VE800 is an orally administered, rationally-designed, defined bacterial consortium immuno-oncology candidate. VE800 consists of 11 clonal human commensal bacteria strains manufactured under cGMP conditions and selected for their ability to induce CD8+ T cells, potentiate the immune system’s attack of tumors and enhance the effects of checkpoint inhibitors. It is produced from pure, non-pathogenic clonal bacterial cell banks, which yield a standardized drug product in powdered form. The seminal work conducted by Vedanta and its scientific co-founder, Dr. Kenya Honda, underlying the discovery of VE800 was published in Nature (Tanoue et al. 2019).

VE800 was evaluated in a first-in-patient clinical trial in combination with Bristol-Myers Squibb’s checkpoint inhibitor OPDIVO® (nivolumab) in patients with selected types of advanced or metastatic cancer. VE800 was evaluated in a first-in-patient clinical trial in combination with Bristol-Myers Squibb’s checkpoint inhibitor OPDIVO® (nivolumab) in patients with selected types of advanced or metastatic cancer. While VE800 demonstrated an acceptable safety and tolerability profile, the observed response rates did not meet the prespecified criteria to expand into the next stage of the study.

Vedanta is analyzing blood, stool, and tumor samples from patients in whom response or disease control was observed, to profile patient subtypes that might benefit from microbiome manipulation. The results of this analysis will inform the next steps for the VE800 program.