uBiome Announces First Stage of CDx Development in Collaboration w/ Puma Biotechnology
SAN FRANCISCO, Dec. 4, 2018 /PRNewswire-PRWeb/ -- uBiome, the leader in microbial genomics, today announced the first stage of companion diagnostic development with Puma Biotechnology, Inc. (NASDAQ: PBYI) to investigate the role of the microbiome in adverse events related to neratinib treatment of patients with HER2-positive breast cancer.
"This companion diagnostic and clinical trial work is an important part of the future of uBiome," said Dr. Jessica Richman, Ph.D., Co-Founder and CEO of uBiome. "The microbiome is key to absorption of many drugs and also to the success of clinical trials in a variety of settings. Our microbiome data – the largest human microbiome dataset in the world – can be an integral part of clinical trials. This collaboration is the first step in making this future a reality."
Puma Biotechnology's Phase II study will investigate the incidence and severity of diarrhea in HER2-positive breast cancer patients treated with neratinib, in patients who have previously undergone a course of trastuzumab in the adjuvant setting. HER2-positive represents about 20 percent of all breast cancers and is more aggressive and more likely to reoccur than HER2-negative breast cancer. During the trial, samples collected will be processed with uBiome's clinical tests to analyze the role of the microbiome related to neratinib treatment for HER2 positive breast cancer patients.
"This represents a very important milestone for uBiome and the microbiome field as a whole," said Orli Kadoch, uBiome's VP of Business Development, who led the deal. "uBiome hopes to accelerate discovery in this space with future collaborators and continue to drive more effective innovation in drug development, improving treatment efficacy and limiting adverse events through our knowledge of the field."
Founded in 2012, uBiome is the leader in microbial genomics. The Company's mission is to advance the science of the microbiome and make it useful to people. uBiome combines its patented proprietary precision sequencing™ with machine learning and artificial intelligence to develop wellness products, clinical tests, and therapeutics.
uBiome's commercial products include SmartGut™, the world's first sequencing-based clinical microbiome test, which identifies microbes in the gut for patients with chronic gut conditions such as IBD, IBS, Crohn's Disease, and ulcerative colitis; SmartJane™, the first sequencing-based women's health screening test, which genotypes all 19 clinically relevant strains of HPV, identifies four common STDs, and surveys more than 20 vaginal microbes associated with bacterial vaginosis and other conditions; and Explorer™, a health and wellness product to understand the role that food and lifestyle can play in wellness.
uBiome's platform has been used by hundreds of thousands of consumers, patients, and doctors and more than 200 research institutions around the world, including the US Centers for Disease Control (CDC), US National Institutes of Health (NIH), Harvard University, Stanford University, the Massachusetts Institute of Technology (MIT), University of California, San Francisco, Oxford University, and the University of Sydney. Since its launch, the company has received widespread recognition including CNN 10: Startups to Watch, the IVY Technology Award, CNN Future 30, and was named one of Fast Company's Most Innovative Companies in Healthcare in 2016 and in Data Science in 2018, as well as a Technology Pioneer from the World Economic Forum in 2018. For more information, visit http://www.uBiome.com.