Rationale for Expansion of AMV564 into Solid Tumors

Selectivity of AMV564 Presents Opportunity in Patients with Solid Tumors

South San Francisco, CA – November 7, 2019 — Amphivena Therapeutics, Inc., a private clinical stage immuno-oncology company developing T cell engager therapeutics for cancer, will present at the Society for Immunotherapy in Cancer (SITC) Annual Meeting on November 7 new understandings of the mechanism of action of its T cell engager clinical candidate, AMV564. Specifically, Amphivena said that AMV564, a bivalent CD33/CD3 T cell engager, selectively depletes myeloid-derived suppressor cells (MDSC) in patients, sparing normal neutrophils and monocytes. The company announced in October initiation of a Phase 1 trial 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.

Vitoria Smith Ph.D., Chief Scientific Officer, who will make the oral presentation, noted, “AMV564 selectively reduces MDSC in the bone marrow and periphery in acute myeloid leukemia and myelodysplastic syndrome patients.  In addition, we observed that T cell activation on therapy can lead to rapid increases in MDSC.  However, this can be modulated by AMV564 due to avid binding of activated CD33 on MDSC. We believe that with application of a continuous dosing regimen we may control immune-suppressive MDSC and promote anti-tumor immunity.”

The oral presentation (071) is scheduled for 2:25 pm ET in Potomac Ballroom CD.

Amphivena will also present a “Trials in Progress” poster summarizing the study design and objectives of its ongoing study AMV564-301 “Phase 1 Dose Escalation with Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of AMV564 in Patients with Advanced Solid Tumors” (NCT04128423). 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.  AMV564 is being administered to solid tumor patients by subcutaneous injection.

The poster presentation (P416) is scheduled for 7:00 pm – 8:30 pm ET in Prince George’s Exhibition Hall AB.

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 24th European Hematology Association (EHA) meeting in Amsterdam (Abstract S877) and at the 60th 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.

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.

Shari Annes