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Axovant Gene Therapies Ltd. will rebrand as Sio Gene Therapies, Inc., effective November 13, 2020, with a new ticker symbol SIOX on NASDAQ. This change represents the company's shift towards a focus on developing disease-modifying and curative genetic medicines. The CEO emphasized the company's transformation and its commitment to innovative gene therapy solutions for severe conditions, including Parkinson's disease. The company is also undergoing a redomiciliation from Bermuda to Delaware and will have a majority independent Board of Directors. Stockholder actions are not required.
Axovant Gene Therapies has received FDA IND clearance for AXO-AAV-GM2, the first investigational gene therapy targeting Tay-Sachs and Sandhoff diseases. This marks Axovant's second IND clearance within a year, emphasizing its commitment to advancing gene therapies for neurodegenerative conditions. The clinical study will enroll both infantile and juvenile subjects, assessing the safety and efficacy of the therapy. Previous studies indicated positive outcomes, and the company aims to collaborate with leading research organizations to expedite development.
Axovant Gene Therapies (Nasdaq: AXGT) released updates for its AXO-Lenti-PD gene therapy targeting Parkinson’s disease during a virtual R&D Day on October 30, 2020. The second cohort of the SUNRISE-PD study showed promising patient-level data, emphasizing improved safety, tolerability, and clinical outcomes among participants. However, delays in the manufacturing process could postpone patient enrollment in the upcoming randomized study. The company aims to provide further program timeline updates in early 2021.
Axovant Gene Therapies Ltd. (Nasdaq: AXGT) will host a virtual R&D Day on October 30, 2020, at 11:30 AM ET, to discuss its AXO-Lenti-PD gene therapy for Parkinson’s disease. The event will feature presentations from clinical researchers and the Michael J. Fox Foundation, focusing on treatment landscapes and unmet needs in Parkinson’s disease. Data from the Phase 2 SUNRISE-PD study's second cohort will be presented, including individual patient-level data at 6 months post-dosing. AXO-Lenti-PD aims to improve motor function by delivering critical enzymes for dopamine synthesis.
Axovant Gene Therapies Ltd. (NASDAQ: AXGT) has received Rare Pediatric Disease Designation from the FDA for its gene therapy AXO-AAV-GM2, aimed at treating GM2 gangliosidosis (Tay-Sachs and Sandhoff disease). This therapy, which can potentially be the first approved treatment for these currently untreatable conditions, has already shown promise in two patients with infantile Tay-Sachs. Axovant plans to initiate a registrational clinical trial to further evaluate AXO-AAV-GM2. The FDA recognizes rare pediatric diseases as serious conditions affecting under 200,000 individuals in the U.S.
Axovant Gene Therapies Ltd. (AXGT) received Rare Pediatric Disease Designation from the FDA for its gene therapy AXO-AAV-GM1, targeting GM1 gangliosidosis. This AAV9-based therapy offers a single intravenous administration and is currently in Phase 1/2 trials. It holds both Rare Pediatric and Orphan Drug designations, emphasizing its potential in treating a fatal pediatric disease with no existing treatment options. Axovant anticipates reporting 6-month data from the juvenile cohort by Q4 2020 and plans to start a high-dose cohort study in the latter half of 2020.
Axovant Gene Therapies Ltd. (NASDAQ: AXGT) appoints Dr. Kristiina Vuori as a Board member and promotes Parag V. Meswani to Chief Commercial Officer (CCO). Dr. Vuori is known for her leadership in genetics and cancer research at the Sanford Burnham Prebys Medical Discovery Institute. Her appointment strengthens the Board's independence and diversity. Meswani's promotion underscores his commercial expertise, aiming to enhance Axovant's pipeline of gene therapies for neurological diseases. Both changes are positioned to support the company's growth and upcoming clinical advancements.
Axovant Gene Therapies Ltd. (NASDAQ: AXGT) announced positive six-month follow-up results from the SUNRISE-PD Phase 2 trial of AXO-Lenti-PD for Parkinson’s disease. The therapy was well-tolerated with no serious adverse effects. Notably, patients experienced a 21-point mean improvement in the UPDRS Part III 'OFF' score, exceeding predefined success criteria. Improvements were also observed in 'good ON' and 'OFF' diary assessments, with over 2-hour enhancements. The company plans to initiate a randomized sham-controlled study, EXPLORE-PD, in 2021, focusing on continued development and evaluation of safety.
Axovant Gene Therapies Ltd. (Nasdaq: AXGT) announced the presentation of six-month safety and efficacy data from its AXO-Lenti-PD program on October 6, 2020. This follows their participation in the Chardan 4th Annual Genetic Medicines Conference, and a panel at the 2020 ARM Virtual Cell and Gene Meeting scheduled for October 13, 2020. Additionally, Axovant will host a Parkinson’s Disease R&D Day on October 30, 2020, aimed at discussing significant advancements in gene therapies for neurodegenerative diseases.
Axovant Gene Therapies (NASDAQ: AXGT) has partnered with Viralgen to enhance the development and commercialization of its AAV gene therapies for GM1 and GM2 gangliosidosis. This collaboration enables access to cGMP manufacturing capabilities, bolstering clinical and commercial prospects. The partnership is expected to expedite the production process, with ongoing trials and anticipated regulatory submissions for AXO-AAV-GM1 and AXO-AAV-GM2. The agreement highlights the urgency in addressing these critical pediatric diseases lacking treatment options.
