CAMBRIDGE, Mass.–Seres Therapeutics, Inc. (NASDAQ:MCRB), The University of Texas MD Anderson Cancer Center (MD Anderson), and the Parker Institute for Cancer Immunotherapy (Parker Institute) today announced a collaboration to evaluate the potential of Seres’ microbiome therapies to improve the outcomes of cancer patients treated with currently-available immunotherapy.
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.”
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
About Seres Therapeutics
Seres Therapeutics, Inc., is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres’ clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary C. difficile infection. For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 47 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report's “Best Hospitals” survey. It has ranked as one of the nation's top two hospitals for cancer care since the survey began in 1990, and has ranked first 13 times in the last 16 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
About the Parker Institute for Cancer Immunotherapy
The Parker Institute for Cancer Immunotherapy brings together the best scientists, clinicians and industry partners to build a smarter and more coordinated cancer immunotherapy research effort.
The Parker Institute is an unprecedented collaboration between the country’s leading immunologists and cancer centers. The program started by providing institutional support to six academic centers, including Memorial Sloan Kettering Cancer Center, Stanford Medicine, the University of California, Los Angeles, the University of California, San Francisco, the University of Pennsylvania and The University of Texas MD Anderson Cancer Center. Recently, the institute also initiated programmatic support for top immunotherapy investigators, including a group of researchers at Dana-Farber Cancer Institute, Robert Schreiber, Ph.D., of Washington University School of Medicine in St. Louis, Nina Bhardwaj, M.D., Ph.D., of the Icahn School of Medicine at Mount Sinai and Phil Greenberg, M.D., of the Fred Hutchinson Cancer Research Center.
The goal is to accelerate the development of breakthrough immune therapies capable of turning most cancers into curable diseases. The institute was created through a $250 million grant from The Parker Foundation.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the initiation of a clinical trial, benefits associated with microbiome therapeutics, and the impact of the microbiome on checkpoint inhibitor response.
These forward-looking statements are based on Seres’ management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Seres has incurred significant losses and may never become profitable; Seres’ need for additional funding; Seres’ limited operating history; Seres’ unproven approach to therapeutic intervention; the lengthy and expensive process of clinical drug development; Seres’ lack of experience in manufacturing, selling, marketing, and distributing its product candidates; failure to compete successfully against other drug companies; protection of Seres’ proprietary technology and the confidentiality of Seres’ trade secrets; potential lawsuits or claims for infringement of third-party intellectual property or challenging the ownership of Seres’ intellectual property; Seres’ patents being found invalid or unenforceable; risks associated with international operations and marketing; the potential volatility of Seres’ common; Seres’ executive officers, directors, and principal stockholders have the ability to control all matters submitted to the stockholders; and Seres is currently subject to securities class action litigation. These and other important factors discussed under the caption “Risk Factors” in Seres’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 8, 2017 and Seres’ other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent Seres’ management’s estimates as of the date of this press release. While Seres may elect to update such forward-looking statements at some point in the future, Seres disclaims any obligation to do so, even if subsequent events cause Seres’ management’s views to change. These forward-looking statements should not be relied upon as representing Seres’ views as of any date subsequent to the date of this press release.
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