Amphivena Reports Data on Phase 1 Study of AMV564 at Ash Annual Meeting

December 9, 2019 Off By BusinessWire

Early evidence of clinical activity and robust safety findings highlighted

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, presented today at the American Society of Hematology annual meeting data from a Phase 1 study of its bivalent T cell engager clinical candidate, AMV564. In an oral presentation, Dr. Jorge E. Cortes, of the Georgia Cancer Center, Augusta University, Augusta, Georgia, said that the data provide early evidence of safety and clinical activity with evidence of T cell activation, increases in bone marrow T cells, and anti-leukemic blast activity. Of the 38 patients for whom response data was reported, five had Complete or Partial Responses as defined by the European LeukemiaNet (ELN) criteria.

“AMV564 was shown to be safe and well-tolerated, with no dose-limiting toxicities and no Grade 3+ Cytokine Release Syndrome (CRS), at doses up to 450 mcg/day in heavily pre-treated relapsed/refractory AML patients when administered by continuous IV infusion with a 14-day dosing regimen,” said Dr. Cortes. “These findings provide a differentiated product profile that we believe should be further advanced in clinical development.”

“We are pleased with the early signs of efficacy and safety in this First in Human clinical trial, and we are exploring subcutaneous and chronic dosing of AMV564 in other clinical trials,” said Curtis Ruegg, Ph.D., President and CEO of Amphivena. “AMV564’s excellent safety profile supports conduct of combination trials of AMV564 with other agents as we look ahead into the AMV564 development program.”

As of the data cutoff, 41 patients had been dosed with AMV564 and 11 dose cohorts were explored in a 14-day continuous IV dosing regimen. The primary objectives of the Phase 1 dose escalation study are to characterize the safety of AMV564 as well as identify a maximum tolerated dose and a recommended Phase 2 dose.

The presentation was made at 5:45 PM EST in the Chapin Theater (W320), Orange County Convention Center, Orlando, FL.

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 the Society for Immunotherapy in Cancer (SITC) Annual Meeting on November 7 where it was reported that AMV564 selectively reduces MDSC in the bone marrow and periphery in acute myeloid leukemia and myelodysplastic syndrome patients. The company also observed at SITC that T cell activation on therapy can lead to rapid increases in MDSC that can be modulated by AMV564 due to avid binding of activated CD33 on MDSC. Amphivena also presented data at the 24th European Hematology Association (EHA) meeting in Amsterdam (Abstract S877). 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.

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


Shari Annes, Annes Associates

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