– Richard Beckman, M.D., chief medical officer, transitions to senior medical advisor –
– Star Seyedkazemi, Pharm.D., chief development officer, expands her responsibilities to lead Adverum’s clinical development, medical affairs and pharmacovigilance teams –
REDWOOD CITY, Calif., May 25, 2023 (GLOBE NEWSWIRE) — 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 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 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 AMD
Adverum 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 AMD
The 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 Biotechnologies
Adverum 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.
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 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.
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