Amphivena Presents New Monotherapy and First Combination Therapy Clinical Data in Solid Tumor Patients

  • Investigational Drug Candidate AMV564 Demonstrates Safety with Evidence of Anti-tumor T cell Expansion and One Complete Response, Multiple Mixed Responses and Durable Disease Stabilization in Solid Tumor Patients
  • No Cytokine Release Syndrome (CRS) reported in patients treated with subcutaneously administered AMV564 alone and in combination with Pembrolizumab at doses selected for expansion cohorts
  • Monotherapy dose escalation demonstrates safety and efficacy of subcutaneously (sc) administered AMV564, including a RECIST complete response (CR)
  • AMV564 shown to deplete immunosuppressive MDSC, significantly activate effector CD8+ cells and Th1 T cells, and promote expansion of anti-tumor T cells
  • Phase 1 data support dose and schedule of AMV 564 for expansion cohorts in selected solid tumor indications

South San Francisco, CA – June 4, 2021Amphivena Therapeutics, a clinical-stage oncology company focused on developing immune-therapeutics that restore anti-cancer immunity to patients, today reported a favorable safety profile for AMV564 and clinical responses including a CR in patients with advanced relapsed or refractory solid tumors. The poster presentation at the 2021 virtual American Society of Clinical Oncology (ASCO) Annual Meeting disclosed the first comprehensive set of clinical results from Amphivena’s Phase 1 dose escalation study of AMV564 dosed subcutaneously (sc) as monotherapy or in combination with pembrolizumab, including in post checkpoint treatment failures.

Poster authors representing Duke University, The Christ Hospital of Cincinnati, OH, MD Anderson Cancer Center, NEXT Oncology, and Moffitt Cancer Center concluded that AMV564 delivered subcutaneously was well tolerated with no dose-limiting toxicities and no maximum tolerated dose reported. Additionally, clinical responses were observed in both monotherapy and combination therapy patients, including durable stable disease, mixed responses, and a RECIST v1.1 complete response (ovarian cancer patient treated with AMV564 monotherapy). Importantly, no cases of CRS were observed at the planned dose expansion doses.

According to Patrick Chun, M.D., Amphivena vice president of clinical development, “T cell engagement has proven to be a viable immunotherapeutic strategy in cancer. However, previous technologies have been limited by toxicity (CRS), exposure, and attenuated efficacy. With this data, we are clearly differentiating Amphivena from other companies in the space. Our unique approach uses T cell engagers that target MDSCs, thus attenuating the immunosuppressive milieu in cancer patients, while simultaneously limiting CRS, which has been the primary adverse event of concern with this class of molecules. Based on the clinical safety and pharmacokinetic profiles, along with clinical activity, we believe it is imperative to further explore AMV564 in selected solid tumor indications and alternative dosing regimens, including once weekly dosing.”

The poster presents data that AMV564 induced expansion of tumor-specific T-cell clones and clinical responses when administered as a monotherapy and in combination with a checkpoint inhibitor, including in patients who have previously progressed with checkpoint inhibitor treatment. Strong induction of IFNγ was observed with monotherapy and especially in combination, with comparatively low IL6, favorable with respect to both safety and induction of anti-tumor response pathways.

The Phase 1 dose escalation study (NCT04128423) enrolled 30 patients (20 monotherapy, 10 combination therapy). The majority of patients received three or more lines of prior therapy (70% of monotherapy patients, 50% of combination therapy patients) including 35% of monotherapy patients and 10% of combination therapy patients who received prior checkpoint-inhibitor therapy.

Details of the Presentations:

  • Title: Results of a phase 1 dose-escalation study of AMV564, a novel T-cell engager, alone and in combination with pembrolizumab in patients with relapsed/refractory solid tumors
  • Authors: Niharika B. Mettu, et al.
  • Abstract Number: 2555

The full abstract and poster will be available on the ASCO Annual Meeting 2021 and Amphivena website ( as of 9:00AM EDT on Friday, June 4th.

About AMV564
AMV564 is a product of Amphivena’s proprietary ReSTORE™ (Relieve Suppression of T cells in Oncology and Reinvigorate Effectors) platform of bivalent T-cell engagers. The investigational drug candidate has been shown to relieve immune suppression via targeted depletion of immunosuppressive MDSC and drive 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, 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 ReSTORE™ (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 take 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.

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