On June 23, 2020 Amphivena Therapeutics, a clinical-stage immuno-oncology company focused on developing immuno-therapeutics that restore anti-cancer immunity, reported 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) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II (Press release, Amphivena Therapeutics, JUN 23, 2020, View Source [SID1234561422]).
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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 (Free AACR Whitepaper) 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 (Free AACR Whitepaper) 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).