Amphivena Initiates Solid Tumor Clinical Trial

Amphivena is set to move on with AMV564 in a Multi-Center Dose Finding Phase 1 Clinical Study in Patients with Solid Tumors.

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, today announced dosing of the first patient in a Phase 1 clinical trial in solid tumors evaluating AMV564, a CD33/CD3 T cell engager that selectively eliminates myeloid derived suppressor cells (MDSC), sparing normal neutrophils and monocytes.

“Our lead candidate, AMV564, originating from our platform technology, is a bivalent T cell engager that binds with high avidity and specificity to CD33. AMV564 has been shown to eliminate subsets of activated myeloid cells, including granulocytic, monocytic and immature MDSC, in acute myeloid leukemia patients,” said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President. “This creates a unique opportunity for Amphivena to evaluate the effect of AMV564 on these immune suppressive cells and the potential therapeutic benefit of relieving this important source of T cell suppression in patients with solid tumors.”

The multi-center Phase 1 study is currently open for enrollment at NEXT Oncology (PI: Raghad Karim) in San Antonio, TX, MD Anderson Cancer Center (PI: Sarina Piha-Paul) and Peninsula Cancer Institute (PI: Alexander Starodub) in Newport News, VA. The study will be a multicenter, all-comers solid tumor dose-finding trial with expansion cohorts planned in 2020. AMV564 is being administered to solid tumor patients by subcutaneous injection.