SOUTH SAN FRANCISCO, Calif., Dec. 16, 2020 /PRNewswire/ -- Amphivena Therapeutics, a clinical-stage oncology company focused on developing a platform of bivalent T-cell engagers that restore anti-cancer immunity in patients, today announced the first patient has been dosed in the Phase 1 dose expansion study evaluating AMV564, an investigational, first-in-class agent that depletes myeloid derived suppressor cells (MDSC) and activates T cells, in adult patients with selected solid tumor indications.
The dose escalation phase of the first-in-human, multicenter, open-label study of AMV564 in solid tumors was initiated in October 2019 and established the safety, PK profile and clinical activity of AMV564 including a confirmed RECIST complete response.
The dose expansion study will explore AMV564 as a monotherapy in tumor-specific cohorts selected to enrich for patients with actionable antigens. The primary objectives of the study are to further characterize the safety and tolerability and to evaluate preliminary efficacy of AMV564 monotherapy administered subcutaneously.
"AMV564 has demonstrated an excellent safety profile and encouraging preliminary activity in heavily pretreated patients, and we look forward to seeing how this novel mechanism translates to clinical benefit in selected cancer patient populations including patients with inadequate benefit from checkpoint inhibitors, representing an area of high unmet need," said Curtis Ruegg, Ph.D., President and Chief Executive Officer of Amphivena Therapeutics.
The trial is being conducted at a planned 15 sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT04128423).
AMV564 relieves immune suppression via targeted depletion of immunosuppressive MDSC and drives T cell activation and polarization to restore anti-cancer immunity. To date, over 95 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, oncology company based in South San Francisco, CA with a mission to restore anti-cancer immunity in patients and to take cancer treatment beyond the limits of immunotherapy. Our proprietary Amphivena ReSTORETM (Relieve Suppression of T cells in Oncology and Reinvigorate Effectors) platform of bivalent T-cell engagers is designed to selectively relieve immune suppression and drive T-cell activation/polarization 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 offer 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.