Welcome to our dedicated page for Freeline Therapeutics Holdings Plc news (Ticker: FRLN), a resource for investors and traders seeking the latest updates and insights on Freeline Therapeutics Holdings Plc stock.
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 (Nasdaq: FRLN) announced the dosing of the first patient in its Phase 1/2 B-LIEVE trial for FLT180a, a gene therapy targeting hemophilia B. The trial aims to confirm the optimal dose and restore normal clotting factor IX levels. Optimistically, the CMO stated that a low dose combined with a short immune management regimen could sustain normal FIX expression. Initial safety and biomarker data are expected by mid-2022, with plans for a Phase 3 trial startup in the first half of 2023.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced on February 28, 2022, the grant of 165,700 non-statutory options to three newly hired employees, in alignment with Nasdaq Listing Rule 5635(c)(4). The options, with an exercise price of $1.09 per share, were approved by an independent subcommittee and are part of the 2021 Equity Inducement Plan. They will vest over four years, with 25% vesting after one year. Freeline specializes in AAV vector-mediated gene therapies for inherited diseases, with ongoing clinical programs in Hemophilia B, Fabry disease, and Gaucher disease Type 1.
Freeline Therapeutics (Nasdaq: FRLN) announced promising early results from its Phase 1/2 MARVEL-1 trial for FLT190, a gene therapy for Fabry disease, showing well-tolerated treatment with sustained α-Gal A expression for up to two years. Additionally, the company initiated the GALILEO-1 trial to assess FLT201's safety and efficacy in Gaucher disease Type 1. FLT201 incorporates a novel glucocerebrosidase variant and aims to provide a one-time treatment solution. Both trials leverage Freeline's proprietary AAVS3 capsid technology.
Freeline Therapeutics (Nasdaq: FRLN) announced on January 31, 2022, the grant of non-statutory options to three newly hired employees, totaling 66,400 ordinary shares. These options are part of the 2021 Equity Inducement Plan and were approved by an independent subcommittee of the remuneration committee. Each option has an exercise price of $1.18 per share and will vest over four years, with 25% vesting after the first year. Freeline focuses on AAV-mediated gene therapies targeting inherited systemic diseases.
Freeline Therapeutics Holdings plc announced the appointment of Henning R. Stennicke as Chief Scientific Officer effective March 1, 2022. With 26 years of experience, including 20 years at Novo Nordisk, Stennicke will lead the company's research and platform technology advancements. CEO Michael Parini expressed enthusiasm about Stennicke's potential to drive scientific strategies to meet patient needs. The transition follows interim leadership by Professor Amit Nathwani and will involve close collaboration with Head of Research, Rose Sheridan.
AVROBIO (Nasdaq: AVRO), a clinical-stage gene therapy company, has appointed Sean O’Bryan as its new Chief Regulatory Officer. O’Bryan brings over 30 years of regulatory experience in the biotech sector, most recently at Freeline Therapeutics. His appointment is expected to enhance AVROBIO's clinical programs, particularly in lysosomal disorders such as cystinosis and Gaucher disease. CEO Geoff MacKay expressed confidence in O’Bryan's expertise to accelerate AVROBIO's mission of delivering personalized gene therapies.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced its participation in the 18th Annual WORLD Symposium™ on lysosomal storage diseases, taking place from February 7-11, 2022, in San Diego, California.
The company will present updated data from the Phase 1/2 MARVEL-1 clinical trial for FLT190, targeting Fabry disease, and detail the GALILEO-1 design, assessing FLT201 for Gaucher disease Type 1.
Presentations will be delivered by Derralynn A. Hughes, with a platform presentation on February 11 and poster presentations on February 8 and 9.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the grant of non-statutory options to purchase 89,200 ordinary shares to four newly hired employees as of December 31, 2021. This grant, approved by an independent subcommittee, aims to incentivize new talent in line with Nasdaq Listing Rule 5635(c)(4). Each option has an exercise price of $2.00 per share, equivalent to the closing price on December 30, 2021, and vests over four years, with the first 25% vesting after one year. Freeline specializes in AAV-mediated gene therapies for inherited systemic diseases.
Freeline Therapeutics (Nasdaq: FRLN) announced the FDA's clearance of its IND application for FLT201, marking it as the first AAV gene therapy for Gaucher disease Type 1 to enter clinical trials. The Phase 1/2 trial is set to begin patient dosing in H1 2022, with initial safety data expected by Q3 2022. FLT201 aims to provide a one-time transformative treatment, potentially reducing the need for enzyme replacement therapy. The unique AAVS3 capsid technology targets hard-to-treat tissues, offering hope for significant patient benefit.
On January 4, 2022, Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced that CEO Michael Parini will present at two virtual conferences. The first is the H.C. Wainwright BioConnect Conference on January 10, 2022, with an on-demand webcast available at 7:00 a.m. EST. The second is the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, featuring a live audio webcast at 10:30 a.m. EST. Freeline specializes in AAV-mediated gene therapies for inherited diseases, with ongoing clinical programs in hemophilia B, Fabry disease, and Gaucher disease Type 1.