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Press Release

Amphivena Presents at ASH First-in-Human Phase 1 Clinical Data on AMV564

Amphivena Therapeutics,Inc.
Posted on: 03 Dec 18

Amphivena Therapeutics, Inc., a privately held biotechnology company developing AMV564, a CD33/CD3 T cell engager for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), presented Saturday night in a poster presentation at the 60th Annual Meeting of the American Society of Hematology first-in-human Phase 1 clinical data that demonstrate that in patients with relapsed/refractory AML, AMV564 is well-tolerated and has anti-leukemic activity through T-cell engagement. The data from this ongoing dose escalation trial further show that AMV564 has a unique PK profile with a gradual increase in drug exposures that mitigates cytokine release syndrome (CRS).

“The ASH data reports continued evidence of single-agent clinical activity in heavily pre-treated patients with refractory/relapsed AML. AMV564 has been well-tolerated and has the potential to be safely combined with other agents. Importantly, its 2-day half-life supports intermittent dosing which differentiates AMV564 from other T cell engagers in development for myeloid malignancies,” said Eric J. Feldman, M.D., Amphivena’s Chief Medical Officer.

The poster highlights the safety and efficacy data on 26 evaluable patients, as follows:

  • Complete and partial responses (CRi, PR) observed in patients dosed at 100 mcg with a 14-day dosing regimen
  • No dose-limiting toxicity through the 150 mcg cohort, with a 0% 30-day mortality rate
  • No Grade 2+ CRS with a lead-in dose and no Grade 3+ CRS
  • Novel pharmacokinetic profile with a 2-day terminal half-life

A seamless Phase 1/2 study is ongoing at six centers in the U.S.

About Amphivena Therapeutics, Inc.

Amphivena Therapeutics, Inc. is a private biotechnology company developing AMV564, a bivalent, bispecific (2:2) CD33/CD3 T cell engaging antibody for the treatment of myeloid malignancies and solid tumors, with ongoing seamless Phase 1/2 studies in AML and MDS. Amphivena has raised $26.5 M to date in Series A and B venture financings led by MPM Capital and funds managed by Tekla Capital Management LLC. For more information, please visit

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Last updated on: 03/12/2018

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