Amphivena Initiates Solid Tumor Clinical Trial

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.

About AMV564

AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3. To date, over 50 patients have received AMV564 in two Phase 1 clinical trials for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). It is currently being evaluated in a First-in-Human Phase 1 trial in patients with relapsed/refractory AML at Washington University School of Medicine, MD Anderson Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

The safety, efficacy and selectivity of AMV564 was highlighted most recently at both the 24^th European Hematology Association (EHA) meeting in Amsterdam (Abstract S877) and at the 60^th Annual Meeting of the American Society of Hematology in San Diego, CA last December. Amphivena believes that AMV564 has demonstrated novel clinical activity by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes.

AMV564 is also being evaluated in a Phase 1 solid tumor study which is currently open to enrollment.

About Amphivena

Amphivena Therapeutics, Inc. is an immuno-oncology company based in South San Francisco, CA that is developing best-in-class T cell engagers for cancer. The company’s lead therapeutic candidate, AMV564, is a bivalent, bispecific CD33/CD3 T cell engager that potently and selectively eliminates leukemic blasts and myeloid derived suppressor cells (MDSC), sparing normal myeloid cells (e.g., neutrophils and monocytes). AMV564 has an excellent safety profile that enables competitive approaches, including combination therapy, and provides a unique opportunity to explore the role of MDSC in solid tumors.

Amphivena has raised $88.5 M to date in Series A, B and C venture financings led by NanoDimension, Qiming Venture Partners USA, MPM Capital and funds managed by Tekla Capital Management LLC. For more information, please visit www.amphivena.com.

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