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Generation Bio Co. (Nasdaq: GBIO) is a pioneering biotechnology company dedicated to developing innovative genetic medicines to treat rare and prevalent diseases. The company's mission is to deliver durable and redosable treatments through their groundbreaking platforms. Generation Bio focuses on liver and retina-related diseases and has built a robust pipeline leveraging two main proprietary technologies: the cell-targeted lipid nanoparticle (ctLNP) delivery system and immune-quiet DNA (iqDNA) cargo.
Using the ctLNP delivery system, Generation Bio can selectively target specific tissues and cell types, significantly reducing off-target effects. This system has shown promising results in both mouse models and non-human primates (NHPs), demonstrating effective delivery of genetic materials with minimal immunogenic response. The ctLNP platform is a cornerstone of their collaborative efforts with Moderna, aimed at developing highly specific in vivo delivery systems for T cells and other immune cells.
iqDNA, an optimized variant of the company's closed-ended DNA (ceDNA), stands out for its ability to evade the immune system while maintaining high levels of gene expression. This feature addresses a critical challenge in genetic therapies by allowing for repeated dosing without triggering adverse immune responses. Recent studies have shown that iqDNA has a tolerability profile comparable to chemically modified messenger RNA (mRNA) in both mice and NHPs.
Generation Bio's commitment to innovation is further highlighted by their rapid enzymatic synthesis (RES) manufacturing process. This proprietary method enables scalable and efficient production of their novel DNA constructs, ensuring high purity and consistency. The company believes that RES can support the manufacturing scale required to meet global clinical and commercial demands.
Recent announcements have emphasized the company's progress and strategic collaborations. For instance, their partnership with Moderna focuses on leveraging ctLNPs for targeted delivery of nucleic acid therapies to specific immune cell types. Additionally, Generation Bio's sustained financial health, supported by careful expense management and collaboration incomes, ensures a steady runway into 2026, enabling continued investment in their groundbreaking technologies.
On the business front, Generation Bio is ramping up efforts across their platforms, with ongoing programs targeting hemophilia A, sickle cell disease, and beta-thalassemia. The company is actively presenting their latest data at key industry conferences like the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, showcasing the advanced capabilities of their ctLNP and iqDNA platforms.
For more information about Generation Bio’s revolutionary work in genetic medicine, please visit their website at www.generationbio.com or follow their updates on Twitter (@lifetimegenetx).
Generation Bio Co. (Nasdaq: GBIO) announced that its CEO, Geoff McDonough, will participate in the Gene Therapy panel at the 42nd Annual Cowen Health Care Conference on March 9 at 12:50 p.m. ET. A live webcast will be available on the investor section of the company's website, with a replay accessible for 30 days following the event.
The company is focused on innovative genetic medicines aimed at providing durable treatments for rare and prevalent diseases, utilizing its proprietary non-viral genetic medicine platform.
Generation Bio Co (Nasdaq: GBIO) reported a cash position of $375.1 million at the end of 2021, expected to fund operations through 2024. The company is focused on advancing its genetic medicine platform, targeting liver diseases and retinal conditions. In 2021, R&D expenses rose to $85.2 million from $58.5 million in 2020. The net loss for 2021 was $119.2 million, a decrease in loss per share from $2.95 to $2.12. The company aims to optimize its delivery systems for ongoing hemophilia A and Stargardt disease programs.
Generation Bio Co. (Nasdaq: GBIO) announced the promotion of Antoinette Paone to chief operating officer (COO). Having previously served as senior vice president and head of regulatory affairs since 2018, she brings over 20 years of experience in the pharmaceutical and biotech sectors. Paone will oversee the company's good manufacturing practice (GMP) capabilities, vital for developing its unique genetic medicine platform, which includes closed-ended DNA constructs and a lipid nanoparticle delivery system. This strategic move is aimed at enhancing operational efficiency and supporting the company's mission to deliver innovative treatments.
Generation Bio Co. (Nasdaq: GBIO) announced its participation in the virtual 40th Annual J.P. Morgan Healthcare Conference, scheduled for January 12, 2022, from 8:15-8:55 a.m. ET. A live webcast of the presentation and Q&A will be accessible on the company's investor website, with a replay available for 30 days post-event. Generation Bio focuses on innovative genetic medicines aimed at treating rare and prevalent diseases, utilizing a novel delivery system and scalable manufacturing process to enhance treatment durability and efficiency.
Generation Bio (Nasdaq: GBIO) reported significant advancements in its genetic medicine platform for treating hemophilia A, demonstrating up to 205% normal human factor VIII expression in mouse studies using its closed-ended DNA (ceDNA) and cell-targeted lipid nanoparticle (ctLNP) technology. Non-human primate studies showed up to 2% factor VIII expression, with noted variability. The company plans to enhance species translation for further development. Upcoming updates and timing for its first IND submission are expected in 2022.
Generation Bio Co (Nasdaq: GBIO) reported promising preclinical data at the ESGCT Annual Virtual Congress, showcasing the efficacy of their cell-targeted lipid nanoparticle (ctLNP) delivery platform for retinal therapies. The data indicated broad delivery and durable expression of closed-ended DNA (ceDNA) comparable to AAV5, suggesting potential for gene editing in retinal diseases. Financially, they reported a net loss of $31.9 million for Q3 2021, an increase from $20.8 million in Q3 2020, with R&D expenses rising to $22 million. Cash reserves improved to $398.4 million as of September 30, 2021.
Generation Bio Co (Nasdaq: GBIO) presented new preclinical data at the ESGCT 2021 Annual Virtual Congress, demonstrating effective sub-retinal delivery of closed-ended DNA (ceDNA) using its cell-targeted lipid nanoparticle (ctLNP). The study shows broad photoreceptor distribution and durable expression with ctLNP in rodents, comparable to AAV5. Additionally, ctLNP mRNA delivery in non-human primates indicates potential as a leading non-viral method for gene editing in the retina. This platform aims to address inherited retinal diseases and expand opportunities for gene therapy.
Generation Bio Co. (Nasdaq: GBIO), a leader in genetic medicines for rare and prevalent diseases, announced that its CEO, Geoff McDonough, will participate in a fireside chat at the Jefferies Virtual Gene Therapy/Editing Summit on October 27 at 5:00 p.m. ET. A live webcast will be available on the company's investor website, with a replay accessible for 30 days after the event. The company focuses on innovative genetic therapies through its proprietary non-viral platform, which aims to provide durable treatments and scalable manufacturing for more patients globally.
On October 15, 2021, Generation Bio (Nasdaq: GBIO) announced an upcoming oral presentation at the European Society of Gene and Cell Therapy Annual Virtual Congress, scheduled for October 19-22. The presentation will showcase preclinical advancements in retinal therapies using a novel lipid nanoparticle for broad cellular delivery. Matthew Stanton, Ph.D., emphasized the potential of their non-viral delivery system to address challenges faced by viral gene therapies. Attendees can access the presentation online on October 22 and a recorded version for 30 days afterward.
Generation Bio (Nasdaq: GBIO) reported its second-quarter 2021 financial results, showcasing a cash position of $425.2 million as of June 30, 2021, a notable increase from $262.3 million at the end of 2020. R&D expenses rose to $22.7 million, up from $13.5 million year-over-year. The net loss expanded to $30.8 million, or $0.55 per share, compared to a net loss of $17.7 million or $1.50 per share last year. The company is transitioning to a new manufacturing process and has signed a lease for a 104,000 square feet cGMP facility in Waltham, expected to be operational in 2023.
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