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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative gene therapies for chronic and debilitating diseases. The company's focus lies primarily on gene therapy solutions that address unmet medical needs, utilizing a next-generation AAV gene therapy platform developed by Professor Amit Nathwani, a leading authority in hematology from University College London (UCL).
Freeline's flagship program is FLT201, a highly differentiated gene therapy candidate targeting Gaucher disease type 1. This condition, caused by mutations in the GBA1 gene, leads to a deficiency in the glucocerebrosidase (GCase) enzyme, resulting in harmful substrate accumulation in organs such as the spleen, liver, bone, and lungs. FLT201 employs a rationally engineered longer-acting GCase variant designed to produce sustained enzyme levels and penetrate deeper tissues, potentially halting disease progression and improving patient outcomes with a single treatment. Early clinical data from the GALILEO-1 trial highlight the therapy’s potential, showing substantial reductions in key biomarkers and robust increases in plasma GCase activity.
Building on its work in Gaucher disease, Freeline has initiated a research program targeting GBA1-linked Parkinson’s disease. This program aims to extend the therapeutic benefits of its engineered GCase variant to patients suffering from Parkinson's disease due to GBA1 mutations. These mutations significantly increase the risk of Parkinson’s disease, leading to earlier onset, more severe symptoms, and faster progression to dementia. The preclinical data for this program is promising, showcasing the gene therapy’s enhanced enzyme activity in various cell lines.
Headquartered in the UK, with operations in the United States, Freeline is driven by its commitment to employing innovative gene therapy techniques to provide life-changing treatments. The company leverages proprietary AAVS3 capsid technology and novel promoters and transgenes to deliver functional copies of therapeutic genes to liver cells, ensuring persistent and effective protein expression. Freeline’s pipeline promises significant advancements, with FLT201 leading the charge in ongoing clinical trials and additional programs in the research phase.
Freeline's recent achievements and financial updates reflect its proactive stance in advancing its mission. The company’s financial results for the second quarter of 2023 reveal significant progress and a solid strategic focus, emphasizing the advancement of FLT201 as its top priority. The successful dosing of patients in the GALILEO-1 trial and the unveiling of the GBA1-linked Parkinson’s disease program underline Freeline's relentless pursuit of innovative treatments for genetic disorders.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced its participation in two virtual investor conferences. The first, Guggenheim Healthcare Talks: 2021 Genomic Medicines and Rare Disease, is on April 1, 2021, featuring CEO Theresa Heggie discussing gene therapy challenges at 10:00 a.m. EDT. The second is the 20th Annual Needham Virtual Healthcare Conference on April 13, 2021, where Heggie will present a Company overview at 8:00 a.m. EDT. Webcasts of both events will be available on the Freeline investor relations website.
Freeline Therapeutics announced the appointment of Colin A. Love, PhD, to its Board of Directors, effective immediately. Dr. Love brings over 30 years of experience in the biopharmaceutical sector, including significant contributions at Amgen and BioVex. His expertise comes at a pivotal moment for Freeline as it advances towards the potential commercialization of its gene therapy pipeline. The company focuses on treating debilitating inherited diseases through innovative gene therapies, aiming to deliver long-term cures with single-dose treatments.
LONDON, March 2, 2021 (GLOBE NEWSWIRE) -- Freeline Therapeutics (Nasdaq: FRLN) announced that CEO Theresa Heggie will present at two virtual investor conferences in March. The presentations will take place at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, and the Barclays Global Healthcare Conference on March 10, 2021. Both presentations will be available on-demand on the Freeline website. The company, focused on gene therapies for inherited systemic diseases, has ongoing clinical programs for Hemophilia B and Fabry disease.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the appointment of Michael J. Parini as President and Chief Operating Officer, effective March 15, 2021, as part of an executive leadership expansion. This follows the recent hiring of Stephen P. Diamond as General Counsel and David S. Arrington as Vice President of Investor Relations. Meanwhile, Brian M. Silver, the current CFO, will leave Freeline on April 30, 2021, to pursue new opportunities. The company is now searching for his replacement, aiming to enhance its operational and strategic functions to drive growth in gene therapy development.
Freeline Therapeutics (Nasdaq: FRLN) announced data demonstrating the potential of FLT201 for treating Gaucher disease, focusing on delivering β-glucocerebrosidase variant 85 effectively to target tissues inadequately addressed by existing enzyme replacement therapies. The company plans to begin first-in-human dose finding studies for FLT201 in late 2021. Highlights from recent presentations show FLT201's enhanced tissue penetration and efficacy, which could lead to improved patient outcomes. The proprietary AAVS3 capsid technology supports a 20-fold increase in GCase potency, aiming for substantial clinical advances.
Freeline Therapeutics announced a revision to its FLT180a program for Hemophilia B, responding to FDA feedback on the comparability of investigational drug products. A new Phase 1/2 dose confirmation trial is planned to begin by the end of 2021, with results expected by the end of 2022. The Phase 3 pivotal trial is targeted for mid-2023, aiming for a BLA submission by the end of 2024. The trial will assess the dose's safety and efficacy, using data from prior studies to guide dose selection.
Freeline Therapeutics (Nasdaq: FRLN) announced it will present at the 2021 EAHAD Virtual Congress on February 2, including two e-posters and one oral presentation about its AAV gene therapy for hemophilia and Gaucher disease. Key presentations include a study on FLT180a for severe Hemophilia B and insights from the CHESS II study. Additionally, at the WORLD Symposium on February 11, the company will present data on FLT201 targeting Type 1 Gaucher Disease. Presentations will be available online via the Freeline website post-event.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced its participation in two virtual conferences in January 2021, focusing on advancing gene therapy for patients with inherited systemic diseases. On January 8, CEO Theresa Heggie will join a panel at the LifeSci Partners 10th Annual Healthcare Corporate Access Event. On January 13, she will present at the 39th Annual J.P. Morgan Healthcare Conference, followed by virtual one-on-one meetings. Interested parties can access live webcasts on the company's investor relations website.
Freeline Therapeutics (Nasdaq: FRLN) announced promising updates from its Phase 1/2 B-AMAZE trial of FLT180a for severe hemophilia B, showing durable Factor IX (FIX) activity lasting nearly three years with no bleeds needing FIX supplementation. The company successfully concluded an End of Phase 2 meeting with the FDA and plans to start a pivotal Phase 2b/3 trial in H2 2021. Key findings include a tailored immune management strategy and dose selection aimed at achieving normal FIX levels in patients. This development marks progress towards providing functional cures for hemophilia B.
Freeline Therapeutics (Nasdaq: FRLN) announced management's participation in a fireside chat at the 3rd Annual Evercore ISI Health CONx Conference on December 3, 2020, from 08:00 to 08:20 am ET. The event will feature a live audio webcast available on Freeline's website, with a recording accessible for 90 days post-conference. Freeline specializes in systemic AAV-based gene therapy for chronic diseases, aiming to improve patient lives through potential one-time functional cures.
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