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Aptevo Therapeutics Provides Update On Ongoing APVO436 Phase 1 Clinical Trial
Trial Advancing on Schedule with Dosing in Cohort 6 Set to Begin Shortly;Dose Levels Now Entering Potential Therapeutic Range No Evidence of Dose-Limiting
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Trial Advancing on Schedule with Dosing in Cohort 6 Set to Begin Shortly;Dose Levels Now Entering Potential Therapeutic Range No Evidence of Dose-Limiting Toxicities Observed in Cohort 5No Evidence of Drug-Induced Anti-Drug Antibodies Observed to Date SEATTLE, WA / ACCESSWIRE / March 16, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, today provided an update on its ongoing Phase 1/1b clinical trial of APVO436, a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS.)At present, dosing in cohorts 1 through 5 has been completed with dosing in cohort 6 scheduled to begin shortly. A total of 19 patients have been enrolled and treated with APVO436 to date. No evidence of dose-limiting toxicities was observed in the latest dose cohort (cohort 5.) A dose-limiting toxicity was observed in 1 of 6 patients in cohort 4. Also, importantly, no evidence of drug-induced anti-drug antibodies (ADA) has been observed in the 17 patient blood samples analyzed to date.One patient in the study with a diagnosis of MDS is currently finishing an 8th cycle of dosing. Preliminary analysis showed that this patient has achieved a disease assessment of \"marrow complete response,\" which is defined as a bone marrow with ≤ 5% myeloblasts and a decrease ≥ 50% over pretreatment. Changes in peripheral blood measurements are reported separately and this particular patient continues to require platelet and red blood cell transfusions. Aptevo cautions that these data are preliminary.\"The evolving data from our Phase 1 study of APVO436 continues to look promising,\" said Marvin L. White, President and Chief Executive Officer. \"While still preliminary, we are encouraged by the early evidence of a clinical response observed with APVO436 for a patient in cohort 4. Notably, we believe this is a subtherapeutic dose, so the potential clinical activity observed is especially intriguing. Importantly, we are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug...