Business
Aptevo Therapeutics Reports 2023 Financial Results and Provides a Business Update
Announces 1H24 Plan for Development of Lead Candidate APVO436 for the Treatment of Frontline Acute Myeloid Leukemia, Interim Results Expected Late
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Announces 1H24 Plan for Development of Lead Candidate APVO436 for the Treatment of Frontline Acute Myeloid Leukemia, Interim Results Expected Late 2H24ALG.APV-527 Phase 1 Trial for the Treatment of Multiple Solid Tumors Continues Enrollment, Interim Results Expected 1H24SEATTLE, WA / ACCESSWIRE / March 5, 2024 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today reported financial results for the year ended December 31, 2023 and provided a business update.Business UpdateAPVO436APVO436, Aptevo's CD3 x CD123 bispecific, is currently in clinical development for the treatment of acute myeloid leukemia (AML), of which there are approximately 20,000 new diagnoses and 11,000 deaths annuallyIn 2023, the Company concluded a multi-center, multi-cohort dose expansion study. Trial results showed a 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax naïve patients, a less than 30% incidence of CRS across all trial cohorts (the majority were grades 1 &2) and meaningful duration of remission, including three patients who transitioned to transplant after receiving therapy. Transplant is the best possible outcome for AML patientsUpon review of this data and in consultation with the FDA, Aptevo intends to initiate an open- label Phase 1b/2 trial in 1H24 to further evaluate APVO436 in combination with the current standard of care, venetoclax + azacitidine, in frontline, venetoclax naïve AML patientsThe first part of the trial consists of a Phase 1b dose optimization study that will explore multiple doses of APVO436 in combination with venetoclax + azacitidine and is expected to add to the existing body of clinical data supporting further development of APVO436 in AMLThe Company plans to report interim data in late 2H24\"We are excited about our results and have compiled a significant body of data around APVO436 based on the trials we have completed to date. For example, we know it is safe, well tolerated, clinically active and shows a favorable duration of remission. For the next step in our APVO436 clinical program, we will target frontline AML patients who are venetoclax treatment naïve. Other populations that may benefit from APVO436, and therefore ...