Immune checkpoint + microbiome! Bristol Myers Squibb and Vedanta launched the first human study to evaluate the treatment of multiple cancers with opdivo / ve800

December 29, 2019 news / BIOON / -- Vedanta Biosciences is a clinical stage microbiome company, focusing on the development of a new type of therapy based on a reasonably designed human bacterial combination for the treatment of immune-mediated diseases Recently, the company announced that it has launched the first human clinical study of microbiome therapy ve800 to evaluate the combination of this therapy and opdivo (odivo, common name: nivolumab, nevulizumab), an anti PD-1 therapy of BMS, for the treatment of selected types of advanced or metastatic cancer patients It is worth mentioning that this is the first clinical study of a reasonably defined bacterial combination The company also announced the establishment of the scientific advisory board on immunooncology (SAB), which is composed of experts in the fields of immunology, immunooncology and microbiology, with the aim of supporting the planned clinical development of ve800 Vedanta and BMS entered into a clinical collaboration in December 2018 to develop a ve800 + opdivo combination for multiple types of advanced or metastatic cancer In addition to other parameters, the safety, tolerability and clinical activity of the combination of ve800 and opdivo will be evaluated with the confirmed overall response rate (ORR) In this open, nonrandomized study, more than 100 patients with advanced or metastatic melanoma, gastric / gastroesophageal junction adenocarcinoma, or microsatellite stability (MSS) colorectal cancer were enrolled In the study, eligible patients will receive daily ve800 administration combined with opdivo, and the study is expected to achieve top line results by 2021 Dr Bernat Olle, co-founder and CEO of Vedanta Biosciences, said: "despite the unprecedented global investment in checkpoint inhibitors, different approaches are needed to further enhance and expand the response to cancer Previous approaches have overlooked the role of gut microbiota in the response to immunotherapy, so we're excited about the potential of microbiota regulation to open up new approaches to cancer treatment " Opdivo belongs to PD - (L) 1 tumor immunotherapy, which aims to use the human body's own immune system to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat various types of tumors So far, opdivo has been approved for a variety of cancer indications Ve800 is a kind of human bacterial combination constructed by reasonable design It is a proprietary oral immunooncology candidate product, which is produced by pure and non pathogenic clone bacterial cell bank These clone bacterial cell bank produce standardized powdery drug products Ve800 is composed of 11 symbiotic bacterial strains, which jointly activate cytotoxic CD8 + T cells, which is the pioneer of immune system response to tumor and the key driver of effective immunotherapy In preclinical studies, ve800 has been shown to enhance the ability of these T cells to infiltrate tumors, thereby promoting tumor growth inhibition and improving survival Preclinical data also suggest that ve800 may enhance the effect of immunosuppressive checkpoint inhibitors Vedanta and his co-founder of science, Dr Kenya Honda, medical school of Keio University, Japan, published a basic work in the journal Nature, showing the new antitumor activity of ve800 and its synergistic enhanced response to checkpoint inhibitor therapy and various immune challenges The study also showed that when ve800 was used in combination with PD-1 or CTLA4 immunocheckpoint inhibitors, ve800 showed enhanced therapeutic effect in a series of tumor models Vedanta is committed to developing a class of innovative drugs that can regulate the interaction between human microbiome and immune system Using its unique technology platform, Vedanta company not only isolated a lot of symbiotic strains in human intestinal tract, but also clarified the response of human immune system to these strains Some strains can inhibit the immune response of human body, and they may be used to treat autoimmune diseases, such as inflammatory bowel disease Other strains can stimulate the body's immune response, which may help the body make a stronger fight against infection or cancer At present, Vedanta company has cultivated one of the largest and most diversified intestinal symbiotic bacteria cultures in the world Through the pharmacology related characteristics of different strains, such as the ability to induce different types of immune responses, we can reasonably combine different strains, and use proprietary bioinformatics tools and mathematical modeling to understand how to optimize the combination of strains Vedanta's goal is to develop innovative drugs related to infectious diseases, inflammation, immune tolerance and immunooncology Different from the method of microbiome regulation with metabolites derived from a single strain or microbiome, Vedanta's human bacterial combination therapy aims to make stable and lasting treatment changes to the intestinal microbiome of patients Unlike fecal transplantation or the use of fecal components, human bacterial combination therapy has a clear composition produced from pure clone banks, bypassing fecal donor materials that need to rely on direct sources and are inconsistent in composition In preclinical and clinical studies, this kind of human bacterial combination as a new therapy is safe and well tolerated, and has good pharmacokinetics and pharmacodynamics in human body Vedanta developed the human bacterial combination therapy, which was administered in the form of oral capsules of freeze-dried bacterial powder After oral administration, the living bacteria move along the gastrointestinal tract and are colonized in the gut, stimulating a series of immune responses, including immunoregulatory responses (with potential to treat autoimmune and allergic diseases) and immune enhancement responses (with potential for cancer and vaccination) By rationally selecting and synthesizing different strains, Vedanta aims to develop innovative drugs related to infectious diseases, inflammation, immune tolerance and immunooncology In addition to Bristol Myers Squibb, Vedanta has reached a $390 million cooperation agreement with Johnson & Johnson's Janssen biotechnology company In November 2018, Janssen and Vedanta announced the launch of the first phase I clinical study to explore the potential of oral based, live microbiome therapy ve202 in the treatment of inflammatory bowel disease (IBS) The launch of the study triggered a $12 million milestone payment from Janssen to Vedanta Vedanta Biosciences announcements initiation of first in patient study of immunology candidate ve800 in combination with Bristol Myers Squibb's opera? (nivolumab)