Novel Approaches for Better Patient Responses with Immunotherapy: Seres Therapeutics

Opportunity

When one of our investigators has a promising idea, our goal is to make it a reality. But we can’t do it alone. We turn to the right industry partners to support our research – from pre-clinical studies to clinical trials. Jennifer Wargo, MD, and a group of PICI researchers at MD Anderson Cancer Center published a study in Science in November 2017 showing an interesting discovery: melanoma patients with certain types of gut bacteria and a more diverse gut microbiome overall respond better to checkpoint inhibitors. This breakthrough had potential to improve patient outcomes. We sought out the best partner to help us test this hypothesis. Seres Therapeutics, an industry leader in the microbiome revolution, joined PICI and MD Anderson to conduct a clinical trial (MCGRAW) to better understand how the microbiome affects patient responses to immunotherapy with the goal of improving treatments for more patients.

How It Works

To bring the trial to life in the shortest time possible, we combined the expertise from each partner to launch it within a year of the initial research publication. We brought in the top researchers in the field, along with our expertise in clinical trial management and regulatory affairs. MD Anderson brought deep knowledge of the microbiome’s connection to cancer immunotherapy. And Seres brought expertise on the microbiome, extensive patient data, and the technology and manufacturing expertise to develop microbiome therapies.

In this trial, melanoma patients take either a placebo or an oral microbiome therapy enriched with strains of microbes found to be associated with an antitumor response to checkpoint inhibitor treatment. We will sequence the gut microbiome of all patients before and during treatment with checkpoint inhibitors to record the types and amounts of microbes present and to determine if microbiome administration can change the makeup of the patients’ gut microbiomes. We will also track changes of the patients’ immune systems over time.

This novel therapeutic candidate could increase the number of cancer patients who benefit from checkpoint inhibitors. Working together, we translated this research into treatments for patients much faster than any of us could on our own.

Looking Forward

In this first-of-its-kind clinical trial, we aim to show that changing the microbiome in cancer patients can improve response to checkpoint inhibitor treatments and improve the immune system. This breakthrough could be a key milestone for the entire field. And this project is a model we want to replicate – to engage other industry pioneers to help us realize our investigator’s work and get research into the clinic as quickly as possible.