The University of Texas MD Anderson Cancer Center and Federation Bio today announced a strategic collaboration to design and manufacture a complex, synthetic microbial consortium with the goal of expanding the number of cancer patients who respond to immunotherapy. The agreement pairs Federation Bio’s proprietary ACT™ (anerobic co-culture technology) platform with the expertise and capabilities of MD Anderson’s Platform for Innovative Microbiome and Translational Research (PRIME-TR).

Immune checkpoint inhibitors and other forms of immunotherapy have dramatically improved outcomes for many with cancer, but many patients do not benefit from these treatments. Previous work, including research led by MD Anderson, demonstrates the gut microbiome is a key mediator of individual response to checkpoint inhibitors. Further, early findings suggest that fecal microbiota transplants (FMT) from individuals who respond to checkpoint inhibitors may improve outcomes for those who did not previously benefit. Unfortunately, the application of FMT in this setting has been hindered by the inability to scale up manufacturing or modify FMT for enhanced therapeutic benefit.

Under the agreement, MD Anderson and Federation Bio intend to rationally design a complex consortium of bacteria derived from a donor fecal sample that has a demonstrated ability to improve immunotherapy responses in cancer patients via FMT in a clinical trial. Federation Bio will use its proprietary ACTTM platform to manufacture the consortium from purified cell lines, generating a therapy that comprises the full metabolic complexity of the identified microbiome and is optimized for therapeutic benefit.

“Federation Bio’s demonstrated ability to engineer complex, synthetic bacterial consortia and produce them at scale offers an exciting avenue to potentially improve cancer immunotherapy responses,” said Jennifer Wargo, M.D., professor of Genomic Medicine and Surgical Oncology and director of PRIME-TR at MD Anderson. “Published evidence supports the potential of this approach, and we believe this collaboration will enable us to accelerate the development and evaluation of microbial cell therapies for our patients.”

Federation Bio’s ACTTM platform uniquely enables the production of highly controlled bacterial consortia that have been rationally designed to address a broad range of diseases and disorders. The company already has used the platform to design and manufacture FB-001, an investigational oral therapy consisting of 148 bacterial strains isolated from multiple healthy donors. Federation Bio currently is evaluating FB-001 in a Phase I clinical trial; it is the first rationally designed complex consortium at this scale to enter clinical studies.

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