- The stock price of Adverum Biotechnologies, Inc. (Nasdaq: ADVM) increased by over 10% pre-market today. This is why it happened.
The stock price of Adverum Biotechnologies, Inc. (Nasdaq: ADVM) – a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases – increased by over 10% pre-market today. Investors are responding positively to Adverum Biotechnologies announcing new long-term data from the OPTIC clinical trial of ADVM-022 single, in-office intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their neovascular or wet age-related macular degeneration (wet AMD). And the safety and efficacy data from patients followed through 2 years post injection are being presented at the Retina Society’s 54th Annual Scientific Meeting in Chicago, Illinois.
This is the Key Efficacy Data (July 16, 2021 cutoff date) – 2 x 10^11 vg/eye dose (n=15), planned to be evaluated in a future Phase 2 trial:
— >80% reduction in annualized anti-VEGF injection frequency in patients who previously required frequent injections
— >50% of patients (8/15) after median follow-up of 1.7 years remained entirely free of any supplemental anti-VEGF injection
— Robust aflibercept expression levels continue to be sustained through 2 years after a single injection of ADVM-022
— Vision (mean BCVA versus baseline) maintained over time
— Retinal anatomy (mean CST versus baseline) maintained to improved
This is Key Safety Data (July 16, 2021 cutoff date) – 2 x 10^11 vg/eye (n=15) and 6 x 10^11 vg/eye (n=15) doses:
— All ADVM-022-related ocular adverse events (AE) were mild (81%) to moderate (19%) across all wet AMD patients in OPTIC, and patients have reached a follow-up period of between 1 and 2 years post-treatment
a.) No dose-limiting toxicities
b.)No clinically relevant decreases in intraocular pressure
c.) No vasculitis, retinitis, choroiditis, vascular occlusions, or endophthalmitis
— At the 2 x 10^11 vg/eye dose, ocular inflammation was minimal and responsive to steroid eye drops
These are the anticipated milestones for ADVM-022:
— Plan to present INFINITY data in diabetic macular edema (DME) at the American Society of Retina Specialists’ (ASRS) 39th Annual Scientific Meeting on Saturday, October 9, 2021 at 10:28 am CT (11:28 am ET). As previously disclosed, the company is no longer planning to develop ADVM-022 in DME.
— Plan to present an encore of OPTIC data at ASRS on Monday, October 11, 2021 at 8:50 am CT (9:50 am ET)
— Plan to complete data analysis by YE21 to develop a protocol and seek investigator and regulatory feedback on a Phase 2 clinical trial in wet AMD to evaluate low doses (2 x 10^11 vg/eye and lower) of ADVM-022 and enhanced prophylaxis
— Plan to present additional long-term data from the OPTIC and OPTIC Extension studies in wet AMD
“We have now followed all wet AMD patients in the OPTIC trial for a minimum of a year, and in some cases beyond two years, after treatment with a single in-office intravitreal injection of ADVM-022. We are very pleased to report that both the promising safety profile and durability of treatment effect continue to be maintained in this patient population. We are excited to see that ADVM-022 has the potential to extend the treatment benefit from weeks to years.”
“We continue to analyze all data from patients receiving ADVM-022 in OPTIC and our INFINITY study in diabetic macular edema. We will present data from the latter on October 9 at the American Society of Retina Specialists Annual Scientific Meeting, followed by an encore presentation of OPTIC data on October 11. We look forward to completing our analysis of the data from our ADVM-022 program to meet with investigators and regulators as we outline our path forward in wet AMD. We are planning a Phase 2 trial to evaluate doses of ADVM-022 at 2 x 10^11 and lower with enhanced prophylaxis, with the goal of further improving the safety profile of ADVM-022 as we aim to deliver this novel therapy to patients.”
— Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies
“As the highest enroller in OPTIC, I have observed the potential of ADVM-022, a novel intravitreal gene therapy, to significantly reduce the treatment burden for my patients with neovascular age-related macular degeneration. In the latest data from the OPTIC trial, we have seen a manageable safety profile, robust aflibercept expression and sustained anatomical improvements 21 months after a single 2 x 10^11 dose of ADVM-022. I look forward to continuing to provide input into the future development plans for ADVM-022 in patients with neovascular AMD.”
— Arshad M. Khanani, M.D., M.A., Managing partner and Director of Clinical Research, Sierra Eye Associates; Clinical Associate Professor, University of Nevada, Reno School of Medicine and a member of Adverum’s Scientific Advisory Board
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