On November 9, 2020 Amphivena Therapeutics, a clinical-stage oncology company focused on developing immunotherapeutics that restore anti-cancer immunity in patients, reported 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 (Free SITC Whitepaper) Annual Meeting being held virtually from November 9-14, 2020 (Press release, Amphivena Therapeutics, NOV 9, 2020, View Source [SID1234570656]).
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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
response
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 (Free SITC Whitepaper) 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).