On December 3, 2018 Amphivena Therapeutics, Inc., reported 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 (ASH) (Free ASH Whitepaper) 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 (Press release, Amphivena Therapeutics, DEC 3, 2018, View Source [SID1234531842]). 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).
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"The ASH (Free ASH Whitepaper) 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.