therapy under the retina (sub-retinal approach), Ixo-vec is
designed to be administered as a one-time IVT injection in the
physician’s office, deliver long-term efficacy, reduce the burden
of frequent anti-vascular endothelial growth factor (VEGF)
injections, optimize patient compliance and improve vision outcomes
for patients with wet AMD. In recognition of the need for new
treatment options for wet AMD, the U.S. Food and Drug
Administration granted Fast Track designation for Ixo-vec for the
treatment of wet AMD. Ixo-vec also received PRIME designation from
the European Medicines Agency and the Innovation Passport from the
United Kingdom’s Medicines and Healthcare Products Regulatory
Agency for the treatment of wet AMD.
About LUNA Trial of Ixo-vec in Wet AMDThe LUNA
trial is a double-masked, randomized, Phase 2 trial being conducted
at approximately 40 sites in the U.S. and Europe. LUNA will
evaluate Ixo-vec in subjects with wet AMD who are 50 years or older
and have demonstrated a response to anti-VEGF treatment. Up to 72
subjects will be randomized equally between the previously
evaluated 2E11 vg/eye dose and a new, lower 6E10 vg/eye dose. Four
prophylactic corticosteroid regimens will be studied with the aim
of establishing a prophylactic corticosteroid regimen with minimal
need for inflammation management post prophylaxis. Prophylactic
regimens being evaluated include 22 weeks of a tapered regimen of
topical difluprednate (Durezol®), a single administration of IVT
dexamethasone (Ozurdex®), and a combination of either topical
Durezol® or IVT Ozurdex® with up to 10 weeks of a tapered regimen
of oral prednisone. All four prophylactic corticosteroid regimens
in LUNA cover the period of peak immunogenicity observed in
non-clinical studies and in the Phase 1 OPTIC study.
The LUNA trial primary endpoints are mean change in best
corrected visual acuity (BCVA) from baseline to one year, as well
as the incidence and severity of adverse events. Important
secondary endpoints in LUNA include the mean change in central
subfield thickness (CST) from baseline to one year and assessing
the effectiveness of prophylactic corticosteroid regimens on
minimizing inflammation. Additionally, LUNA will assess aflibercept
protein levels starting at Week 14 and include an interim analysis
at Week 26. Study participants will have the option to enroll in a
long-term extension study.
About Adverum BiotechnologiesAdverum
Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that
aims to establish gene therapy as a new standard of care for highly
prevalent ocular diseases with the aspiration of developing
functional cures to restore vision and prevent blindness.
Leveraging the capabilities of its proprietary intravitreal (IVT)
platform, Adverum is developing durable, single-administration
therapies, designed to be delivered in physicians’ offices, to
eliminate the need for frequent ocular injections to treat these
diseases. Adverum is evaluating its novel gene therapy candidate,
ixoberogene soroparvovec (Ixo-vec, formerly referred to as
ADVM-022), as a one-time, IVT injection for patients with
neovascular or wet age-related macular degeneration. By overcoming
the challenges associated with current treatment paradigms for
debilitating ocular diseases, Adverum aspires to transform the
standard of care, preserve vision, and create a profound societal
impact around the globe. For more information, please visit
www.adverum.com.
Forward-looking StatementsStatements 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 the
potential benefits of Ixo-vec in the treatment of wet AMD, the
design of and enrollment in the LUNA trial, including the
prophylactic corticosteroid regimens, and anticipated interim data
from the LUNA trial. 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; enrollment
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 Ixo-vec. 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, 2023 filed with the SEC on May
11, 2023. 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.
Corporate, Investor and Media InquiriesAnand
ReddiVice President, Head of Corporate Strategy, External Affairs
and EngagementAdverum Biotechnologies, Inc.T: 650-649-1358E:
areddi@adverum.com
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