PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY

The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.

开始日期2016-06-01

申办/合作机构

Maat Pharma SA

100 项与 MaaT-011 相关的临床结果

登录后查看更多信息

100 项与 MaaT-011 相关的转化医学

登录后查看更多信息

100 项与 MaaT-011 相关的专利（医药）

登录后查看更多信息

项与 MaaT-011 相关的新闻（医药）

2021-06-10

·BioSpace

Seres Bolsters Rationale Behind GVHD, Cancer Programs at ASCO Meeting

With an oral presentation and a poster at the American Society of Clinical Oncology (ASCO) Annual Meeting this year, Seres Therapeutics sought to bolster the case for two of its microbiome therapeutics programs, sharing data from academic collaborations in cancer immunotherapy and graft-versus-host disease (GVHD) following allogeneic hematopoietic stem cell transplantation (HSCT). Dozens of companies have launched in the past few years to develop microbiome therapies in myriad ways, seeking to deliver or target single bacterial strains or consortia, natural or engineered microbes or their metabolites or vesicles. The low-hanging fruit is treating Clostridioides difficile infection, where fecal microbial transplants have already become a standard-of-care treatment for recurrent infections, and where four companies now have therapies in or nearing Phase III testing. Seres was the first to announce positive topline Phase III efficacy data last year for its lead SER-109, an oral therapy delivering a consortium of Firmicutes spores for recurrent C. difficile infections. While no microbiome therapies have yet been approved for any indication, pharmaceutical companies have taken notice of their relative clinical success and are partnering with microbiome companies in another hot area, immune checkpoint inhibitors (ICIs). Recent clinical studies have bolstered a growing body of evidence that the gut microbiome can potentiate ICIs, which are known for their impressive anticancer response in a small subset of patients. Seres was an early player in this space as well, but recently announced it was discontinuing its SER-401 program, ending new enrollment in a Phase I combination trial with the anti-PD-1 ICI Opdivo (nivolumab) for patients with metastatic melanoma. Matthew Henn, CSO and executive vice president of R&D at Seres, said the company remains very interested in cancer and ICIs. “We have developed new research programs at Seres focused on increasing efficacy, but also ameliorating the off-target toxicities as well,” Henn said. The SER-401 trial is still generating data as well, he said, and together have allowed the company to prioritize a rationally designed cultivated therapeutics program. The poster and abstract presented at ASCO is based on a collaboration with researchers at Memorial Sloan Kettering Cancer Center, correlating response rates to four ICIs – Tecentriq (atezolizumab), Opdivo, Yervoy (ipilimumab), and Keytruda (pembrolizumab) – or combinations thereof, in 94 patients with metastatic melanoma, lung, urothelial, or renal cancer. The research, Henn said, is aimed at resolving a familiar question in the space: is there a microbiome signature that separates ICI responders from non-response across cancer patients? “What we learned, as we suspected, is basically no,” Henn said. “You need to look deeper.” But the groups did find signatures of response versus non-response within cancer types. According to Henn, further study to understand the mechanistic underpinnings of the microbiome signature differences will help elucidate opportunities for Seres as it looks to develop a clinical microbiome therapy program. The oral presentation focused on a prospective longitudinal study done with University of Cologne researchers. The partners studied 66 patients receiving HSCTs as a treatment for hematological malignancies, since standard-of-care therapies like chemotherapies and prophylactic antibiotics have been associated with reduced gut microbial diversity and GVHD. Using 16S ribosomal RNA microbiome sequencing to characterize bacteria genera, the researchers found decreased microbiome diversity across all patients, with significantly lower diversity among patients who died within a year of HSCT. Intestinal domination by Enterobacteriaceae was associated with the development of GVHD and higher mortality, and Enterococcus dominance was also associated with higher mortality risk. Enterococcus and Enterobacteriaceae are both known to cause bacterial sepsis and prominently harbor antibacterial resistance, Henn said. The findings confirmed earlier research from a Memorial Sloan Kettering Cancer Center team, and the design principles of Seres’ next clinical program, SER-155, according to Henn. Just days before ASCO, Seres announced it had received U.S. Food and Drug Administration clearance to launch a Phase Ib trial for SER-155, a rationally designed fermented bacterial consortia, in 70 immunocompromised patients following HSCT. “Our goal was to design a drug that could both decrease infection and overall abundance of vancomycin-resistant Enterococci and carbapenem-resistant Enterobacteriaceae in these patients,” Henn said. At least one other company has a microbiome-based therapy in clinical trials for GVHD: MaaT Pharma is planning a Phase III trial for MaaT011, a fecal microbial transplant composed of pooled, full-ecosystem microbiomes. Seres has two other therapies in clinical trials, both for ulcerative colitis: SER-287 is in Phase 2b testing for patients with mild-to-moderate disease, while SER-301 is in Phase Ib safety and efficacy trials. At least six other companies have microbiome therapies in clinical trials for ulcerative colitis or other forms of inflammatory bowel disease.

免疫疗法ASCO会议合作

2021-05-27

·BioSpace

Global Roundup: Abivax Eyes Phase III Following Positive UC Data

France’s Abivax SA posted positive Phase IIb data from an ulcerative colitis trial assessing ABX464, a small molecule for once-daily administration with a first-in-class mechanism of action. In the study, 254 patients with moderate to severe ulcerative colitis (UC) were treated with ABX464. Top-line data showed significant clinical efficacy in the overall patient population on primary and key secondary endpoints and a good safety profile of ABX464, the company said. After 48 weeks of maintenance treatment with ABX464, preliminary data from the first 51 patients showed further increased and durable clinical and endoscopic efficacy. Based on these results, a Phase III study is expected to begin by the end of the year. “The Phase IIb results demonstrate the potential of ABX464 to become a game changer for the treatment of ulcerative colitis patients in need of new therapeutic management options. Based on these data, we are now moving forward as quickly as possible with our phase 3 plan in ulcerative colitis as well as Phase IIb/III in Crohn’s disease to bring ABX464 to the many patients suffering from inflammatory bowel disease,” Hartmut J. Ehrlich, M.D., chief executive officer of Abivax said in a statement. Elsewhere around the globe: Elicera Therapeutics – Sweden-based Elicera raised SEK 52 million from a new share issue ahead of its planned listing on Nasdaq First North Growth Market. CanSino Biologics – China’s CanSino announced its Recombinant Novel Coronavirus Vaccine, (Adenovirus Type 5 Vector), which is under the trade name Convidecia, has been granted a Good Manufacturing Practice certificate by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI). The EU GMP certification is required to import COVID-19 vaccines into the European Union and is regarded as a recognition of leading industry standards by many authorities outside of the EU. This certification signifies CanSinoBIO’s readiness to enter more markets in Europe and globally, the company said. CanSinoBIO opened a new vaccine production site in Tianjin, China, with the expectation to produce over 200 million doses of Convidecia annually. In March, CanSinoBIO initiated a Phase I clinical trial of an inhaled version of Convidecia immediately after receiving the approval from the National Medical Products Administration of China. RDIF – The Russian Direct Investment Fund and Panacea Biotec, a leading vaccine and pharmaceutical producer in India, announced the launch of production of the Russian Sputnik V vaccine against coronavirus. The first batch produced at Panacea Biotech’s facilities at Baddi will be shipped to the Gamaleya Center in Moscow for quality control. Full-scale production of the vaccine is due to start this summer. Sputnik V was registered in India under the emergency use authorization procedure on April 12. RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V. MaaT Pharma – France’s Maat Pharma announced final results from the Phase I/II ODYSSEE clinical trial have been published in the journal, Nature Communications. The data demonstrated that the company’s initial product candidate, MaaT011, an autologous fecal microbiota transfer treatment, was safe and effective in fully restoring the gut microbiota in the 20 per-protocol analyses set of acute myeloid leukemia (AML) patients. The MaaT011 treatment showed short- and long-term signs of positive clinical outcomes including the reduction of both intestinal inflammation and gut carriage of antibiotic resistance genes, the company said. Follow-up results from the trial also showed that only 17% of the AML patients who received the MaaT011 intervention and allogeneic hematopoietic stem cell transplantation developed gastrointestinal- graft -versus-host disease. The overall survival rate in the trial was 92% at six months and 72% at two years. Vetter – Germany-based Vetter, a contract development and manufacturing organization (CDMO), has won the Axia Best Managed Companies Award for the second year in a row. The company was selected for its “clear vision, innovative approaches, sustainable management culture and sound financial management.” Adocia – France’s Adocia filed patents filed for the treatment of metabolic diseases including obesity, NASH (Non-Alcoholic Steato-Hepatitis), type 2 diabetes and neurodegenerative disorders. These patents relate to combinations of short-acting hormones administered via pump. First preclinical results obtained in obese mice population by a combination of glucagon-exenatide (BioChaperone® GluExe) show a weight loss of 25% versus 15% with exenatide alone after 14 days of treatment1. A second combination of pramlintide and exenatide (PramExe), currently in development, also presents promising properties. The pumps used are those already marketed for insulin therapy, and in particular patch-pumps, which are easy to use and suitable for this purpose. The user can adjust the maximal tolerable dose and therefore optimize the benefit/risk balance, the company said. Medtronic plc – Ireland-based Medtronic announced it secured a CE Mark for expanded functionality of the company's InPen smart2 insulin pen for multiple daily injections (MDI). The company also announced CE Mark for its Guardian 4 sensor3, which requires no fingersticks1 for calibration or diabetes treatment decisions. The CE Mark allows this next-generation sensor to be integrated with either the MiniMed 780G insulin pump system or InPen, or for stand-alone continuous glucose monitoring (CGM) use.

First in Class疫苗小分子药物紧急使用授权

100 项与 MaaT-011 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床2期	法国	Maat Pharma SA	2016-06-01
微生态失调	临床2期	法国	Maat Pharma SA	2016-06-01
胃肠道疾病	临床2期	-	Maat Pharma SA	-