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Intellia Therapeutics, Inc. reports clinical, regulatory and financing developments as a clinical-stage biopharmaceutical company using CRISPR gene editing and other core technologies. Its recurring updates center on in vivo and ex vivo therapeutic approaches for genetically defined diseases, including lonvoguran ziclumeran, or lonvo-z, for hereditary angioedema and nexiguran ziclumeran, or nex-z, for ATTR amyloidosis with cardiomyopathy and polyneuropathy.
Company announcements also cover Phase 3 clinical data, FDA interactions, biologics license application activity, quarterly financial results, common stock offerings, equity incentive grants and investor conference participation. These updates reflect Intellia's progress from gene-editing research and clinical development toward regulatory and commercial planning for its lead programs.
Intellia Therapeutics (NASDAQ:NTLA) announced upcoming presentations at two investor conferences in October 2022. The Chardan’s 6th Annual Genetic Medicines Conference is scheduled for October 3, 2022, at 8:30 a.m. ET in a fireside chat format. The 2022 Truist Securities Genetic Medicine Summit will include a genome editing panel on October 20, 2022, at 9:00 a.m. ET. A live webcast of the Chardan presentation will be available on Intellia's website, with a replay accessible for 30 days.
Intellia Therapeutics announced promising interim results from the Phase 1 study of NTLA-2001, a CRISPR/Cas9 therapy for transthyretin (ATTR) amyloidosis. At doses of 0.7 mg/kg and 1.0 mg/kg, mean serum transthyretin (TTR) reductions of 93% and 92% were observed at day 28. The treatment was well-tolerated, with transitory infusion reactions as the only adverse events. These outcomes suggest NTLA-2001 may provide a single-dose treatment option for patients with cardiomyopathy manifestations of ATTR amyloidosis. Further discussions on this data are scheduled for an investor event today.
Intellia Therapeutics and Regeneron Pharmaceuticals announced promising interim results from the Phase 1 study of NTLA-2001, a CRISPR therapy for transthyretin (ATTR) amyloidosis. The trial exhibited significant mean serum transthyretin reductions of 93% and 92% at doses of 0.7 mg/kg and 1.0 mg/kg, respectively, on day 28. The treatment was well-tolerated, with minimal adverse reactions. Follow-ups indicated sustained reductions over two to six months. Intellia plans to expand the study with a fixed dose of 0.7 mg/kg and aims for a pivotal trial, potentially including U.S. patients.
Intellia Therapeutics (NASDAQ:NTLA) announced positive interim results from its Phase 1/2 study of NTLA-2002, a CRISPR-based treatment for hereditary angioedema (HAE). A single dose of 25 mg resulted in a 91% reduction in HAE attacks over 16 weeks, with two patients remaining attack-free. At 75 mg, the treatment achieved a 92% reduction in plasma kallikrein levels. NTLA-2002 was well-tolerated, with mild adverse events. The company plans to proceed with a Phase 2 dose-expansion in H1 2023. These findings validate Intellia's genome editing platform, highlighting its potential to address various genetic diseases.
SparingVision, a French biotech focused on genomics in ophthalmology, has secured Series B financing co-led by Jeito Capital and the University of Pittsburgh Medical Center Enterprise. The $XX million funding will accelerate development of its lead treatments, SPVN06 and SPVN20, targeting retinitis pigmentosa. The investment supports first-in-human studies and further innovations in their pipeline. SparingVision aims to bring mutation-agnostic genomic therapies to patients suffering from inherited retinal diseases and dry age-related macular degeneration.
Intellia Therapeutics announced a virtual investor event on September 16, 2022, to present interim data from its ongoing Phase 1/2 studies of NTLA-2002 and NTLA-2001. NTLA-2002 aims to treat hereditary angioedema and will provide initial safety and kallikrein protein reduction data. NTLA-2001 targets ATTR amyloidosis, and an update on its cardiomyopathy arm will also be shared. Both candidates utilize CRISPR technology for gene editing, showing promise in their respective clinical trials. This event will be accessible online, and a replay will be available for 30 days.
Intellia Therapeutics, Inc. (NASDAQ:NTLA) announced that the FDA has granted orphan drug designation for its CRISPR-based genome editing candidate, NTLA-2002, aimed at treating hereditary angioedema (HAE). This candidate seeks to prevent HAE attacks after a single dose by knocking out the KLKB1 gene, reducing plasma kallikrein activity. Currently in a Phase 1/2 study, interim data will be presented on September 16, 2022, at the Bradykinin Symposium. Orphan designation provides several incentives, including tax credits and potential marketing exclusivity.
Intellia Therapeutics (NASDAQ:NTLA) announced the first clinical data on NTLA-2002, their novel CRISPR candidate, set for oral presentation at the Bradykinin Symposium on September 16, 2022. NTLA-2002 aims to prevent angioedema attacks in patients with hereditary angioedema (HAE) through a single-dose treatment strategy. The presentation will cover interim safety data, kallikrein reduction, and attack rates from the Phase 1/2 study. This innovative therapy represents a significant advancement in tackling the challenges associated with HAE, a rare genetic disorder affecting approximately 1 in 50,000 individuals.
Intellia Therapeutics (NTLA) recently announced significant progress in its Phase 1 study of NTLA-2001 for transthyretin (ATTR) amyloidosis. The company completed the dose-escalation portion for cardiomyopathy, with interim results showing deep, sustained TTR reductions for up to 12 months following a single dose. Intellia plans to focus solely on allogeneic cell therapies moving forward, including NTLA-5001. Financially, it ended Q2 2022 with $907 million in cash but reported a net loss of $100.7 million, up from $68.8 million in Q2 2021.
Intellia Therapeutics (NASDAQ:NTLA) will announce its Q2 2022 financial results on August 4, 2022, at 8 a.m. ET. The conference call will allow participants to discuss the operational highlights and financial metrics from the quarter. Interested parties can join via U.S. and international calling options, with a webcast available online. After the call, a replay will be accessible on Intellia's website. The company specializes in genome editing using CRISPR technologies, aiming to develop curative treatments for diseases.