Biomarkers and bowel disease

The companies have agreed that Second Genome will leverage its proprietary Microbiome Analytics Platform to identify novel biomarkers associated with clinical response to Gilead’s investigational drug candidates. Second Genome will also apply the platform to identify up to five novel IBD targets or drug candidates over the next four years, with an option for a two-year extension of the collaboration.

Per the terms of the agreement, Gilead will pay Second Genome $38 million in an upfront payment, with the potential for up to approximately $300 million in success-based preclinical, clinical, regulatory and commercial milestones for each of the five programs. Second Genome will also be eligible for success-based milestones for each validated biomarker delivered under the deal, as well as eligible for low double-digit royalties for any approved products. Gilead will hold an option to the worldwide rights for up to five programs for all diseases, and exclusive rights to all biomarkers developed under this agreement.

Linda Higgins, Gilead's senior vice president, Research External Innovation, tells DDNews that Second Genome was selected as “a partner that would bring deep expertise in microbiome research,” adding that “Second Genome is a leader in microbiome science and brings expertise that enhances our efforts to bring forward transformative new therapies. Using their proprietary Microbiome Analytics Platform, together we hope to harness the latest insights in microbiome science to inform patient stratification and optimize the development of future treatments.”

“There is a growing body of evidence that the microbiome plays an important role in disease progression and treatment response in inflammatory diseases,” remarked Dr. William Lee, executive vice president of research at Gilead. “We look forward to working with Second Genome to investigate the microbiome’s role in inflammatory disease and particularly IBD, where patients can face significant challenges in achieving long-term remission with conventional therapies. This collaboration is the latest example of Gilead’s ongoing commitment to advance research in inflammatory diseases, combining external innovation and insights from Second Genome with our own expertise, as we work to bring forward transformative therapies to improve patient outcomes.”

Second Genome’s platform features “a robust portfolio of best-in-class microbiome profiling and bioinformatics analytic technologies for discovering and elucidating the function of microbes in disease,” according to the company’s website. Second Genome notes that it is the only research platform that applies the PhyloChip assay, which was developed at the Lawrence Berkeley National Laboratory and provides “detailed measurements of microbial community dynamics in a high-throughput, reproducible manner.”

“The Second Genome platform seeks to redefine diseases through the lens of the microbiome, utilizing this incredible resource to identify potential biomarkers and therapeutics,” said Dr. Karim Dabbagh, CEO of Second Genome. “We believe the microbiome holds insight into patient heterogeneity as well as response to specific therapies. These differences enable the identification of important biomarkers to enhance precision medicine for better patient segmentation as well as potential combination therapies. We are excited to be collaborating with Gilead using these approaches in IBD for new biomarkers as well as target and drug candidate discovery, driving toward improved clinical outcomes for patients.”

In other recent news, Gilead announced that it had completed its acquisition of Forty Seven Inc. the same week it launched its deal with Second Genome. The company was acquired by Toro Merger Sub Inc., Gilead’s wholly owned subsidiary, for $95.50 per share, net to the seller in cash, for an aggregate total of approximately $4.9 billion. Gilead and Forty Seven signed a definitive merger agreement in March for this transaction, to be followed by a tender offer.

Forty Seven is a clinical-stage immuno-oncology company advancing immunotherapies against CD47 and other targets in the fight against cancer. The company was founded in 2015, and has collaborated with other big pharma partners such as Merck KGaA, Lilly and Genentech, a member of the Roche Group.

“The Forty Seven integration supports our strategic focus in growing our pipeline and expertise in immuno-oncology. Forty Seven’s investigational lead product candidate, magrolimab, is a potential first-in-class, clinical-stage therapeutic that targets an innate immune mechanism which we believe may bring significant benefit to patients with certain hematological malignancies,” Higgins notes. “This acquisition strengthens our immuno-oncology research and development portfolio and helps bring us closer to our goal of introducing 10 transformative therapies over the next 10 years.”