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Aptevo Therapeutics Announces Expansion Phase of Lead Anti-Leukemia Drug APVO436 in Adult Patients with Acute Myeloid Leukemia
Initiates Multi-Center, Multi-Arm Trial Using Active Dose Identified in the Dose Escalation Phase of the TrialSEATTLE, WA / ACCESSWIRE / May 27, 2021 / Aptevo
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Initiates Multi-Center, Multi-Arm Trial Using Active Dose Identified in the Dose Escalation Phase of the TrialSEATTLE, WA / ACCESSWIRE / May 27, 2021 / Aptevo Therapeutics Inc. (\"Aptevo\") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIRTM and ADAPTIR-FLEXTM platform technologies today announced that the company has initiated the expansion phase of lead anti-leukemia drug candidate, APVO436, in adult patients with acute myeloid leukemia (AML) with a multi-center, multi-arm trial using the active recommended dose identified in the dose escalation phase (Part 1) of the study. During Part 1, APVO436 exhibited a manageable side effect profile, encouraging single agent activity and a promising benefit to risk profile in relapsed AML patients. The Company has plans to submit data from the dose escalation phase for publication later this year.The dose expansion phase (Part 2), has been rationally designed to further evaluate the tolerability and clinical impact potential of APVO436 for indications of unmet and urgent medical need. During Part 2, the dose expansion phase of the study, a total of 90 AML patients will be enrolled into 5 cohorts of 18 patients each, as explained in the detailed and publicly available study information provided at CinicalTrials.gov (NCT03647800) The study will be conducted under an FDA-approved IND and has been Central IRB-approved. Patient enrollment is anticipated to commence in June. The goal of the expansion phase is to evaluate the safety and tolerability of APVO436 at the recommended Phase 2 dose level, when it is used as an adjunct to the standard of care and to obtain a preliminary assessment of the anti-leukemia activity of APVO436 containing experimental monotherapy and combination therapy modalities.Protocol-specific training has started for the participating academic cancer centers in the US. Aptevo is planning to conduct Part 2 of the study at up to 20 clinical trial sites.\"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen\" explained Dr. Fatih Uckun, leukemia expert and Chief Clinical Advisor. \"By combining APVO436 with the standard of care, Aptevo hopes to develop an innovative approach that impr...