Amphivena Demonstrates at EHA First Human Proof-of-Concept For AMV564 in Relapsed/Refractory AML

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.”

About AMV564-101

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.

About Amphivena

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

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