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Sio Gene Therapies, Inc. (SIOX)

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    • Sio Gene Therapies Announces First Patient Dosed in High-Dose Cohort of AXO-AAV-GM1 Clinical Trial in Patients with GM1 Gangliosidosis
      GlobeNewswire

      Sio Gene Therapies Announces First Patient Dosed in High-Dose Cohort of AXO-AAV-GM1 Clinical Trial in Patients with GM1 Gangliosidosis

      * On-track to report topline results from low-dose cohort by end of 2020 NEW YORK and RESEARCH TRIANGLE PARK, N.C., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today announced that the first patient has been dosed in the high-dose cohort of the Phase 1/2 (“Stage 1”) study for Type I (infantile) and Type II (late infantile and juvenile onset) GM1 gangliosidosis.“AXO-AAV-GM1 is the only gene therapy in the clinic targeting patients with Type I and Type II GM1 gangliosidosis, a devastating and fatal pediatric disease,” said Gavin Corcoran, M.D., Chief R&D Officer of Sio. “The initiation of the high-dose cohort builds on evidence of extension of survival in naturally-occurring GM1 disease animal models and encouraging clinical data from an expanded access study conducted by a National Human Genome Research Institute (NHGRI) team led by our principal investigator, Dr. Cynthia Tifft at the National Institutes of Health’s (NIH) Clinical Center. Our team and academic partners are dedicated to improving the lives of children affected by this devastating disease, and we look forward to reporting topline data from the low-dose cohort before year end.”The Phase 1/2 study (NCT03952637) is designed to evaluate the safety, tolerability, and potential efficacy of AXO-AAV-GM1 delivered intravenously in patients with Type I and Type II GM1 gangliosidosis. * The low-dose cohort evaluated 1.5x1013 vg/kg AXO-AAV-GM1 gene therapy in a total of five Type II (juvenile) patients. Six-month follow-up data from the low-dose cohort are expected by the end of 2020. * The high-dose cohort is evaluating a dose of 4.5x1013 vg/kg AXO-AAV-GM1 gene therapy.AXO-AAV-GM1 has received both Orphan Drug Designation and Rare Pediatric Disease Designation and is the only gene therapy in clinical development for both Type I and Type II GM1 gangliosidosis.GM1 gangliosidosis is a progressive and fatal pediatric lysosomal storage disorder caused by mutations in the GLB1 gene that cause impaired production of the β-galactosidase enzyme. Currently, there are no approved treatment options for GM1 gangliosidosis. In 2019, Sio reported clinically meaningful improvements from baseline to six-month follow-up for the first GM1 Type II child dosed with low-dose AXO-AAV-GM1 gene therapy under an expanded access protocol.About AXO-AAV-GM1AXO-AAV-GM1 delivers a functional copy of the GLB1 gene via an adeno-associated viral (AAV) vector, with the goal of restoring β-galactosidase enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease as well. Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1’s ability to improve β-galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.About Sio Gene TherapiesSio Gene Therapies combines cutting-edge science with bold imagination to develop genetic medicines that aim to radically improve the lives of patients. Our current pipeline of clinical-stage candidates includes the first potentially curative AAV-based gene therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff diseases, which are rare and uniformly fatal pediatric conditions caused by single gene deficiencies. We are also expanding the reach of gene therapy to highly prevalent conditions such as Parkinson’s disease, which affects millions of patients globally. Led by an experienced team of gene therapy development experts, and supported by collaborations with premier academic, industry and patient advocacy organizations, Sio is focused on accelerating its candidates through clinical trials to liberate patients with debilitating diseases through the transformational power of gene therapies. For more information, visit www.siogtx.com.In 2018, Sio licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “will,” “expect,” “believe,” “estimate,” and other similar expressions are intended to identify forward-looking statements. For example, all statements Sio makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Sio’s management that, although Sio believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Sio expected. Such risks and uncertainties include, among others, the impact of the Covid-19 pandemic on our operations, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the development of a suspension-based manufacturing process for AXO-Lenti-PD; the scaling up of manufacturing, the expectations for regulatory submissions and approvals; the continued development of our gene therapy product candidates and platforms; Sio’s scientific approach and general development progress; and the availability or commercial potential of Sio’s product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Sio’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Sio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.Contacts:Media Josephine Belluardo, Ph.D. LifeSci Communications (646) 751-4361 jo@lifescicomms.com info@siogtx.comInvestors and AnalystsDavid Nassif Sio Gene Therapies Inc. Chief Financial Officer and General Counsel (646) 677-6770 investors@siogtx.com

    • Sio Gene Therapies Appoints Gene Therapy Pioneer Guangping Gao, Ph.D., as Chief AAV Scientific Advisor
      GlobeNewswire

      Sio Gene Therapies Appoints Gene Therapy Pioneer Guangping Gao, Ph.D., as Chief AAV Scientific Advisor

      * A pioneering researcher, Dr. Gao has made foundational contributions to the discovery of novel AAV vectors for gene therapy * Dr. Gao recently served as President of the American Society for Gene and Cell Therapy (ASGCT) and has been ranked as one of the top 20 translational researchers by Nature BiotechnologyNEW YORK and RESEARCH TRIANGLE PARK, N.C., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Sio Gene Therapies, Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives of patients with neurodegenerative diseases, today announced the appointment of Guangping Gao, Ph.D., as Chief AAV Scientific Advisor. Dr. Gao, a world-recognized scientist and past President of the ASGCT, has played key roles in the discovery and characterization of adeno-associated virus (AAV) serotypes which were instrumental in the resurgence of gene therapy. In his advisory role, Dr. Gao will provide strategic guidance and scientific and technical input across Sio’s AAV-based gene therapy programs.“We are honored to welcome Dr. Gao, a gene therapy pioneer, to Sio Gene Therapies,” said Pavan Cheruvu, M.D., Chief Executive Officer of Sio. “Dr. Gao brings an incredible wealth of knowledge ranging from fundamental discoveries in viral vectors, preclinical and clinical gene therapy product development, to viral manufacturing for clinical research. We believe his experience and insight will be invaluable to our team as we continue to advance our pipeline and evaluate potential business development opportunities. We look forward to collaborating with Dr. Gao as we work toward our mission of providing transformative treatments to patients with severe genetic disease.”Dr. Gao said, “Sio’s strategic approach to gene therapy directly targets the underlying disease biology, which I believe has the potential to lead to transformative and life-saving treatments. I have been impressed by the team’s comprehensive execution in driving forward clinical programs while in parallel laying a strong manufacturing foundation to support their mission to deliver these treatments to patients as rapidly as possible. I am thrilled to begin my role at Sio and look forward to leveraging my diverse experiences to fully unlock the potential of their gene therapy portfolio."Dr. Gao is Co-Director of the Li Weibo Institute for Rare Disease Research, Director of the Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems and Penelope Booth Rockwell Professor in Biomedical Research at the University of Massachusetts Medical School. Dr Gao’s more than 30 years in scientific research in molecular genetics have made foundational contributions to the development of viral vector gene therapy for rare genetic diseases including the discovery, development and engineering of novel viral vectors for in vivo gene delivery as well as preclinical and clinical gene therapy product development. He has also made significant contributions to the development of viral vector manufacturing for gene therapy applications and the development of technology platforms for novel gene therapy approaches in humans. Dr. Gao has published nearly 300 research papers and serves as the Executive Editor-In-Chief of Human Gene Therapy, Senior Editor of the Gene and Cell Therapy book series and serves on the Editorial Boards of several other gene therapy and virology journals. In addition to previously serving as President of ASGCT, he is an elected fellow of the U.S. National Academy of Inventors, holding 174 patents and an additional 373 patent applications pending with over 10 licensed to pharmaceutical companies. Dr. Gao is co-founder of Voyager Therapeutics, Adrenas Therapeutics and Aspa Therapeutics.About Sio Gene TherapiesSio Gene Therapies combines cutting-edge science with bold imagination to develop genetic medicines that aim to radically improve the lives of patients. Our current pipeline of clinical-stage candidates includes the first potentially curative AAV-based gene therapies for GM1 gangliosidosis and Tay-Sachs/Sandhoff diseases, which are rare and uniformly fatal pediatric conditions caused by single gene deficiencies. We are also expanding the reach of gene therapy to highly prevalent conditions such as Parkinson’s disease, which affects millions of patients globally. Led by an experienced team of gene therapy development experts, and supported by collaborations with premier academic, industry and patient advocacy organizations, Sio is focused on accelerating its candidates through clinical trials to liberate patients with debilitating diseases through the transformational power of gene therapies. For more information, visit www.siogtx.com.Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "will," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Sio makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Sio’s management that, although Sio believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Sio expected. Such risks and uncertainties include, among others, the impact of the Covid-19 pandemic on our operations, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the development of a suspension-based manufacturing process for Axo-Lenti-PD; the scaling up of manufacturing, the expectations for regulatory submissions and approvals; the continued development of our gene therapy product candidates and platforms; Sio’s scientific approach and general development progress; and the availability or commercial potential of Sio’s product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Sio’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 13, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Sio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.Contacts:Media and InvestorsParag Meswani Sio Gene Therapies, Inc. Chief Commercial Officer investors@siogtx.comJosephine Belluardo, Ph.D. LifeSci Communications (646) 751-4361 jo@lifescicomms.com info@siogtx.com

    • ACCESSWIRE

      SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Axovant Gene Therapies Ltd. - AXGT

      NEW YORK, NY / ACCESSWIRE / November 18, 2020 / Pomerantz LLP is investigating claims on behalf of investors of Axovant Gene Therapies Ltd.