NEO-201

P1/2, N=121, Recruiting, Precision Biologics, Inc | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025

Conclusion. Expression of NEO-201 is not found in blasts, immature cells, and monocytes of the analyzed patients, contrary a CD15+ neutrophil granulocytes where NEO-201 is positive, supporting the proposal to integrate NEO-201 as a marker in the differential diagnosis, leaving open the possibility of use as a future antitumor agent.

Expression of NEO-201 is not found in blasts, immature cells, and monocytes of the analyzed patients, contrary a CD15+ neutrophil granulocytes where NEO-201 is positive, supporting the proposal to integrate NEO-201 as amarker in the differential diagnosis between AML and MDS and in monitoring the course of patients, leaving open the possibility of use as a future antitumor agent. Flow cytometry, Monoclonal antibody, Myelodysplastic syndrome, Acute myeloid leukemia

This study demonstrated that NEO-201 can be used to identify and kill suppressive gMDSCs in addition to Treg cells. Depletion of suppressive Tregs and gMDSCs in the TME could be an effective strategy to prevent hyperprogressive disease when anti-PD-1 is used in cancer immunotherapy. These data support the rationale for the ongoing phase II clinical trial using NEO-201 in combination with pembrolizumab in checkpoint refractory patients with metastatic solid tumors.

These results demonstrated that NEO-201 binds to core 1 and extended core 1 O-glycans expressed in its target cells. Since GalNAc residue can be added onto threonine and serine to form O-glycans, it is very likely that NEO-201 recognizes these O-glycans attached to any protein with amino acid regions containing serine and threonine.

In addition, preclinical studies have demonstrated that NEO-201 can bind to human regulatory T (Treg) cells. The specificity of NEO-201 in recognizing suppressive Treg cells provides the basis for combination cancer immunotherapy with checkpoint inhibitors targeting the PD-1/PD-L1 pathway.

P1/2, N=121, Recruiting, Precision Biologics, Inc | Phase classification: P1 --> P1/2 | N=35 --> 121

Materials & Various human tumor cell lines were used as target cells and NK-92 cells (CEACAM1+/CD16-) were used as effectors to assess the ability of NEO-201 to block the interaction between CEACAM5 on tumor cells and CEACAM1 on NK cells in order to enhance the in vitro killing of tumor cells. This study demonstrates NEO-201 can block the interaction between tumor cell CEACAM5 and NK cell CEACAM1 to reverse CEACAM1-dependent inhibition of NK killing. NEO-201 can also target and eliminate human immunosuppressive regulatory T cells (Tregs).

High expression of activating markers and low expression of CEACAM1 on CD56+/CD16+ NK cells, as well as low levels of sMICA and sCEACAM5 correlate with clinical response to NEO-201. Thus, the activity of NK cells may serve as predictors for efficacy of tumor-targeting antibody therapy. Further correlation of these biomarkers with PK and CEACAM1/5/6 expression in patients’ tissue samples will provide further support for optimizing the use of NEO201.