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Adverum (ADVM) Doses First Patient in the Mid-Stage wAMD Study

Adverum Biotechnologies, Inc. ADVM announced that the first patient was dosed in the phase II LUNA study evaluating its lead product candidate ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD). Shares of this clinical-stage entity were up 2.83% on Sep 14.

Ixoberogene soroparvovec (Ixo-vec) is Adverum’s clinical-stage gene therapy product candidate, currently being developed 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.

While most ophthalmic gene therapies require surgery to administer the gene therapy under the retina (sub-retinal approach), Ixo-vec is designed to be administered as a one-time intravitreal (IVT) injection to 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.

LUNA trial is a multicenter, double-masked, randomized, parallel-group study evaluating two doses of Ixo-vec, including the 2x10^11 vg/eye dose and a new, lower 6x10^10 vg/eye dose for wet AMD. The study will enroll 72 participants equally across two doses and four prophylactic steroid regimens in approximately 40 sites in the United States and Europe.

Specific regimens being evaluated include topical Durezol (difluprednate), IVT Ozurdex (dexamethasone) or a combination of either topical Durezol or IVT Ozurdex with oral prednisone to establish a prophylactic regimen with minimal need for inflammation management post prophylaxis.

Per management, LUNA will explore a new, lower 6E10 dose will reinforce the robust, durable efficacy and safety profile already demonstrated with the 2E11 dose in the OPTIC study.

The primary endpoints include the mean change in best corrected visual acuity (BCVA) from baseline to one year, and the incidence and severity of adverse events. Key secondary objectives include the mean change in central subfield thickness (CST) from baseline to one year and assessment of the effectiveness of prophylactic steroid regimens on minimizing inflammation.

Additionally, LUNA will assess aflibercept protein expression starting at week 10 and include an interim analysis at week 26. The study participants will also have the option to enroll in a long-term extension study. Interim data is anticipated in 2023.

The stock has declined 38.1% so far this year compared with the industry’s decrease of 23.1%.

 

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The successful development of the candidate will significantly boost this clinical-stage player, considering the potential of Ixo-vec to meaningfully reduce the treatment burden of frequent anti-VEGF injections for wet AMD patients.

The FDA granted Ixo-vec a Fast Track designation to treat wet AMD. In June 2022, the European Medicines Agency (EMA) granted ADVM-022 a Priority Medicines (PRIME) status for wet AMD.

Aflibercept is the active lead component in Regeneron’s REGN Eylea to treat wet AMD. Aflibercept injection 2mg is approved under the brand name Eylea for treating patients with wAMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). Eylea is one of the leading drugs for wAMD.

Regeneron has a collaboration agreement with Bayer AG BAYRY for Eylea. While Regeneron records net product sales of Eylea in the United States, Bayer records net product sales of the drug outside the United States. REGN records its share of profits/losses in connection with the sales of Eylea outside the United States.

Adverum currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Dynavax DVAX, which carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.


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