相关临床试验
21
8 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
8
38.1%
已完成
4
19.1%
招募中
5
23.8%
终止
4
19.1%
暂无批准数据
- The global microbiome oncology market is forecast to grow from USD 353.20 million in 2026 to USD 1.94 billion by 2031, representing a compound annual growth rate of 40.7%. - Scientific evidence increasingly links gut microbiota composition to immune regulation, inflammation, and patient response to immune checkpoint inhibitors targeting PD-1, PD-L1, and CTLA-4. - Melanoma and colorectal cancer dominate research focus, with next-generation sequencing leading as the primary technology and immunotherapy enhancement as the key application. - Key players include Seres Therapeutics, Vedanta Biosciences, MaaT Pharma, Enterome, and 4D Pharma, with multiple pipeline candidates in Phase I through Phase III clinical trials.
- The global microbiome therapeutics market reached USD 288.8 million in 2025 and is projected to hit USD 4,023.1 million by 2034, growing at a CAGR of 34.90%. - Seres Therapeutics achieved the first positive pivotal clinical results for a targeted microbiome drug candidate, SER-109, which received FDA Breakthrough Therapy and Orphan Drug Designations for recurrent C. difficile infection. - Enterome raised USD 19 million in Series E funding in June 2025 to advance OncoMimic-based cancer immunotherapies and inflammatory bowel disease therapies into phase I trials. - The field is shifting from traditional fecal microbiota transplants toward defined bacterial consortia and engineered "designer bacteria" that function as living drug factories inside the body.
- Enterome's OncoMimics™ immunotherapy EO2463 achieved a 100% objective response rate (6/6 patients) when combined with rituximab in previously untreated follicular lymphoma patients, with 5 complete responses and 1 partial response. - The SIDNEY Phase 2 trial also demonstrated a 52.6% objective response rate with EO2463 monotherapy in follicular lymphoma patients in the watch-and-wait setting, offering an alternative to standard watchful waiting. - EO2463 represents a novel off-the-shelf immunotherapy that targets multiple B-cell markers (CD20, CD22, CD37, CD268) through bacteria-derived peptides that mimic tumor antigens and expand memory T-cells. - Enterome plans to initiate Phase 3 testing of EO2463 in watch-and-wait patients in 2026, addressing an unmet medical need in follicular lymphoma treatment.
- The FDA has granted Fast Track designation to Enterome's EO2463, a first-in-class OncoMimics immunotherapy for follicular lymphoma patients in the low tumor burden "watch-and-wait" setting. - EO2463 demonstrated marked efficacy as a monotherapy with excellent safety and tolerability in interim data from the ongoing Phase 2 SIDNEY trial. - The innovative therapy combines four synthetic peptides that mimic B cell markers CD20, CD22, CD37, and CD268, designed using AI and machine learning from 23 million bacterial genes. - Enterome plans to initiate a registrational Phase 3 trial in 2026, targeting an unmet medical need for patients who currently receive no treatment despite having progressive cancer.
- The FDA has granted Fast Track designation to Enterome's EO2463 for the treatment of follicular lymphoma, a significant regulatory milestone for the company. - This designation supports the planned launch of a phase 3 clinical trial in watch-and-wait patients scheduled for 2026. - Fast Track status is designed to facilitate the development and expedite the review of drugs addressing unmet medical needs in serious conditions.
- Research demonstrates that gut microbiota significantly influences cancer treatment outcomes, with disrupted gut bacteria associated with resistance to immunotherapies and chemotherapy. - Clinical trials show promising results for microbiome-targeted interventions, including fecal microbiota transplantation achieving 66.7% progression-free survival in renal cell carcinoma patients and 80% overall response rate in lung cancer. - Multiple biotechnology companies are developing novel treatments that leverage gut bacteria, including Enterome's OncoMimics peptides and MaaT Pharma's microbiome ecosystem therapy, both advancing through Phase 2 and 3 trials. - Antibiotic use poses significant risks to cancer patients by reducing microbiome diversity and impairing immune responses, with studies showing increased death risk and reduced immunotherapy effectiveness.
