VE800 / Vedanta Biosci - LARVOL DELTA

CONSORTIUM-IO: a phase 1 study evaluating a combination of an 11-strain bacterial consortium (VE800) and nivolumab in treatment of select refractory or metastatic cancers (SITC 2024) - P1/2 | "University of Utah IRB, IRB_00128490 University of Pittsburg Medical Center IRB, MOD00655221, Pro00039903 Advarra Center for IRB Intelligence Platform, MOD00655221, MOD0146106, 00000971 WCG Institutional Review Board, Study Numbers: 1282434, 1273387, 1275793, 1283587 New York University School of Medicine Study Number i19-00845 Rhode Island Hospital & Miriam Hospital 204120 University of California Los Angeles, IRB#20--000133-AM00006 Cedars Sinai Samuel Oschin Comprehensive Cancer Institute, CR2019-1002-0 University of Chicago Medical Center, IRB19-1676 Sutter Health IRB, 1549521-7 Weill Cornell Medicine, 20-02021418. Consent The study protocol and informed consent documents were approved by the respective sites' Institutional Review Boards.Download figure Open in new tab Download powerpoint Abstract 607 Figure 1"

IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • TNFA

Consortium-IO: Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=56 | Completed | Sponsor: Vedanta Biosciences, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Feb 2023

Metastases • Trial completion • Trial completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

[VIRTUAL] Consortium-IO: A safety and efficacy study of VE800 in combination with nivolumab in previously treated patients with select advanced metastatic cancers (AACR-I 2020) - P1/2 | "Exploratory endpoints include tumor and blood immunophenotyping, serum/stool metabolomics and global changes in fecal microbiome composition. CONSORTIUM-IO is currently actively enrolling pts."

Clinical • Combination therapy • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

Consortium-IO: Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2; N=54; Active, not recruiting; Sponsor: Vedanta Biosciences, Inc.; Recruiting ➔ Active, not recruiting; N=111 ➔ 54; Trial completion date: Apr 2022 ➔ Jul 2022

Clinical • Enrollment change • Enrollment closed • Trial completion date • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

John Theurer Cancer Center participating in early-phase study of immunotherapy-boosting treatment (PRNewswire) - “Investigators at John Theurer Cancer Center at Hackensack University Medical Center in New Jersey are participating in a first-in-patients clinical trial assessing VE800, a novel bacteria-containing therapy, in combination with the immunotherapy drug nivolumab….The phase I study, which is being conducted at John Theurer Cancer Center and other centers across the United States, will evaluate the safety and clinical activity of VE800 in combination with nivolumab in patients with advanced or metastatic melanoma, gastric/gastroesophageal junction adenocarcinoma (esophagus/stomach cancer), or a type of colon cancer called microsatellite-stable colorectal cancer. The first results are anticipated in 2021.”

Clinical • P1 data

Consortium-IO: Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2; N=111; Recruiting; Sponsor: Vedanta Biosciences, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Newly added product (clinicaltrials.gov) - P2, Oncology, Melanoma

Pipeline update