All study endpoints were achieved. Safety was established over a wide dose range (3-20 doses of 2.5B cells per patient) and a total of >220 administered doses. No related DLTs, injection site reactions or drug
related serious adverse events were identified throughout the course of the study. Signs of clinical efficacy were demonstrated with a CR and two PRs and a number of long-lasting SD responses in various tumor types
including, CRC-dMMR/MSI-H, ccRCC, melanoma, lung cancer and TNBC.
Based on these positive first-in-human single-agent clinical trial results in select tumor types – supported by laboratory evidence that SUPLEXA cells modulate the immune environment of treated patients – a Phase 2 study of SUPLEXA combined with ICIs in front-line CRC-dMMR/MSI-H patients is under development. Since SUPLEXA possesses APC-like properties, we hypothesize that SUPLEXA cells may facilitate the production and function of anti-tumor primed T cells. Since the mechanism of action for immune checkpoint inhibitors depends on the presence of such primed T cells, we suggest that a combination of SUPLEXA with ICIs may result in synergistic activity with an improvement
in the current 12-month PFS of ~55%.
This Phase 2 study will be open label 2-arm comparing the standard of care ICI against ICI combined with SUPLEXA. The advantage of such a study is that all participants receive ICI standard of care, and as front-line patients are less fragile.
For further information, see accompanying poster, Poster 378, ‘Transcriptional and proteomic insights into the immunomodulatory nature of SUPLEXA cells: An autologous cellular therapy for cancers’