Go with your gut

CAMBRIDGE, Mass.—Seres Therapeutics Inc. is going into the end of Q1 2019 with good news, having announced a three-year research collaboration with industry giant AstraZeneca. Seres is a microbiome therapeutics platform company seeking to develop biological drugs that treat disease by restoring dysbiotic microbiomes in which “the state of bacterial diversity and function is imbalanced,” the company states. And the microbiome is the focus of this new collaboration.

Seres and AstraZeneca will be exploring the potential of microbiome-based approaches to determine which patients could respond best to certain cancer immunotherapies. The partners will also explore whether microbiome therapy could improve patients' clinical response when combined with adjunctive pharmaceutical regimens. Preclinical work and some early results from clinical study seem to show that the makeup of an individual's gastrointestinal microbiome affects how they respond to checkpoint inhibitor immunotherapy, and that modifying that microbiome could improve patient response.

“Our new collaboration with Seres Therapeutics represents an important opportunity to advance our understanding of the relationship between the microbiome and the immune system’s ability to respond to cancer therapy,” said Dr. Jean-Charles Soria, senior vice president, Research & Development Oncology at AstraZeneca. “Despite progress in the field of immunotherapy, we are only at the tip of the iceberg. Too many patients are still unable to benefit from existing therapies, so we must continue following the science in pursuit of new and innovative solutions.”

Per the terms of the agreement, AstraZeneca will pay Seres $20 million in three equal installments over two years, with the first payment due once the collaboration begins. Seres will also be reimbursed for research activity related to this agreement. While Seres will maintain rights to cancer-targeted microbiome therapeutic candidates, AstraZeneca will have the option to negotiate for rights to those programs and other inventions that result from this collaboration.

Seres and AstraZeneca may also explore the combination of AstraZeneca oncology compounds and SER-401, an oral microbiome therapeutic candidate derived from healthy individuals identified as having a microbiome bacterial signature similar to those seen in patients who respond to cancer immunotherapy. The compound is intended to modify cancer patients' microbiome to boost their response to immunotherapy, and it is currently under evaluation in a Phase 1b clinical study in metastatic melanoma.

“We are very pleased to be collaborating with AstraZeneca, a global leader in oncology, to advance the development of potential microbiome-based therapies for cancer. Through the activities under this collaboration and in our SER-401 Phase 1b clinical study in metastatic melanoma, we hope to meaningfully advance our understanding of the potential for microbiome therapeutics to magnify the impact of cancer immunotherapy,” commented Eric Shaff, president and CEO of Seres Therapeutics.

Motley Fool's Cory Renauer noted that Seres Therapeutic's shares rose 64 percent following news of the AstraZeneca deal.

“The partners aren't beginning any studies right away. That's because AstraZeneca's probably waiting to see if patients given Opdivo plus SER-401 outperform those given Opdivo on its own,” Renauer said, pointing out that AstraZeneca has Imfinzi (durvalumab), a cancer immunotherapy that is similar to Opdivo and could explain the company's interest in the results of the trial.

He added that “To a company as large as AstraZeneca, $20 million is pretty small potatoes. That said, I wouldn't be surprised if a sneak peek at results from a highly anticipated presentation coming up at the end of the month played a role.”

The trial of SER-401 in question is being conducted by the Parker Institute for Cancer Immunotherapy, in partnership with the University of Texas MD Anderson Cancer Center. The trial consists of 30 patients diagnosed with metastatic melanoma who will receive either SER-401 and Opdivo, or Opdivo plus a placebo.

“On March 31, at the annual meeting of the American Association for Cancer Research (AACR), we'll find out if fecal transplants from patients who respond well to anti-PD-1 therapy help patients who didn't respond the first time around. Seres is developing feces-free treatments that patients swallow, but the goal is the same as a fecal transplant. If results suggest the right microbiome really makes a difference, this stock could jump again,” noted Renauer.