Amphivena Presents Translational Data for its Lead Clinical Candidate, AMV564 at the AACR 2020 Virtual Annual Meeting II

  • AMV564, a novel first-in-class agent that depletes MDSC and polarizes T cells, is being investigated in Ph1 clinical trials in advanced solid tumors and hematological cancers and is well tolerated with single-agent activity across both solid and heme malignancies
  • AMV564 translational data for MDSC depletion, Treg control, favorable effector CD8 and CD4 Th1 polarization, along with a cytokine and chemokine milieu conducive to T cell trafficking and antigen presentation is consistent with relief of immune suppression



SOUTH SAN FRANCISCO, Calif., June 23, 2020 /PRNewswire/ — Amphivena Therapeutics, a clinical-stage immuno-oncology company focused on developing immuno-therapeutics that restore anti-cancer immunity, today presents translational data for the lead clinical candidate from its ReSTORE (Relieve Suppression of T cells in Oncology and Reinvigorate Effectors) platform of bivalent T-cell engagers, AMV564, at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II.
Findings presented include:

  • AMV564 administration by subcutaneous route in solid tumor patients was well tolerated; no cytokine release syndrome or dose-limiting toxicities have been observed
  • Reduction in both MDSC and regulatory T cells was apparent, consistent with relief of immune suppression
  • AMV564 promoted favorable effector CD8 and CD4 Th1 polarization in patients, along with a cytokine and chemokine milieu conducive to T cell activation and trafficking, and antigen presentation
  • The clinical benefit was highlighted by a confirmed complete response (RECIST 1.1) with AMV564 monotherapy treatment in a patient following several prior lines of therapy (including prior checkpoint inhibitor)

“The translational data we are presenting at AACR provides further validation and informs our clinical observations with AMV564 and its dual actions to relieve immune suppression via MDSC depletion and concomitant activation and polarization of effector CD8 and Th1 CD4 T cells, representing a new treatment paradigm for cancer,” said Curtis Ruegg, Ph.D., Chief Executive Officer of Amphivena Therapeutics. “We look forward to expanding this study to additional selected patient cohorts who could benefit from this mechanism of action”.

Details of the Presentation:

  • Session Title: Novel Immunotherapies and Mechanisms
  • Session Start Date/Time: Tuesday, June 23, 2020, 9:00 – 10:45 AM ET
  • Title: AMV564, a bivalent, bispecific T-cell engager, depletes myeloid-derived suppressor cells and activates T cells in cancer patients
  • Authors: Victoria Smith, et al.
  • Oral Presentation Number: 5699


The presentation is available on the AACR Annual Meeting website and in addition, the presentation recording and slides are available on the Presentations & Publications page on the Amphivena website.

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).

About Amphivena Therapeutics, Inc.
Amphivena Therapeutics, Inc. is a privately held, clinical-stage, immuno-oncology company based in South San Francisco, CA that is developing a novel platform of dual-action biologics to selectively relieve immune suppression and drive T-cell activation/polarization, to restore anti-cancer immunity in patients. The company’s lead therapeutic candidate, AMV564, induces selective T-cell mediated killing of myeloid derived suppressor cells (MDSC), known to be associated with immune suppression and poor outcomes to immunotherapy. In parallel, it drives improved T cell effector function. AMV564-induced immune restoration is optimized by targeting the lymphoid tissues through subcutaneous delivery where immunoregulation occurs. AMV564 has exhibited an excellent clinical safety profile and combinability with checkpoint inhibition and represents a unique opportunity to bring new treatment options to cancer patients underserved by immunotherapy.

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.

Alicia Chung, Corporate Development
+1 650 499-3178