On May 29, 2020 Amphivena Therapeutics, a clinical-stage immuno-oncology company focused on developing immunotherapeutics that restore anti-cancer immunity to the patient, reported data from a Phase 1 study of its lead clinical candidate AMV564 in a poster presentation at the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Amphivena Therapeutics, MAY 29, 2020, View Source [SID1234558758]).
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The Phase 1 dose escalation study (NCT04128423) has enrolled 18 advanced solid tumor patients at the time of data cut off. AMV564 was administered once daily via subcutaneous injection, either alone or in combination with pembrolizumab for 2 weeks out of every 3-week cycle.
AMV564 was well tolerated with no dose-limiting toxicities reported in monotherapy or combination therapy cohorts. Assessment of the pharmacodynamic effects of AMV564 using patient blood samples at various timepoints demonstrated depletion of myeloid derived suppressor cells (MDSC) and increases in CD8:Treg ratio with AMV564 treatment.
AMV564 demonstrated single-agent activity including one complete response in a patient with heavily pre-treated (including prior checkpoint inhibitor therapy) ovarian cancer, who remains on study after 10 cycles of treatment. The disease control rates for the monotherapy and combination arms were 45 percent and 29 percent, respectively.
Details of the Presentation:
Title: A Phase 1 Study to Evaluate the T-cell Engager AMV564 Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Authors: Starodub, A. et al.
Abstract Number: 3101 (Poster: 165)
The full abstract and poster will be available on ASCO (Free ASCO Whitepaper) conference and Amphivena websites as of 8:00AM ET on Friday, May 29th.
About AMV564
AMV564 relieves immune suppression via targeted depletion of MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 80 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).