SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Amphivena Therapeutics today highlighted initial data from the dose-escalation portion of the First-in-Human Phase 1 trial (AMV564-101, NCT03144245) evaluating AMV564 in patients with relapsed and/or refractory acute myeloid leukemia (AML) in an oral presentation at the 23rd European Hematology Association (EHA) meeting in Stockholm (Abstract S859). The data from 17 patients treated within 5 cohorts demonstrate that AMV564 engages and activates T cells resulting in leukemic cytoreduction. AMV564 is a bivalent, bispecific (2X2) T-cell engager that binds both CD33 and CD3 with strong avidity and results in T-cell directed lysis of CD33-expressing myeloid cells.
“AMV564 was designed to produce a longer half-life than the small monovalent bispecific T-cell engagers. Here, at EHA, the initial data presentation represents our first clinical proof-of-concept of T-cell engagement, T-cell activation, and leukemic cytoreduction in patients with heavily pre-treated, chemotherapy resistant AML,” said Eric J. Feldman M.D., Chief Medical Officer at Amphivena.
Peter Westervelt, M.D. Ph.D., Professor of Medicine at Washington University in St. Louis, and a Principal Investigator for the study, presented on behalf of the study team. He said, “AMV564 is a potent T-cell engager that is well tolerated by patients with AML. The pharmacokinetics are unprecedented with a gradual rise to steady state drug levels that may help mitigate cytokine release syndrome. The 0%, 30-day mortality rate in this high-risk population of AML patients is extremely encouraging, and we are seeing evidence of anti-leukemic activity even at very low doses.”
AMV564-101 is a First-in-Human dose escalation and dose expansion Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMV564 in patients with relapsed and/or refractory AML (NCT03144245). AMV564 is administered by continuous intravenous infusion (CIV) for 14 consecutive days for up to 2 induction cycles. Key inclusion/exclusion criteria are: adults with relapsed and/or refractory AML after 1-2 prior induction regimens (with a standard anthracycline-based regimen or hypomethylating agent) and no more than 2 prior salvage regimens. The Phase 1 study is currently open at Washington University, MD Anderson Cancer Center, and Weill-Cornell Medical College.
Amphivena Therapeutics, founded in 2013, is a private biotechnology company developing AMV564, a CD33/CD3 bivalent, bispecific (2X2) T-cell engager for the treatment of AML, MDS and solid tumors. MPM Capital and funds managed by Tekla Capital Management LLC led venture financings for the company with participation from Aeris Capital and Affimed GmbH. For more information, please visit www.amphivena.com.