{"content":[{"text":"Caelum and Alexion Present Additional Phase 2 Data Reinforcing Safety \n and Tolerability of CAEL-101 in AL Amyloidosis at the European \n Hematology Association Congress 2021","bbox":{"left":0.096863,"top":0.138678,"width":0.806362,"height":0.075575}},{"text":"- Exploratory biomarker analyses suggest possible cardiac disease improvements and renal response -","bbox":{"left":0.112392,"top":0.23331,"width":0.775223,"height":0.015804000000000012}},{"text":"BORDENTOWN, N.J. & BOSTON, MA – JUNE 11, 2021 – Caelum Biosciences and Alexion Pharmaceuticals, Inc. \n (NASDAQ:ALXN) today announced new Phase 2 safety and tolerability data for CAEL-101, a potentially first-in- \n class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in patients with AL \n amyloidosis. The data, presented in two e-posters at the European Hematology Association (EHA) Congress \n 2021, strengthen the safety and tolerability profile of CAEL-101, further support the dose selection for the \n ongoing Phase 3 study, and suggest possible cardiac and renal response. An e-poster featuring the first data \n from a new arm of the study demonstrated that CAEL-101 administered in combination with cyclophosphamide- \n bortezomib-dexamethasone (CyBorD) plus daratumumab was generally safe and well-tolerated in the first four \n weeks of treatment. Data presented in a second e-poster showed longer-term evidence that CAEL-101 in \n combination with CyBorD was generally well-tolerated for a median treatment duration of 49 weeks, and \n exploratory clinical biomarker data suggesting possible cardiac disease improvements and renal response \n among patients with cardiac or renal impairment at baseline, respectively.","bbox":{"left":0.081765,"top":0.274409,"width":0.8370440000000001,"height":0.22370799999999996}},{"text":"“AL amyloidosis is a relentless disease that is particularly devastating when it impacts the heart, with some of \n these patients facing a median survival of less than one year following diagnosis. Current treatments for AL \n amyloidosis are designed to prevent or suppress the formation of new amyloids, but they do not address the \n existing amyloid buildup in the involved organs like the heart and kidneys, which can result in continued organ \n damage and can ultimately be fatal,” said Michael Spector, President and Chief Executive Officer of Caelum. \n “Understanding that CAEL-101 has the potential to be the first therapy to address the devastating organ damage \n caused by AL amyloidosis, we are urgently working to advance the ongoing CARES Phase 3 program in \n collaboration with Alexion.”","bbox":{"left":0.081765,"top":0.52004,"width":0.837026,"height":0.1481150000000001}},{"text":"Safety and Tolerability of CAEL-101 in Combination with Cyclophosphamide-Bortezomib-Dexamethasone and \n Daratumumab in Patients with AL amyloidosis (#EP1017)","bbox":{"left":0.081765,"top":0.69023,"width":0.836844,"height":0.03459100000000004}},{"text":"As was previously announced, the Phase 2 study of CAEL‑101 in combination with CyBorD met its primary \n objectives, supporting the safety and tolerability of CAEL-101 and the selection of the 1000 mg/m2 dose for the \n ongoing Phase 3 study. Results presented from an additional study arm that included 11 patients receiving \n CAEL-101 (1000 mg/m2 dose) in combination with CyBorD plus daratumumab suggested that treatment with \n this combination was generally well-tolerated in the first four weeks of treatment. Specifically, adding \n daratumumab to the CAEL-101 and CyBorD regimen did not result in any new safety signals, nor did it alter the \n pharmacokinetic (PK) exposure to CAEL-101. The most common adverse events (AEs) reported in the first four \n weeks in the additional arm were nausea, constipation, and insomnia.","bbox":{"left":0.081765,"top":0.747502,"width":0.8369989999999999,"height":0.14810200000000007}},{"text":"1","bbox":{"left":0.494788,"top":0.948437,"width":0.010579000000000005,"height":0.01580400000000004}}],"images_bbox":[{"left":0.292075,"top":0.054293,"width":0.187059,"height":0.080871},{"left":0.479167,"top":0.065025,"width":0.228758,"height":0.070707}],"images_bbox_not_text_overlap":[{"left":0.292075,"top":0.054293,"width":0.187059,"height":0.080871},{"left":0.479167,"top":0.065025,"width":0.228758,"height":0.070707}]}