Business
Aptevo Therapeutics Reports 2022 Financial Results and Provides Business Update
Company Achieves Multiple Clinical and Scientific Milestones in 2022, Poised for APVO436 Phase 2 in AML 2H23, ALG.APV-527 dosing initiated 1Q23 for Solid
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Company Achieves Multiple Clinical and Scientific Milestones in 2022, Poised for APVO436 Phase 2 in AML 2H23, ALG.APV-527 dosing initiated 1Q23 for Solid TumorsSEATTLE, WA / ACCESSWIRE / March 30, 2023 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the year ended December 31, 2022 and business highlights.2022 HighlightsAPVO436 (Acute Myeloid Leukemia)In December 2022 we announced that APVO436, in combination with venetoclax and azacitidine, demonstrated substantial clinical activity and a favorable safety and tolerability profile in adult venetoclax treatment naïve AML patients. More specifically:The combination of venetoclax and azacitidine with APVO436 in venetoclax treatment naïve response-evaluable patients in Cohort 2 of the Phase 1b study outperformed a composite benchmark across all clinical benefit categories (Benchmark Composite References:Aldoss 2019 , Maiti 2021 , Morsia 2020 , Garciaz 2022 , Feld 2021)The data, which was presented in a poster session at the 64th American Society of Hematology Annual Meeting and Exposition (ASH) in New Orleans, also showed that APVO436, when given in combination with venetoclax and azacitidine was observed to be generally safe and well toleratedBased on Phase 1b outcomes, we plan to initiate a Phase 2 trial in the second half of 2023 to further evaluate APVO436 in combination with venetoclax and azacitidine in venetoclax treatment naïve patientsALG.APV-527 (solid tumors)In September 2022, we received a \"may proceed\" notification from the U.S. Food and Drug Administration (FDA), allowing us and our partner, Alligator Bioscience, to initiate clinical trials evaluating the compound for the treatment of 5T4-expressing tumors in multiple solid tumor types. A first-in-human study was initiated in the first quarter of 2023.The first patient in this trial was dosed in February 2023. Patient recruitment is ongoing. ALG.APV-527 targets 4-1BB co-stimulatory receptor (on T lymphocytes and NK cells) and 5T4 (solid tumor antigen) and is designed to promote anti-tumor immunity.The Preclinical PipelineOn January 9, 2023, Aptevo filed a provisional patent with the U.S. Patent and Trademark Office (US...