– AMV564, a novel first-in-class agent that depletes MDSC and activates T cells, is being investigated in a Phase 1 clinical trial in advanced solid tumors

– Updated monotherapy dose escalation data demonstrate safety and preliminary efficacy of subcutaneously administered AMV564

– Phase 1 data support dose and schedule of AMV564 for expansion cohorts in selected solid tumor indications

– Treatment with AMV564 results in reductions in immunosuppressive MDSC and significant increases in effector CD8+ T cells and CD4+ Th1 cells, and expansion of the T cell repertoire in patients, consistent with restoration of anti-cancer immunity.

SOUTH SAN FRANCISCO, CA, USA I November 9, 2020 I Amphivena Therapeutics, a clinical-stage oncology company focused on developing immunotherapeutics that restore anti-cancer immunity in patients, today present updated clinical and translational data for the lead clinical candidate, AMV564, from the Amphivena ReSTORETM (Relieve Suppression of T cells in Oncology and Reinvigorate Effectors) platform of bivalent T-cell engagers, in two poster presentations at the SITC Annual Meeting being held virtually from November 9-14, 2020. 

The Phase 1 dose escalation study (NCT04128423) enrolled 16 advanced solid tumor patients into the monotherapy cohort at the time of data cut off.  The majority (62.5%) of patients received 3 or more lines of prior therapy while 31% of patients received prior checkpoint-inhibitor therapy.  AMV564 continues to be well tolerated with no dose-limiting toxicities reported.  Based on the safety, PK profile and clinical activity including a confirmed RECIST complete response in an ovarian cancer patient, AMV564 will be further explored in selected solid tumor indications.

Assessment of the pharmacodynamic effects in solid tumor patients using patient blood samples demonstrates that AMV564 potently depletes immunosuppressive MDSC and increases both effector CD8+ and CD4+ Th1 T cells in patients.  Correlative to increases in effector CD8+ T cells, expansion of the T cell repertoire was apparent with ≥1 cycle of AMV564 treatment.  Consistent with findings from patients, in vitro analyses confirm that AMV564 is highly selective for MDSC and does not target differentiated monocytes or neutrophils.  AMV564 can also elicit T-cell mediated killing of MDSC utilizing different T cell subsets (CD4+, CD8+ and naïve CD8).

Details of the Presentations:

Poster Title:   Single-agent anti-tumor activity in relapsed/refractory solid tumors: interim data from the Phase
1 solid tumor trial of AMV564, a novel T-cell engager
Presenter:       Sarina Piha-Paul M.D.
Poster Number: 372
Poster Q&A:     Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST
Poster Title AMV564, a clinically active T cell engager, induces a target-dependent adaptive immune
Presenter:     Sterling C. Eckard, Ph.D.
Poster Number:   692
Poster Q&A:     Thursday, Nov. 12 from 4:50–5:20 p.m. EST and Saturday, Nov. 14 from 1–1:30 p.m. EST

The full abstracts and posters will be available on the SITC conference and Amphivena websites as of 8:00AM ET on Monday, November 9th.

About AMV564

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.

SOURCE: Amphivena Therapeutics