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Spyre Therapeutics, Inc. (NASDAQ: AGLE) is a biotechnology company dedicated to advancing a robust pipeline of antibody therapeutics aimed at transforming the treatment of inflammatory bowel disease (IBD). The company was formed following the acquisition by Aeglea BioTherapeutics in June 2023, shifting the focus from rare metabolic diseases to innovative IBD treatments. Spyre combines advanced antibody engineering, rational therapeutic combinations, and precision immunology to maximize the efficacy, safety, and convenience of its treatments.
With a promising portfolio, Spyre's lead programs—SPY001 and SPY002—focus on targeting α4β7 and TL1A, respectively.
- SPY001: This program involves a highly potent and selective anti-α4β7 monoclonal antibody, engineered with half-life extension technology for high-concentration, convenient dosing. It is expected to enter first-in-human studies in the first half of 2024, with interim data anticipated by the end of 2024.
- SPY002: A highly potent anti-TL1A monoclonal antibody engineered for half-life extension, targeting both TL1A monomers and trimers with exceptional binding affinity. First-in-human studies are expected to commence in the second half of 2024, with interim data anticipated in the first half of 2025.
Additionally, Spyre is developing SPY003, a monoclonal antibody targeting the p19 subunit of IL-23, expected to enter clinical trials in 2025.
The company operates with robust financial health, having successfully raised $210 million through a private placement in June 2023, and is positioned to fund its operations into 2026. Spyre aims to address the significant and growing IBD market, which includes conditions like Crohn's disease and ulcerative colitis, affecting approximately 1.7 million patients in the United States alone.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced the appointment of Marcio Souza to its board of directors. Mr. Souza, currently the CEO of Praxis Precision Medicines, brings extensive experience in rare diseases and global commercial strategy. Aeglea is at a critical growth stage, aiming to transition into a commercial-stage company. With key Phase 3 data from the Arginase 1 Deficiency program expected in late 2021 and a new Homocystinuria program underway, the company positions itself for significant developments in rare metabolic disease treatments.
Aeglea BioTherapeutics (NASDAQ:AGLE) reported its Q1 2021 financial results, highlighting significant advancements in its pegzilarginase program for treating rare metabolic diseases. Aeglea secured a licensing agreement with Immedica Pharma, receiving $21.5 million upfront, and anticipates up to $130 million in milestones and royalties. The company completed patient randomization for the PEACE Phase 3 trial, exceeding enrollment targets. Despite a net loss of $18.2 million, cash reserves total $128.5 million, ensuring funding through 2023. Major developments are setting the stage for potential FDA approval.
Aeglea BioTherapeutics (NASDAQ:AGLE) launched the THINK ARGININE initiative on May 6, 2021, aimed at enhancing awareness and diagnosis of Arginase 1 Deficiency (ARG1-D). This rare metabolic disorder leads to serious health challenges, including mobility issues and developmental delays. The initiative offers no-charge diagnostic testing in partnership with Mayo Clinic Laboratories and Invitae. By improving diagnostic accuracy, Aeglea intends to foster better treatment outcomes for patients suffering from this debilitating condition.
Aeglea BioTherapeutics (NASDAQ: AGLE) announced completion of patient randomization for the PEACE Phase 3 trial of pegzilarginase, targeting Arginase 1 Deficiency (ARG1-D), a rare and severe disorder. The trial exceeded its recruitment target with 32 patients enrolled during the COVID-19 pandemic, highlighting the need for effective treatments. Topline results are expected in Q4 2021. Pegzilarginase, a recombinant human enzyme, aims to significantly lower plasma arginine levels, addressing the disease's root cause. The treatment has received multiple FDA designations, emphasizing its potential importance.
Aeglea BioTherapeutics (NASDAQ:AGLE) announced its participation in two virtual investor conferences in April 2021. The first event is the 2021 Virtual Wells Fargo Biotech Corporate Access Day on April 6 and 8, featuring CEO Anthony G. Quinn. The second is the 20th Annual Needham Virtual Healthcare Conference, taking place April 12-15, with a presentation by Quinn on April 13 at 11:00 am ET. This biotechnology company focuses on developing human enzyme therapeutics for rare metabolic diseases, including its lead product candidate, pegzilarginase.
Aeglea BioTherapeutics (NASDAQ:AGLE) has entered a license and supply agreement with Immedica Pharma for pegzilarginase, a recombinant human enzyme aimed at treating Arginase 1 Deficiency (ARG1-D). The agreement includes a $21.5 million upfront payment and potential milestone payments of up to $130 million, along with royalties on net sales. Pegzilarginase, currently in a pivotal Phase 3 clinical trial, has demonstrated positive effects in earlier studies, including reductions in plasma arginine levels and a favorable safety profile.
Aeglea BioTherapeutics (NASDAQ:AGLE) reported its fourth quarter and full year 2020 financial results on March 18, 2021. The company is focused on developing human enzyme therapeutics for rare metabolic diseases amid challenges from COVID-19. Key highlights include enrollment of 24 patients in the Phase 3 PEACE trial for pegzilarginase and FDA designation for AGLE-177 in Homocystinuria. Aeglea's cash reserves stood at $148.1 million, expected to sustain operations into 2023. Net losses increased to $22.7 million for Q4 2020 from $21.5 million in Q4 2019. Overall, 2021 is anticipated to be transformative.
Aeglea BioTherapeutics (NASDAQ: AGLE) has appointed Sara Brownstein to its board of directors. Brownstein, a principal at Baker Bros. Advisors LP, brings over a decade of life sciences investing experience. CEO Anthony Quinn welcomed her expertise, noting its importance as the company approaches significant milestones, including topline data from a pivotal Phase 3 trial for pegzilarginase in treating Arginase 1 Deficiency and the initiation of a Phase 1/2 trial for AGLE-177 for Homocystinuria. Aeglea focuses on developing innovative enzyme therapeutics for rare metabolic diseases.
Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) announced that CFO Charles N. York II will depart on February 12, 2021, to join an oncology company. A search for a new CFO is underway, with Steven Weber appointed as principal accounting officer. York reflected on nearly seven years at Aeglea, highlighting the company’s growth into a clinical-stage biotech firm with two clinical programs. Aeglea's lead candidate, pegzilarginase, is in a Phase 3 trial for Arginase 1 Deficiency, with Rare Pediatric Disease and Breakthrough Therapy Designations.
Aeglea BioTherapeutics (NASDAQ:AGLE), a clinical-stage biotechnology company, announced its presentation at the 39th Annual J.P. Morgan Healthcare Conference from January 11-14, 2021. The presentation will occur on January 13 at 8:20 a.m. EST, led by CEO Anthony G. Quinn. A webcast of the event will be available for live and archived access. Aeglea focuses on developing therapeutics for rare metabolic diseases, with its lead candidate, pegzilarginase, in Phase 3 trials for Arginase 1 Deficiency, and AGLE-177 in Phase 1/2 trials for Homocystinuria.
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