On November 14, 2017 Seres Therapeutics, Inc. (NASDAQ:MCRB), The University of Texas MD Anderson Cancer Center (MD Anderson), and the Parker Institute for Cancer Immunotherapy (Parker Institute) reported a collaboration to evaluate the potential of Seres’ microbiome therapies to improve the outcomes of cancer patients treated with currently-available immunotherapy (Press release, Seres Therapeutics, NOV 14, 2017, View Source [SID1234530894]).
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The collaborators plan to initiate a randomized, placebo-controlled clinical study at MD Anderson, sponsored by the Parker Institute, in patients with advanced metastatic melanoma. The clinical trial will evaluate the impact of an anti-PD-1 checkpoint inhibitor with adjunctive microbiome therapy on patient outcomes. Seres is developing SER-401, a preclinical stage oral microbiome therapy comprising a rationally-designed consortium of live bacteria, to improve the efficacy and safety of immunotherapy.
Published studies provide preclinical and clinical evidence demonstrating that the composition of bacteria in the gastrointestinal microbiome may impact response to checkpoint inhibitor therapy.1 On Nov. 2, 2017, Science published research by Jennifer Wargo, M.D. and colleagues from MD Anderson indicating that the composition of the gut microbiome may influence checkpoint inhibitor response in melanoma patients.2 This research also demonstrated that the favorable microbiome properties found in checkpoint inhibitor responder patients are able to be transferred to mice. The results provide support for the clinical study of microbiome therapeutics to augment the clinical benefit of cancer immunotherapy.
Seres also received an exclusive option, with pre-defined financial terms, to license intellectual property rights from MD Anderson related to the use of bacteria in combination with checkpoint inhibitors.
"MD Anderson, and in particular Dr. Wargo’s laboratory, is leading the charge to better understand the microbiome and the response to immune checkpoint inhibitors," said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. "We look forward to combining our insights and capabilities with both MD Anderson and the Parker Institute to advance microbiome therapies to augment Immunotherapy in cancer patients toward the clinic, with the ultimate goal of improving outcomes for patients facing life-threatening tumors with significant unmet medical need."
"Immunotherapy has represented an important advance for melanoma and other cancers. However, in the majority of patients, the response is not adequate to durably control disease," said Jennifer Wargo, M.D., Associate Professor of Genomic Medicine and Surgical Oncology at MD Anderson. "Modulation of the microbiome is a promising approach that may improve the therapeutic benefit of checkpoint therapy."
"This collaboration between the Parker Institute, Seres and MD Anderson exemplifies the mission of the Parker Institute for Cancer Immunotherapy to unlock the promise of immunotherapy by rapidly progressing next generation treatments into clinical trials," said Fred Ramsdell, Ph.D., Vice President of Research at the Parker Institute of Cancer Immunotherapy. "If this novel approach is successful at altering the microbiome and more importantly, also leads to better cancer patient responses to immunotherapy, this would mark an important milestone for the entire field."
References
1. Chen C. and Mellman I., Elements of cancer immunotherapy and the cancer-immune set point, Nature, 2017
2. Wargo J. et al., Gut Microbiome Impacts Response to Anti-PD-1 Immunotherapy in Melanoma Patients, Science, 2017