SER-301 / Seres Therap, Nestle - LARVOL DELTA

Seres Therapeutics Ditches Its SER-301 Phase 1b Second Study In Ulcerative Colitis (Yahoo Finance) - "In its SEC filing, Seres Therapeutics Inc...disclosed it would not move forward with the planned SER-301 Phase 1b second study cohort....The Company plans to continue research activities evaluating ulcerative colitis based on SER-287 and SER-301 trial data."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Seres Announces Preliminary SER-287 Phase 2b ECO-RESET Study Microbiome Data Analysis (Businesswire) - P2, N=203; ECO-RESET (NCT03759041); Sponsor: Seres Therapeutics, Inc; "Seres Therapeutics, Inc...today announced preliminary microbiome data analyses from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). Following the topline clinical data...did not achieve its primary endpoints....The Company continues to conduct analyses on its SER-287 and SER-301 UC clinical stage programs to inform next steps for further development. Based on the SER-287 Phase 2b microbiome data analyses, engraftment of SER-287 bacteria was statistically significant in patients receiving SER-287 versus placebo (p ≤ 0.001 at all timepoints). The magnitude and kinetics of engraftment were comparable to Seres’ Phase 1b study. However, unlike the Phase 1b study, anticipated changes in disease-relevant metabolites post-administration with SER-287 in the Phase 2b study were not observed."

P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Seres Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Updates (Businesswire) - "SER-287 Phase 2b ECO-RESET study in ulcerative colitis:...The Company expects to obtain SER-287 Phase 2b study microbiome data in H2 2021....Seres is enrolling its Phase 1b study for SER-301, an investigational oral, rationally-designed, cultivated microbiome therapeutic...The study is being conducted in Australia and New Zealand and is designed to enroll approximately 65 subjects...Research and development expenses for the second quarter of 2021 were $36.0 million, compared with $20.1 million for the same period in 2020. The research and development expenses were primarily related to Seres’ late-stage SER-109 and SER-287 clinical development programs, as well as personnel expenses."

Commercial • Enrollment status • P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Seres Therapeutics Announces Topline Results for SER-287 Phase 2b Study in Mild-to-Moderate Ulcerative Colitis (Businesswire) - P2b, N=201; ECO-RESET (NCT03759041); Sponsor: Seres Therapeutics, Inc.; "Seres Therapeutics, Inc...announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis (UC). The study did not meet its primary endpoint of improving clinical remission rates compared to placebo. Both dosing regimens of SER-287 were generally well tolerated. Given the lack of a clinical efficacy signal identified in ECO-RESET, the Company has decided to close the open label and maintenance portions of the study...we believe this data-rich study, including microbiome analyses expected in the second half of 2021...The Company continues to advance its SER-301 program currently in a Phase 1b study...The Phase 1b is currently enrolling in Australia and New Zealand...Results from the SER-287 ECO-RESET study...will be submitted for presentation at a future scientific meeting."

Enrollment status • P2b data • Trial termination • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Seres Therapeutics to Host Virtual Investor Event on June 21, 2021 (Businesswire) - "Seres Therapeutics, Inc...announced that it will host a virtual investor event focused on SER-287 and SER-301, potential new therapeutic options for ulcerative colitis (UC) on Monday, June 21, 2021 from 8:30 a.m. to 10:00 a.m. ET...During the event, Seres’ management and Stephen Hanauer, M.D....will discuss the UC patient burden, the need for new therapeutic approaches, and SER-287 and SER-301, Seres’ microbiome therapeutic candidates in clinical development for UC....Topline clinical data from the SER-287 Phase 2b induction study are expected in mid-2021 and additional microbiome pharmacology data are expected in H2 2021."

Live event • P2b data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

[VIRTUAL] IN VIVO CHARACTERIZATION OF SER-301, AN INVESTIGATIONAL RATIONALLY-DESIGNED MICROBIOME THERAPEUTIC FOR PATIENTS WITH ACTIVE MILD-TO-MODERATE ULCERATIVE COLITIS (DDW 2021) - "SER-301 is an investigational microbiome therapeutic intended to treat UC by engrafting human-commensal bacterial strains to reduce intestinal inflammation and repair epithelial barrier damage. Preclinical assessments of SER-301 in two mouse models of colitis show that SER-301 treatment induces a noninflammatory immune profile in the colon and prevents the development of colitis. A Phase 1b study evaluating SER-301 for the treatment of active mild-to-moderate UC is currently underway (ACTRN12620000963921)."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Transplantation • Ulcerative Colitis • CD4 • IL10 • LCN2

[VIRTUAL] SER-301, AN INVESTIGATIONAL, RATIONALLY-DESIGNED BACTERIAL CONSORTIUM FOR MILD-TO-MODERATE ULCERATIVE COLITIS, RECAPITULATES THE EFFECTS OF SER-287, A CONSORTIUM OF FIRMICUTE SPORES, ON REMISSION ASSOCIATED MICROBIAL METABOLITES AND HOST GENE EXPRESSION (DDW 2021) - "SER-301, a rationally-designed consortium of bacteria, recapitulates several hypothesized mechanisms of action of SER-287. SER-301 is currently being evaluated in a Phase 1b study in adults with active mild-to-moderate UC (ACTRN12620000963921) to test the hypothesis that engraftment of drug product species results in a reduction of intestinal inflammation and repair of epithelial barrier damage."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CXCL8 • IFNG • TNFA

Seres Therapeutics Presents Data Across its Broad Microbiome Pipeline Including New 24-Week Data from SER-109 Phase 3 ECOSPOR III Study in Recurrent C. Difficile Infection at Digestive Disease Week 2021 (Businesswire) - "Preclinical data support the potential of SER-301 as a therapeutic modality for mild-to-moderate ulcerative colitis through microbiome restoration...In vivo animal model studies demonstrated that SER-301 is capable of reversing established intestinal inflammation and the development of colitis in an animal model. Further in vitro human cell-based assays confirm the bacteria in SER-301 can reduce induction of pro-inflammatory activity in intestinal epithelium cells and improve epithelial barrier integrity."

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Seres Therapeutics to Present Key Data on Investigational Microbiome Therapeutics for Recurrent C. difficile Infection and Ulcerative Colitis at the Digestive Disease Week (DDW) Annual Meeting (Businesswire) - "Seres Therapeutics, Inc...announced that it will present recent research findings from its microbiome drug development portfolio at Digestive Disease Week® (DDW), which is taking place virtually from May 21-23, 2021. With two oral presentations and two posters of distinction, Seres will demonstrate the potential of microbiome-based therapies for patients with serious diseases like recurrent Clostridioides difficile infection (CDI) and ulcerative colitis (UC)."

Clinical data • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Analysis of ALMS1 gene variants in seven patients with Alström syndrome (PubMed, Zhonghua Yi Xue Yi Chuan Xue Za Zhi) - "ALMS1 variants probably underlay the Alström syndrome in the 7 patients, and genetic testing can provide a basis for the clinical diagnosis of this syndrome. The discovery of four novel variants has expanded the mutational spectrum of Alström syndrome."

Clinical • Journal • Alstrom Syndrome

Seres Therapeutics Announces Initiation of Phase 1b Trial of SER-301 for the Treatment of Ulcerative Colitis (Businesswire) - "Seres Therapeutics, Inc...today announced that it has dosed the first patient in its Phase 1b trial evaluating SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC)....The SER-301 Phase 1b study is being conducted in Australia and New Zealand in subjects with mild-to-moderate UC and is designed to include approximately 65 patients distributed across two cohorts....Program represents Seres’ second active clinical program targeting ulcerative colitis, in addition to its ongoing SER-287 Phase 2b study."

Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

Distribution of the mutant allele of the DMRT3 gene associated with ambling gaits in Japanese native horse populations. (PubMed, Anim Sci J) - "The results revealed the presence of DMRT3:p.Ser301Ter in the Hokkaido and Yonaguni populations at allele frequencies of 0.18 and 0.02, respectively, and the observed haplotype associated with DMRT3:p.Ser301Ter was estimated as the most common haplotype in the horses in the world. Since DMRT3:p.Ser301Ter has been hypothesized to spread across Eurasian continent from Medieval England after 850 to 900 CE, our findings of the presence of DMRT3:p.Ser301Ter with the common haplotype in the Japanese native horses will provide a new insight into the history of the Japanese native horse, such as considerable level of gene flow from Eurasian continent after 850 to 900 CE."

Clinical • Journal

KCND3-Related Neurological Disorders: From Old to Emerging Clinical Phenotypes. (PubMed, Int J Mol Sci) - "Neurodevelopmental disorder with epilepsy and/or movement disorders with ataxia later in the disease course characterized the early onset forms, while a prominent ataxic syndrome with possible cognitive decline, movement disorders, and peripheral neuropathy were observed in the late onset forms. Furthermore, we described a 37-year-old patient with a de novo KCND3 variant [c.901T>C (p.Ser301Pro)], previously reported in dbSNP as rs79821338, and a clinical phenotype paradigmatic of the early onset forms with neurodevelopmental disorder, epilepsy, parkinsonism-dystonia, and ataxia in adulthood, further expanding the clinical spectrum of this condition."

Clinical • Journal • Review • Ataxia • Cardiovascular • CNS Disorders • Developmental Disorders • Dystonia • Epilepsy • Movement Disorders • Pain • Parkinson's Disease • Psychiatry

Seres Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Updates (Businesswire) - "SER-301 clinical candidate for ulcerative colitis: That study is planned to enroll subjects in Australia and New Zealand later this year. Seres is entitled to receive a $10 million milestone payment associated with the Phase 1 SER-301 clinical study initiation...SER-155 Phase 1b clinical study activities:...The Company intends to move SER-155 into a Phase 1b study later this year in collaboration with Memorial Sloan Kettering Cancer Center."

Enrollment status • Financing • New P1 trial • Graft versus Host Disease • Inflammatory Bowel Disease • Ulcerative Colitis

Computational Study of Glycerol Binding within the Active Site of Coenzyme B-Dependent Diol Dehydratase. (PubMed, J Phys Chem B) - "The MD simulations indicate that glycerol can adopt two conformations that differ with respect to the orientation of the C3-OH group; in one conformer, the C3-OH group is oriented toward Ser301 (C3-OH···Ser301), and in the other toward Asp335 (C3-OH···Asp335)...However, in AdoCbl B12-dDDH, this energy difference is higher, implying that GOL exists predominantly as C3-OH∙∙∙Asp335 conformer. These findings offer a new perspective for investigations of substrate induced inactivation of B12-dDDH enzyme."

Journal

Seres Therapeutics announces completion of enrollment in SER-109 phase 3 ECOSPOR III study for recurrent clostridium difficile infection and provides clinical pipeline updates (Businesswire) - "The SER-287 Phase 2b study is currently approximately 60% enrolled based on the 201-patient target study size. SER-287 development activity has been adversely impacted by multiple clinical sites halting non-essential procedures, including endoscopies, which may make it difficult to achieve the original enrollment target in H2 2020 as planned....Seres continues to execute on activities to advance SER-301 clinical development and the planned initiation of patient dosing in Australia and New Zealand later this year."

Trial status

Seres Therapeutics reports fourth quarter and full year 2019 financial results and corporate highlights (Businesswire) - "Seres continues to enroll the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis...Expected to enroll approximately 201 patients...the study could serve as one of two pivotal trials to enable a SER-287 Biologics License Application (BLA) submission....The Company has initiated clinical development activities for a SER-301 Phase 1 study in patients with ulcerative colitis and plans to enroll subjects in Australia and New Zealand....Research and development expenses for the fourth quarter of 2019 were $21.0 million, as compared to $24.8 million for the same period in 2018. The research and development expenses were primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109 and SER-287..."

BLA • Clinical • Enrollment status • Trial status

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301) (clinicaltrials.gov) - P3; N=380; Recruiting; Sponsor: Yuhan Corporation; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • EGFR

Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301) (clinicaltrials.gov) - P3; N=380; Not yet recruiting; Sponsor: Yuhan Corporation

New P3 trial • EGFR

Seres Therapeutics reports third quarter financial results and provides business update (Businesswire) - "SER-287 Phase 2b ECO-RESET study in ulcerative colitis...Seres expects Phase 2b ECO-RESET study top-line results in the second half of 2020...The Company has nominated the lead candidate for SER-301, a rationally-designed, live microbiome therapeutic for ulcerative colitis...Seres is entitled to a $10 million milestone payment associated with the SER-301 Phase 1 clinical study from its ongoing collaboration with Nestlé Health Science. Seres expects to initiate clinical development in early 2020."

New P1 trial • P2b data