SOUTH SAN FRANCISCO, Calif.,?May 29, 2020?/PRNewswire/ --

• Initial data from the Phase 1 dose escalation trial in 18 patients with advanced solid tumors shows AMV564 administered subcutaneously was well tolerated, with no dose-limiting toxicities
• AMV564 showed single-agent activity including one complete response in a heavily pre-treated, checkpoint inhibitor-refractory ovarian cancer patient for whom treatment is ongoing
• Clinical development of AMV564 is proceeding to planned expansion cohorts to evaluate AMV564 as a monotherapy and in combination for tumor-specific indications

Amphivena Therapeutics, a clinical-stage immuno-oncology company focused on developing immunotherapeutics that restore anti-cancer immunity to the patient, today presented data from a Phase 1 study of its lead clinical candidate AMV564 in a poster presentation at the ASCO Virtual Annual Meeting.

The Phase 1 dose escalation study (NCT04128423) has enrolled 18 advanced solid tumor patients at the time of data cut off. AMV564 was administered once daily via subcutaneous injection, either alone or in combination with pembrolizumab for 2 weeks out of every 3-week cycle.

AMV564 was well tolerated with no dose-limiting toxicities reported in monotherapy or combination therapy cohorts.? Assessment of the pharmacodynamic effects of AMV564 using patient blood samples at various timepoints demonstrated depletion of myeloid derived suppressor cells (MDSC) and increases in CD8:Treg ratio with AMV564 treatment.

AMV564 demonstrated single-agent activity including one complete response in a patient with heavily pre-treated (including prior checkpoint inhibitor therapy) ovarian cancer, who remains on study after 10 cycles of treatment.? The disease control rates for the monotherapy and combination arms were 45 percent and 29 percent, respectively.

Details of the Presentation:

Title: A Phase 1 Study to Evaluate the T-cell Engager AMV564 Alone and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Authors:?Starodub, A. et al.
Abstract?Number: 3101 (Poster: 165)

The full abstract and poster will be available on?ASCO conference?and?Amphivena websites?as of?8:00AM ET on Friday, May 29^th.

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-function 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.

Contact:
Alicia Chung, Corporate Development
achung@amphivena.com
+1 650 499-3178
info@amphivena.com