Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

Start Date10 Jun 2026

Sponsor / Collaborator

SWOG

[+1]

NCT07037004

/ Not yet recruitingPhase 2IIT

Impact of Microbiome Modulation With CBM588 in Combination With Pembrolizumab for Adjuvant Therapy of High-Risk, Resected Renal Cell Carcinoma (RCC)

This phase II trial compares the effect of adding a Live Biotherapeutic Product called CBM588 to pembrolizumab versus pembrolizumab alone in preventing return of disease (recurrence) after surgery for patients with renal cell cancer. Pembrolizumab is an immune checkpoint inhibitor. Immunotherapy with monoclonal antibodies such as pembrolizumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for the treatment of renal cell cancer after surgery. Research has shown that changes to the composition of the healthy bacteria in the body (the microbiome), may improve a patient's response to treatment with immunotherapy. CBM588, a Live Biotherapeutic Product (LBP) containing a bacteria called Clostridium butyricum, has been shown to improve outcomes in patients treated with immunotherapy for other types of cancer. Adding CBM588 to treatment with pembrolizumab after surgery may cause changes in the microbiome that improve patient response to treatment and reduce disease recurrence, compared to pembrolizumab alone.

Start Date04 May 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT07152886

/ Not yet recruitingPhase 4IIT

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.

Start Date31 Oct 2025

Sponsor / Collaborator

The Affiliated Hospital of Qingdao University

[+8]

100 Clinical Results associated with Clostridium butyricum M588(Miyarisan Pharma)

100 Translational Medicine associated with Clostridium butyricum M588(Miyarisan Pharma)

100 Patents (Medical) associated with Clostridium butyricum M588(Miyarisan Pharma)

308

Literatures (Medical) associated with Clostridium butyricum M588(Miyarisan Pharma)

31 Dec 2026·Gut Microbes

Clostridium butyricum alleviates multiple myeloma by remodeling the bone marrow microenvironment and inhibiting PI3K/AKT pathway through the gut‒bone axis

Article

Author: Zi, Fuming ; Chen, Tingtao ; Liu, Wu ; Wei, Jing ; Kong, Leilei ; Xu, Xuan ; Liu, Chengrui ; Li, Jian ; Zhang, Zhengfeng ; Wang, Jingyu

Emerging evidence reveals a strong connection between the gut microbiota and cancer. However, the exact role of gut microbiota dysbiosis in multiple myeloma (MM) is poorly understood, and the therapeutic potential of microbiota-targeted interventions represents a promising strategy that demands urgent mechanistic and translational investigation. First, we conducted a comprehensive microbiome-metabolite analysis between MM patients and healthy individuals. The result revealed a marked compositional difference characterized by reduced abundances of butyrate-producing bacteria and diminished butyrate levels in the MM cohort. Subsequent fecal microbiota transplantation demonstrated that the gut microbiota critically modulates MM progression, with healthy donor-derived microbiota reducing the tumor burden and concomitantly elevating serum butyrate. Furthermore, through function-based culturomics screening, Clostridium butyricum (C. butyricum) was identified as a key butyrate-producing specialist. C. butyricum or its metabolite butyrate significantly reduced the systemic tumor burden in 5TGM1 mice. Notably, C. butyricum and butyrate alleviated bone marrow inflammation and osteolytic lesions by suppressing Th17 cells and IL-17 levels in the bone marrow. Moreover, cellular assays and transcriptome sequencing further revealed that butyrate could induce MM cells' apoptosis via HDAC inhibition-mediated upregulation of PPARγ, leading to sequential suppression of the PI3K/AKT pathway and antiapoptotic BCL-2 expression. This apoptotic signaling cascade was reversed by PPARγ antagonism. The direct antitumor effect was further confirmed in M-NSG mice. Our research systematically verifies the specific role of the gut microbiota in MM and provides the first evidence of the immune and molecular mechanisms by which C. butyricum alleviates MM progression, offering preclinical support for probiotic-based therapies against MM.

01 Mar 2026·POULTRY SCIENCE

Metagenomic insights into the effects of Clostridium butyricum and Bacillus subtilis probiotics on the gut microbiome and metabolic pathways of industrial broilers in Thailand

Article

Author: Cheevadhanarak, Supapon ; Kanjanavaikoon, Korntip ; Sinwat, Nuananong ; Uthaipaisanwong, Pichahpuk ; Kusonmano, Kanthida ; Sitthipunya, Athisri

Probiotic supplementation has become increasingly important in broiler production due to its safety and well-documented health benefits. The gut microbiome of broilers plays a vital role in feed digestion and maintaining intestinal homeostasis, which directly influences the efficacy of probiotics under specific farm conditions. This study aims to investigate the effects of single Bacillus subtilis probiotics and double-strain probiotics of Clostridium butyricum and B. subtilis supplementation on the gut microbiome of broilers in industrial farms. We evaluated sequencing data obtained from broilers supplemented with these probiotics through amplicon sequencing and metagenomic analysis. Our study revealed that probiotics significantly influence the cecal microbiome and its functionality in broilers. The use of double-strain probiotics increased butanoate metabolism, as well as the metabolism of glycine, serine, and threonine. This suggests their contribution from microbial gut species, including Alistipes onderdonkii, Alistipes finegoldii, Bacteroides uniformis, and Phocaeicola dorei. Supporting this finding, network analysis shows more connections between probiotics and commensal cecal microbiota, highlighting a cascade-linked association with butanoate-producing microbiota. Furthermore, single-strain B. subtilis probiotic supplementation uniquely enhanced arginine and proline metabolism, likely due to the presence of species such as Bacteroides sp. zj-18, Bacteroides cellulosilyticus, and Parabacteroides distasonis. Overall, our findings indicate that double-strain probiotics increased richness in the cecal microbial community, reshaped the microbial network, and enriched short-chain fatty acid and amino acid metabolism, contributing to improved gut health and performance in broiler production.

01 Feb 2026·ANNALS OF THORACIC SURGERY

Probiotic Prophylaxis With Clostridium butyricum for Postoperative Infections Following Lung Resection: A Propensity Score–Weighted Analysis

Article

Author: Tanaka, Toshiki ; Kurazumi, Hiroshi ; Yoshimine, Sota ; Hamano, Kimikazu ; Shimokawa, Mototsugu ; Yamamoto, Naohiro ; Murakami, Junichi

BACKGROUND:

This study investigated the efficacy and safety of perioperative Clostridium butyricum MIYARI 588 (CBM588) for preventing postoperative infections following thoracoscopic anatomic lung resection for primary lung cancer, with the hypothesis of a reduction in organ/space surgical site infection (OSS). Postoperative infections, particularly OSS, are a significant concern after lung resection. Although probiotics have shown promise in reducing infections in gastrointestinal surgery, their role in thoracic surgery is unclear.

METHODS:

This retrospective, single-center cohort study analyzed 529 patients undergoing thoracoscopic anatomic lung resection for primary lung cancer. The study compared a control group (n = 458, operated on between January 2014 and December 2021) with a probiotic group (n = 71, operated on between April 2020 and December 2021) that received perioperative CBM588 after a change in institutional practice. Inverse probability weighting (IPW) adjusted for baseline and surgical confounders.

RESULTS:

After IPW adjustment, the probiotic group demonstrated a significantly lower incidence of OSS (odds ratio, 0.08; 95% CI, 0.01-0.64; P = .017). The unadjusted incidence of all postoperative infections was 4.2% (3/71) in the probiotic group vs 9.8% (45/458) in the control group; after IPW adjustment, probiotics were associated with a significantly lower risk of all postoperative infections (odds ratio, 0.26; 95% CI, 0.07-0.95; P = .042). No significant differences were found in overall complication rates, IPW-adjusted hospital stay, 30- or 90-day mortality, reoperation, or readmission rates. An unadjusted subgroup analysis revealed a minor reduction in hospital stay for noncomplicated patients.

CONCLUSIONS:

Perioperative CBM588 may reduce OSS and all postoperative infections following thoracoscopic anatomic lung resection, suggesting a potential prophylactic benefit.

News (Medical) associated with Clostridium butyricum M588(Miyarisan Pharma)

08 Jan 2026

·www.biospace.com

Osel Enters Agreement with SWOG Cancer Research Network for First-Ever Pivotal Trial of a Microbiome-Based Therapy in Oncology

Pivotal Phase 3 trial of MO-03 builds on prior studies that demonstrated enhanced immunotherapy benefit without added toxicity MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Osel Inc., a clinical-stage biopharma company pioneering live biotherapeutic products (LBPs), today announced a clinical trial agreement with SWOG Cancer Research Network for a pivotal Phase 3 clinical trial of its lead oncology candidate, MO-03, in combination with standard immuno-oncology (IO) regimens for advanced and metastatic renal cell carcinoma (mRCC). This marks the first-ever pivotal trial of a microbiome-based oral therapy in oncology. The BIOFRONT trial will build on promising results from two prior clinical studies led by Dr. Sumanta Kumar Pal, MD, FASCO at City of Hope. In those studies, prior formulations of the product were added to nivolumab and ipilimumab or to cabozantinib and nivolumab and showed statistically significant improvements in response rates and progression free survival, without added toxicity. 1,2 A recent dose-escalation study confirmed favorable safety across higher dose levels, with no increase in immune-related adverse events, leading to a new high-potency capsule formulation, MO-03, specific for oncology. “The study represents a major advance for patients with advanced RCC,” said Dr. Pal. “While other combination approaches in the front-line setting add significant toxicity, MO-03 could possibly augment the efficacy of immunotherapy-based regimens without compromising quality of life.” The Phase 3 randomized, double-blind study will enroll approximately 700 patients across up to 150 SWOG sites in the United States, comparing MO-03 plus approved IO therapy versus placebo plus IO. The trial is supported by the National Cancer Institute (NCI), part of the National Institutes of Health. Trial initiation is slated for Q1 2026. MO-03 is a high-potency capsule formulation of Clostridium butyricum Miyairi 588 (CBM588), developed specifically for oncology by Osel and Japan’s Miyarisan Pharmaceutical Co., which will supply the GMP product. Osel holds the Investigational New Drug applications (INDs) for CBM588 and MO-03 in the United States and has exclusive marketing rights to CBM588 and MO-03 pharmaceutical products in the United States, Canada, and Europe. “We appreciate the investment that SWOG/NCI is making in this pivotal trial, which will position MO-03 as a first-in-class LBP in oncology,” said Peter P. Lee, MD, Chairman of Osel. “We are actively working with Miyarisan to engage partners who are interested in commercializing MO-03, pending positive Phase 3 results. Recent market research among US oncologists and payers shows strong interest in MO-03 and a high likelihood of coverage in the mRCC setting.” The BIOFRONT trial, formally titled “S2419, Phase III Double Blinded Trial of Immune-Based Therapy with a Live Biotherapeutic CBM588 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma,” is led by Principal Investigator (PI) Pedro C. Barata, MD, MSc, at University Hospitals Seidman Cancer Center. Co-PIs are Ulka Vaishampayan, MD, at University of Michigan Rogel Cancer Center, and Sumanta K. Pal, MD, at City of Hope. Osel holds the exclusive worldwide intellectual property rights for the use of Clostridium butyricum in oncology in combination with immune checkpoint inhibitors (ICIs) including the PD-1, PD-L1 and CTLA-4 inhibitors nivolumab, ipilimumab, pembrolizumab, cemiplimab, durvalumab, daclizumab, avelumab, or atezolizumab. The allowed claims specifically cover Clostridium butyricum as the sole live biotherapeutic product in combination regimens with ICIs and other anti-cancer agents. The intellectual property includes not only renal cell cancer but also extends to other major malignancies and microsatellite-instability high (MSI-H) cancers, including non-small cell lung cancer, melanoma, sarcoma, lymphoma, breast cancer, bladder cancer, cervical cancer, colon cancer, head and neck cancer, liver cancer, stomach cancer, or rectal cancer, supporting the broad clinical potential of MO-03. About Osel Inc. Osel Inc., a privately held biopharmaceutical company based in Mountain View, California, is focused on the development and commercialization of a portfolio of live biotherapeutic products (LBPs) to prevent or treat major medical conditions via modulation of the human microbiome. The company is a pioneer in the field of LBPs and primarily focuses on oncology and women’s health indications. Visit oselinc.com to learn more. References: 1. Ebrahimi H, Pal SK, et al. Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nat Med. 2024;30(9):2576 2585. doi: 10.1038/s41591-024-03086-4. 2. Dizman N, Pal SK, et al. Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nat Med. 2022;28(4):704 712. doi: 10.1038/s41591-022-01694-6. Contacts Media Contact Colin Sanford colin@bioscribe.com Thomas Parks, PhD tparks@oselinc.com

Phase 3Phase 1ImmunotherapyClinical Result

28 Jun 2024

·www.biospace.com

City of Hope Study Suggests Changing the Gut Microbiome Improves Health Outcomes for People Newly Diagnosed With Metastatic Kidney Cancer

City of Hope developed a novel use of biotherapeutic product CBM588 in the treatment of cancer; new research suggests the agent adjusts people’s microbiome, possibly leading to enhanced effectiveness of Food and Drug Administration-approved cancer immunotherapies Scientists are in discussions to translate City of Hope’s promising phase 1 trial results into a global phase 2/3 trial sponsored by the SWOG Cancer Research Network LOS ANGELES--(BUSINESS WIRE)-- Physician scientists from City of Hope, one of the largest cancer research and treatment organizations in the United States, found that people with metastatic kidney cancer who orally took a live biotherapeutic product called CBM588 while in treatment with immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. The phase 1 trial was published today in Nature Medicine. Microorganisms in the gut modulate the immune system. City of Hope researchers are now in discussions with the global SWOG Cancer Research Network to design a phase 2/3 trial to assess the City of Hope-identified novel use of CBM588 and microbiome modulation in people with advanced cancer. Sumanta Pal, M.D., professor and vice chair of academic affairs in City of Hope’s Department of Medical Oncology & Therapeutics Research, is slated to be co-leader of the potential phase 2/3 SWOG trial. “We at City of Hope are the first to demonstrate a live bacterial product’s ability to improve clinical outcomes for patients with kidney cancer treated with immunotherapy. CBM588 could be exciting in cancer treatment because of its potential to enhance the efficacy of immune checkpoint inhibitor-based treatment, improve patient outcomes and modulate the gut microbiota in beneficial ways,” said Pal, a City of Hope medical oncologist and corresponding author of the new study. “Ongoing and larger clinical trials are crucial to validate these benefits and address current challenges. If the positive results observed in this small trial and a previous trial with nivolumab and ipilimumab are confirmed, CBM588 could become a valuable supplement in the treatment of various cancers, particularly for patients treated with immune checkpoint inhibitors." An estimated 44% of U.S. patients with cancer in 2018 were eligible for checkpoint inhibitor drugs, according to a JAMA Network Open article that flags the increasing trend of this percentage. In the single-center, phase 1 trial, 30 people with metastatic kidney cancer were randomized to receive cabozantinib, an inhibitor of vascular endothelial growth factor receptor, and targeted immunotherapy nivolumab with or without CBM588 as first-line treatment. Participants’ gut microbiome were analyzed via stool samples in the beginning for a baseline and then 13 weeks into treatment. City of Hope has granted an exclusive worldwide license to Osel for intellectual property on the novel use of CBM588 to enhance the efficacy of checkpoint inhibitors used to treat cancer, including metastatic renal cell carcinoma. Scientists from Osel and Miyarisan Pharmaceutical Co. Ltd, the manufacturer of CBM588, collaborated on the study. To date, many studies on lung cancer, melanoma and metastatic kidney cancer, among other diseases, have shown that the composition of the gut microbiome could predict immunotherapy outcomes for patients with cancer. Current guidelines for metastatic renal cell carcinoma (kidney cancer) recommend that newly diagnosed patients receive either dual checkpoint inhibitor therapy or a combination of immunotherapy and tyrosine kinase inhibitor, but most patients eventually experience disease progression while on treatment. Positive patient outcomes usually do not last, and subsequent treatments are largely palliative rather than curative. So, physician scientists are looking to combine current strategies with new treatments that do not introduce toxic side effects, such as through microbiome modulation. In the trial, City of Hope researchers observed an increase in the abundance of unclassified Ruminococcaceae genera, which has been linked with improved clinical outcomes with immune checkpoint inhibitors in recent studies. Clostridium butyricum MIYAIRI 588, the bacterium in CBM588, produces butyric acid, which is critical for intestinal health and is a well-known immunomodulator. “While not yet part of standard cancer treatment protocols, microbiome modulation is a promising area of research with the potential to enhance the efficacy of cancer therapies, particularly immunotherapies. Current applications are primarily within clinical trials, but the growing body of evidence suggests that microbiome-based interventions may soon become a valuable component of cancer treatment strategies,” said Hedyeh Ebrahimi, M.D, M.P.H., City of Hope postdoctoral medical oncology fellow and first author of the study. City of Hope is accelerating its research on the direct link between a healthy gut and the effectiveness of immune therapies, such as CAR T cell therapy. Its enhanced microbiome program spans from basic to clinical research and includes studying the gut microbiome’s role in protecting transplant patients from complications experienced during their recovery. “This study demonstrates again that the microbiome has an important role in the efficacy and toxicity of cancer immunotherapy and can be targeted to improve outcome,” said Marcel van den Brink, M.D., Ph.D., president of City of Hope Los Angeles and City of Hope National Medical Center, and the Deana and Steve Campbell Chief Physician Executive Distinguished Chair. The Nature Medicine study entitled “Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial” was supported by Exelixis Inc. (XL184-IST123). CBM588 was supplied by Miyarisan Pharmaceutical Co., Ltd. and Osel Inc. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn. View source version on businesswire.com: Contacts Zen Logsdon 626-409-9367 zlogsdon@coh.org Source: City of Hope View this news release online at:

Phase 1ImmunotherapyLicense out/inClinical Result

22 May 2023

·www.prnewswire.com

City of Hope presents new research on cancer immunotherapies at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

Data on combination checkpoint inhibitor therapy for lymphoma, natural killer cells for leukemia and chimeric antigen receptor (CAR) T therapy for prostate cancer will be presented at June 2 to 6 meeting in Chicago LOS ANGELES, May 22, 2023 /PRNewswire/ -- City of Hope, one of the largest cancer research and treatment organizations in the United States, announced today that one of its researchers will present results from a SWOG Cancer Research Network Phase 3 study comparing nivolumab and brentuximab vedotin in patients with advanced stage classic Hodgkin lymphoma at an ASCO press briefing. Continue Reading Alex Herrera, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, will present the findings on Saturday, June 3, for Abstract LBA4 and at a plenary session on Sunday, June 4. The embargo for this abstract lifts on Sunday, June 4, at 7 a.m. CT/8 a.m. ET. City of Hope presents research on cancer immunotherapies at 2023 ASCO Annual Meeting Tweet this Other innovative City of Hope-led research on a natural killer cell engager for relapsed or difficult to treat acute myeloid leukemia, a City of Hope-developed CAR T for prostate cancer, pediatric cancer survivorship and precision medicine for breast cancer will also be presented during the conference, which attracts oncology professionals from around the world to discuss the latest clinical cancer research impacting patient care. Title: A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia Abstract Number: 7005 Session Type: Oral Session Title: Hematologic Malignancies — Leukemia, Myelodysplastic Syndromes and Allotransplant Session Date and Time: Friday, June 2, 1 to 4 p.m. CT Presentation Time: Friday, June 2 , 2:24 to 2:36 p.m. CT Presenter: Anthony Stein, M.D., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation Title : Lisocabtagene maraleucel (liso-cel) in R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of TRANSCEND CLL 004 Abstract Number: 7501 Session Type: Oral. Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT Presentation Time: Tuesday, June 6, 9:57 to 10:09 a.m. CT Presenter: Tanya Siddiqi, M.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation Title: Real-world outcomes of brexucabtagene autoleucel (brexu-cel) for relapsed or refractory (R/R) mantle cell lymphoma (MCL): A CIBMTR subgroup analysis by prior treatment Abstract Number: 7507 Session Type: Oral. Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia Session Date and Time: Tuesday, June 6, 9:45 a.m. to 12:45 p.m. CT Presentation Time: Tuesday, June 6, 11:57 a.m. to 12:09 p.m. CT Presenter: Swetha Kambhampati, M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation Title: Carvedilol for prevention of heart failure in anthracycline-exposed survivors of childhood cancer: Results from COG ALTE1621 Abstract Number: 10013 Type: Oral. Session Title: Pediatric Oncology Session Date and Time: Monday, June 5, 8 to 11 a.m. CT Presentation Time: Monday, June 5, 9:12 to 9:24 a.m. CT Presenter: Saro Armenian, D.O., M.P.H., Barron Hilton Chair in Pediatrics, professor and chair, Department of Pediatrics Title: Final results from phase I study of PSCA-targeted chimeric antigen receptor (CAR) T cells in patients with metastatic castration resistant prostate cancer (mCRPC) Abstract Number: 5019 Type: Poster Session Title: Genitourinary Cancer — Prostate, Testicular and Penile Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT Presenter: Tanya Dorff, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research Title: Healthcare utilization among individuals diagnosed with hereditary breast-ovarian cancer syndrome through a universal germline genetic testing program Abstract Number: 10604 Session Type: Poster Session Title: Prevention, Risk Reduction and Hereditary Cancer Session Date and Time: Saturday, June 3, 1:15 to 2:45 p.m. CT Presenter: Stacy W. Gray, M.D., A.M., City of Hope professor and chief, Division of Clinical Cancer Genomics, Department of Medical Oncology & Therapeutics Research Title: Efficacy and safety of atezolizumab plus cabozantinib vs cabozantinib alone after progression with prior immune checkpoint inhibitor (ICI) treatment in metastatic renal cell carcinoma (RCC): Primary PFS analysis from the phase 3, randomized, open-label CONTACT-03 study Abstract Number: LBA4500 Session Type: Oral Session Title: Genitourinary Cancer — Kidney and Bladder Session Date and Time: Monday, June 5, 11:30 a.m. to 2:30 p.m. CT Senior Author: Sumanta Kumar Pal, M.D., City of Hope professor, Department of Medical Oncology & Therapeutics Research Title: Effect of CBM588 in combination with cabozantinib plus nivolumab for patients (pts) with metastatic renal cell carcinoma (mRCC): A randomized clinical trial Abstract Number: LBA104 Session Type: Clinical Science Symposium Session Title: Role of the Microbiome in Immune Checkpoint Inhibitor Response and Resistance Session Date and Time: Sunday, June 4, 9:45 to 11:15 a.m. CT Presentation Time: 10:21 to 10:33 a.m. CT Presenter: Heydeh Ebrahimi, M.D., M.P.H., City of Hope postdoctoral fellow About City of Hope City of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center at its core, City of Hope brings a uniquely integrated model to patients spanning cancer care, research and development, academics and training, and innovation initiatives. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. City of Hope's affiliated group of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn. SOURCE City of Hope

ImmunotherapyPhase 3ASCOPhase 1Cell Therapy

100 Deals associated with Clostridium butyricum M588(Miyarisan Pharma)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A07FA	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Constipation	Japan	Miyarisan Pharmaceutical Co. Ltd.	03 Oct 1968
Diarrhea	Japan	Miyarisan Pharmaceutical Co. Ltd.	03 Oct 1968

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Clostridium difficile infection	Phase 2	-	Osel, Inc.	01 Feb 2010
Metastatic Clear Cell Renal Cell Carcinoma	Phase 1	United States	Osel, Inc.	19 Jun 2024
Metastatic Renal Cell Carcinoma	Phase 1	United States	Osel, Inc.	15 May 2024
Advanced Renal Cell Carcinoma	Phase 1	United States	Osel, Inc.	22 Jul 2022
Hematopoietic stem cell transplantation	Phase 1	United States	Osel, Inc.	22 Jul 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05122546 (ASCO_GU2025) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) with CBM588 (40mg PO QDCBM588 (40mg PO QD and 480mg IV monthly, respectively; 80mg PO BID)	vthbbkqedn(xatamhstfu) = gkcunzyvso dxffbqkwmk (hvrndliqsx ) View more	Positive	13 Feb 2025
				Cabozantinib (cabo) and nivolumab (nivo)nivolumab (nivo) without CBM588 (40mg PO QDCBM588 (40mg PO QD and 480mg IV monthly, respectively))	vthbbkqedn(xatamhstfu) = nmtfxtedwh dxffbqkwmk (hvrndliqsx ) View more
ASCO_GU2025	Not Applicable	Advanced Urothelial Carcinoma Second line	44	Pembrolizumab	bgtutoumqd(kwgrzprcks) = heeiuqnkfu vdcclbcfsx (bgmavibpcl ) View more	Positive	13 Feb 2025
				Pembrolizumab + CBM588	bgtutoumqd(kwgrzprcks) = cpkfipnsqv vdcclbcfsx (bgmavibpcl ) View more
ESMO2024	Phase 1	Metastatic Renal Cell Carcinoma	59	CBM588	goajxhztrg(fgegkhrqme) = phnnifraxo wknnkidxtj (qnhizslwlz )	Positive	15 Sep 2024
CBM588 (ASCO2024)	Phase 1	Metastatic Renal Cell Carcinoma First line	58	Nivolumab/ipilimumab	yokdsizelo(ptlhnvtkaw) = kyhrpvoarv dbpfhddjyu (knityragkz )	Positive	24 May 2024
				Nivolumab/ipilimumab + CBM588	yokdsizelo(ptlhnvtkaw) = sxcgnhhtss dbpfhddjyu (knityragkz )
NCT05122546 (ASCO_GU2024) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	cabozantinib +nivolumab	grlkabxzta(xrrhjdrmmf) = mwvykazllw qjrdceuevf (cxtmcgkxcp )	Positive	25 Jan 2024
				cabozantinib +nivolumab+CBM588	grlkabxzta(xrrhjdrmmf) = zehrazxrov qjrdceuevf (cxtmcgkxcp )
NCT05122546 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Metastatic Renal Cell Carcinoma First line	30	Nivolumab+Cabozantinib+CBM588	lnwfruobzj(aelkpzutqc): P-Value = 0.02 View more	Positive	05 Jun 2023
				Nivolumab+Cabozantinib
NCT03829111 (ASCO2023) Manual	Phase 1	Metastatic Renal Cell Carcinoma First line	29	Nivolumab + ipilimumab	dvyavaubmb(gwrntpoomd) = dqiytawgzw dpgdflbcjc (zjfldhgguf ) View more	Positive	31 May 2023
				Nivolumab + ipilimumab + CBM588	dvyavaubmb(gwrntpoomd) = vdfjbvvyhm dpgdflbcjc (zjfldhgguf ) View more
NCT03829111 (Pubmed \| Nat Med) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	Nivolumab + Ipilimumab + CBM588	ffvzkprtks(akvuwzlenz) = The primary endpoint to compare the relative abundance of Bifidobacterium spp. at baseline and at 12 weeks was not met, and no significant differences in Bifidobacterium spp. or Shannon index associated with the addition of CBM588 to nivolumab-ipilimumab were detected. fdzixjffgg (oucdmqtxie ) Not Met View more	Positive	28 Feb 2022
				Nivolumab + Ipilimumab
NCT03829111 (ASCO 12021 \| ASCO 22021) Manual	Phase 1	Metastatic Renal Cell Carcinoma	30	nivolumab+ipilimumab+CBM588	djnsglyczv(ehkkzftdvl) = Metagenomic sequencing of paired stool specimens showed an 8-fold increase in B. bifidum and a 6-fold increase in B. adolescentis in pts receiving N/I+CBM-588 from baseline to week 12. C. butyricum was detected only in pts receiving CBM-588. ftjswbmxxh (cnuylkdxld ) View more	Positive	20 May 2021
				nivolumab+ipilimumab

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Clostridium butyricum M588(Miyarisan Pharma)

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