Amphivena Presents at ASH First-in-Human Phase 1 Clinical Data on AMV564
“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 www.amphivena.com.
Source: Amphivena Therapeutics, Inc.