Vedanta’s VE707 microbiome program is designed to accelerate the development of a new category of oral therapeutics to help a patient’s microbiota fight drug-resistant bacteria.
(BOSTON, MA) – CARB-X is awarding Vedanta Biosciences, of Cambridge, MA, USA, up to $5.8 million in non-dilutive funding, with the possibility of $3.5 million more if certain project milestones are met, to develop a new category of oral therapeutics designed to restore a patient’s healthy microbiota so that it can fight multi-drug-resistant bacteria.
The funding will support the development of VE707, Vedanta’s preclinical human microbiome program. VE707 is designed to restore a healthy microbiota as well as prevent infection and colonization recurrence of several multi-drug resistant organisms (MDRO) which are responsible for hundreds of thousands of hospital-acquired infections each year in the United States and Europe. This is the second Vedanta project that has been selected by CARB-X for funding and support.
“The addition of Vedanta’s VE707 program to the CARB-X portfolio expands the rich diversity of our pipeline and reflects a novel approach against drug-resistant bacteria,” said Kevin Outterson, executive director of CARB-X, which is based at the Boston University School of Law. “Innovations such as VE707, if successful and approved for use in patients, could offer physicians broader treatment options that would strengthen a patient’s ability to fight serious infections and limit the spread of drug-resistant bacteria.”
“We are very pleased to partner with CARB-X for a second time and look forward to working with the CARB-X team to develop an alternative to antibiotics to help address the burden of MDRO infections,” said Bernat Olle, PhD, chief executive officer of Vedanta Biosciences. “If we could get rid of intestinal carriage of these MDROs in high risk patients, we could not only prevent infections, but also curb the transmission of these organisms and enable physicians to avoid using antibiotics that select for ever-more resistant bacterial strains.”
Vedanta Biosciences received its first grant from CARB-X for $5.4 million in 2017 to support clinical testing of Vedanta’s oral product candidate, VE303, for the potential treatment of recurrent Clostridioides difficile infection (rCDI). VE303 graduated from the CARB-X portfolio in 2018 and is currently being evaluated in a Phase 2 clinical trial in patients at high risk of rCDI.
VE707 is Vedanta’s preclinical program for the prevention of infection and colonization recurrence of several MDROs. VE707 is designed to be administered orally and consists of a defined consortium of commensal bacteria. It is produced from pure, clonal bacterial cell banks, which yield a product of uniform composition and free of any pathogenic strains, bypassing the need to rely on fecal donor material with inconsistent composition. VE707 is designed to decolonize gut-dwelling multi-drug resistant organisms in patients at high risk for developing infections. Specifically, VE707 is being developed to eliminate intestinal carriage of carbapenem-resistant Enterobacteriaceae (CRE), extended-spectrum beta lactamase producers (ESBL), and vancomycin-resistant Enterococci (VRE) to restore a healthy microbiota as well as prevent infection and colonization recurrence. CRE, ESBL, and VRE infections are some of the most common hospital-acquired infections and are estimated to affect over 500,000 intensive care unit, dialysis, solid organ transplant, and hematopoietic stem cell transplant patients each year in the US and Europe. Infections with these organisms can result in life-threatening treatment delays or death and result in approximately $2 billion healthcare-associated costs due to patient isolation practices alone.
Supporting innovation to address the global rise of drug resistance
CARB-X is investing up to $500 million in antibacterial R&D between 2016-2021. The goal is to support projects through the early phases of development through Phase 1, so that they will attract additional private or public support for further clinical development and approval for use in patients.
The CARB-X portfolio is the world’s largest antibacterial development portfolio with 33 projects in five countries. Since its inception in 2016, CARB-X has announced 52 awards exceeding $160.6 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
The scope of CARB-X funding is restricted to projects that target drug-resistant bacteria highlighted on the Centers for Disease Control and Prevention (CDC)’s 2013 Antibiotic Resistant Threats list, or the Priority Bacterial Pathogens list published by the World Health Organization (WHO) in 2017 – with a priority on those pathogens deemed Serious or Urgent on the CDC list or Critical or High on the WHO list.
According to the WHO, an estimated 700,000 people die each year worldwide from bacterial infections.