Seres Therapeutics Inc（MCRB）资讯与事件MCRBSeres Therapeutics Inc

Seres Therapeutics Announces SER-155 Clinical Trial Results

Seres Therapeutics announced top-line results from an investigator-sponsored trial evaluating SER-155 in patients with irEC. The study, conducted at MSK, evaluated SER-155 in 15 patients with moderate-to-severe irEC, which affects approximately 25% of all immune checkpoint inhibitor therapy recipients in the U.S. Clinical guidelines for these patients stipulate halting of ICI cancer treatment and initiation of systemic immunosuppressive corticosteroids, which are associated with clinically meaningful toxicities and other negative consequences, including: systemic immunosuppression, increased infection risk, metabolic complications, and potential interference with cancer treatment. There remains a significant unmet need for systemic immunosuppressive-free therapeutic approaches that reduce gastrointestinal inflammation and diarrhea and may allow patients who develop irEC to avoid disruption of their life-saving ICI cancer treatment. Participants in the study were on a wide range of ICI types, including PD-1 inhibitors, PD-L1 inhibitors, CTLA-4 inhibitors, LAG-3 inhibitor, and combinations thereof. The promising study results support continued development of SER-155 to treat irEC. Following SER-155 dosing, 12 of 15 participants achieved an immunosuppressive-free clinical response at Day 15, the primary endpoint, defined as at least a 1-grade improvement in diarrhea symptoms without immunosuppressive therapy. Notably, 8 of these 12 responders achieved greater than or equal to a 2-grade improvement in diarrhea symptoms without immunosuppressive therapy at Day 15. At Day 15, 5 of 15 participants achieved immunosuppressive-free complete clinical remission, defined as total resolution of diarrhea symptoms to Grade 0, without immunosuppressive therapy. At Day 43, 5 of 15 participants maintained immunosuppressive-free clinical response, and, notably, 2 of 15 participants maintained immunosuppressive-free complete clinical remission. All 12 participants with immunosuppressive-free clinical response at Day 15 had the same, or better, diarrhea grade at Day 43. As noted, 5 maintained immunosuppressive-free clinical response at Day 43. The other seven were treated with non-systemically acting, gastrointestinal-targeted immunosuppressives after Day 15. SER-155 was generally well tolerated through Day 43, with no safety concerns identified, consistent with the outcome in Seres' Phase 1b study of SER-155 in participants undergoing allogeneic hematopoietic cell transplantation. There were no serious adverse events assessed as related to SER-155 and no bloodstream infections reported in the study through Day 43. Two participants experienced 2 non-serious adverse events each, assessed as possibly related to vancomycin and SER-155. All 4 adverse events were moderate in severity and were resolved. SER-155 bacterial strain engraftment was robust, with the majority of SER-155 strains observed across the study participants, and with kinetics, magnitude, and durability comparable to that observed in prior Seres clinical studies. Translational biomarkers of gastrointestinal inflammation and of mucosal epithelial barrier integrity, which were elevated in participants at baseline, prior to SER-155 dosing, both showed decreases post SER-155 treatment, with statistically significant reductions achieved by Day 43, reflecting improvement in two mechanistically linked dimensions of irEC disease. Data suggest that administration of SER-155 led to improvement in mucosal epithelial barrier integrity, providing support for potential further development in multiple other inflammatory and immune diseases.

Seres Therapeutics Secures $25M from Nestle Health Science

Seres Therapeutics announced two transactions to extend its expected operating cash runway well into the first quarter of 2027. Seres entered into an amendment to the prior asset purchase agreement whereby Nestle Health Science will now pay Seres a total of $25M to buy out potential future Vowst net sales-based milestones, and a restructured lease agreement for one of Seres' locations which materially reduces the company's leased space and ongoing annual facility cash costs and long-term lease obligations. Seres previously developed Vowst, the first orally administered microbiome-based therapeutic approved by the FDA for the prevention of recurrence of Clostridioides difficile infection in adults following antibacterial treatment for recurrent CDI. Seres sold the Vowst business to Nestle Health Science in 2024. As of March 31, Seres had $29.8M in cash and cash equivalents. Based on the transactions described herein and current operating plans, Seres expects to fund operations well into the first quarter of 2027. This projection excludes proceeds from any potential future partnerships or other sources of capital. Seres sold its interest in the Vowst business to Nestle Health Science in 2024. Seres has entered into an amendment to the asset purchase agreement whereby Nestle Health Science will pay Seres an aggregate of $25M, in two installments of $12.5M each on July 1 and October 1 to buy-out the potential future milestones due to Seres if and upon the achievement of certain Vowst net sales targets. Seres has amended its lease with its landlord for the company's facility at 101 CambridgePark Drive in Cambridge, Massachusetts, reducing its leased space, rental rate and facility operating expenses. Under the amended arrangement, Seres will lease the retained space for a 10-year term at market-adjusted annual rent and a lower percentage of shared operating expenses for the building as of May 1 in exchange for the landlord drawing the existing letter of credit, Seres payment of a termination fee and the establishment of a new letter of credit. The restructured lease is expected to materially reduce the company's ongoing annual facility-related costs and long-term obligations. Additional details regarding the Nestle Health Science asset purchase agreement amendment and the lease amendment are included in the company's current report on Form 8-K which will be filed with the Securities and Exchange Commission.