{"id":4374,"date":"2019-06-04T07:55:22","date_gmt":"2019-06-04T07:55:22","guid":{"rendered":"https:\/\/maat.swebwp.oci.eu\/?p=4374"},"modified":"2023-09-25T14:01:18","modified_gmt":"2023-09-25T14:01:18","slug":"maat-pharma-completes-third-positive-dsmb-assessment-setting-high-safety-standard-for-human-intestinal-microbiome-whole-ecosystem-based-therapeutics","status":"publish","type":"post","link":"https:\/\/maat.swebwp.oci.eu\/fr\/maat-pharma-completes-third-positive-dsmb-assessment-setting-high-safety-standard-for-human-intestinal-microbiome-whole-ecosystem-based-therapeutics\/","title":{"rendered":"MaaT Pharma Completes Third Positive DSMB Assessment Setting High Safety Standard for Human Intestinal Microbiome Whole Ecosystem-Based Therapeutics"},"content":{"rendered":"[vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3″ shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/6″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb2\/3″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]Independent Data Safety Monitoring Board (DSMB) confirms continuation of Phase II HERACLES study in acute GvHD with no safety concerns occurring within the study<\/b>[\/vc_column_text][vc_column_text]Lyon, France, June 24, 2019<\/strong> \u2013 MaaT Pharma announced today the third positive assessment of the company\u2019s lead biotherapeutic, MaaT013, in the ongoing Phase II HERACLES study (NCT03359980)<\/a> by an independent Data and Safety Monitoring Board (DSMB). Following the second review<\/a> in April with 10 patients, this review confirms the absence of safety issues during the trial after 15 patients treated. MaaT Pharma has developed a rigorous quality control process for the production of its integrated Microbiome Restoration Biotherapeutic (MMRB) platform, which has been accepted by five European agencies and reviewed by the US Food and Drug Administration (FDA). The process ensures that the highest quality of donor-derived intestinal microbiota are present in the Company\u2019s biotherapeutics. The Company is investigating the use of MaaT013 in steroid-resistant, gastrointestinal-predominant, acute Graft-versus- Host-Disease (SR GI aGvHD) after allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT).[\/vc_column_text][nectar_single_testimonial testimonial_style=\u00a0\u00bbsmall_modern\u00a0\u00bb image=\u00a0\u00bb1711″ color=\u00a0\u00bbDefault\u00a0\u00bb quote=\u00a0\u00bb\u201cRe-establishing the whole microbial ecosystem in the gut to treat serious diseases is a promising approach with the potential to become a widely-used therapeutic modality in the near future. Although the field is in an early stage, MaaT Pharma is pioneering efforts to set the highest standards of safety for developing human intestinal microbiome-based therapeutics and is establishing a standardized drug development framework for these products in close association with European regulatory agencies,\u201d<\/p>\n

\u201cOur lead product, MaaT013, the first reproducible, full-ecosystem, off-the-shelf, enema formulation, remains on track to show the potential beneficial effects in hemato-oncological patients with GI-predominant GvHD and we look forward to communicating top- line data from the Phase II HERACLES trial later this year.\u201d\u00a0\u00bb name=\u00a0\u00bbsaid Herv\u00e9 Affagard \u00a0\u00bb subtitle=\u00a0\u00bbCo-founder and CEO of MaaT Pharma\u00a0\u00bb][vc_column_text]MaaT Pharma is a funding member, together with three other European microbiome companies, that have established a joint collaborative \u2018Intestinal Microbiome-based Medicines European Task Group\u2019 under the umbrella of the Pharmabiotic Research Institute (PRI) to create a proposal with recommendations for a common European regulatory framework for commercializing treatments based on targeting a patient\u2019s microbiome. The consortium was formed in May 2019 to engage with key stakeholders, including regulatory authorities, with the aim of obtaining a universally accepted product classification for human intestinal microbiome whole ecosystem-based therapeutics across the European Union. Over the last 10 years, the microbiome developed into a promising new therapeutic opportunity for the treatment of a range of serious diseases and several high-impact scientific studies have demonstrated that restoring a healthy microbiome can significantly benefit patients. Moving towards clinical proof-of-concept, it is important to abide by very strict clinical protocols and define a rigorous regulatory process for this drug entity as a new drug class. To find out more about the consortium and its goals, click here<\/a>.[\/vc_column_text][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/6″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][\/vc_row][vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3″ shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/1″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017″ style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n

About HERACLES<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]The HERACLES<\/strong> study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of MaaT Pharma\u2019s lead microbiome restoration drug candidate, MaaT013, in steroid- resistant gut predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction induced by the donor cells derived from the hematopoietic stem cell graft against the host and have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics, and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition.[\/vc_column_text][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017″ style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n

About MaaT013<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT013<\/strong> is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharma\u2019s integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the company\u2019s centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.[\/vc_column_text][nectar_highlighted_text highlight_color=\u00a0\u00bb#e9a017″ style=\u00a0\u00bbhalf_text\u00a0\u00bb]\n

About MaaT Pharma<\/em><\/h3>\n[\/nectar_highlighted_text][vc_column_text]MaaT Pharma<\/strong>, a clinical stage company, has established the most complete approach to restoring patient- microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.[\/vc_column_text][\/vc_column][\/vc_row][vc_row type=\u00a0\u00bbin_container\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb top_padding=\u00a0\u00bb3%\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3″ shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb shape_type=\u00a0\u00bb\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/4″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][vc_column centered_text=\u00a0\u00bbtrue\u00a0\u00bb column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/2″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][nectar_btn size=\u00a0\u00bbmedium\u00a0\u00bb open_new_tab=\u00a0\u00bbtrue\u00a0\u00bb button_style=\u00a0\u00bbsee-through-2″ color_override=\u00a0\u00bb#5bc0cc\u00a0\u00bb hover_color_override=\u00a0\u00bb#5bc0cc\u00a0\u00bb hover_text_color_override=\u00a0\u00bb#ffffff\u00a0\u00bb icon_family=\u00a0\u00bbnone\u00a0\u00bb url=\u00a0\u00bbhttps:\/\/maat.swebwp.oci.eu\/\/wp-content\/uploads\/2019\/07\/MaaT-Pharma-Completes-Third-Positive-DSMB-Assessment-Setting-High-Safety-Standard-for-Human-Intestinal-Microbiome-Whole.pdf\u00a0\u00bb text=\u00a0\u00bbDownload our Press Release (PDF)\u00a0\u00bb][\/vc_column][vc_column column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/4″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][\/vc_column][\/vc_row][vc_row type=\u00a0\u00bbfull_width_background\u00a0\u00bb full_screen_row_position=\u00a0\u00bbmiddle\u00a0\u00bb bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb scene_position=\u00a0\u00bbcenter\u00a0\u00bb text_color=\u00a0\u00bbdark\u00a0\u00bb text_align=\u00a0\u00bbleft\u00a0\u00bb top_padding=\u00a0\u00bb5%\u00a0\u00bb bottom_padding=\u00a0\u00bb5%\u00a0\u00bb overlay_strength=\u00a0\u00bb0.3″ shape_divider_position=\u00a0\u00bbbottom\u00a0\u00bb][vc_column column_padding=\u00a0\u00bbpadding-2-percent\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/2″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][split_line_heading]\n

Stagiaire en Affaires r\u00e9glementaires\/ Assurance Qualit\u00e9<\/h2>\n[\/split_line_heading][vc_row_inner column_margin=\u00a0\u00bbdefault\u00a0\u00bb top_padding=\u00a0\u00bb15″ bottom_padding=\u00a0\u00bb25″ text_align=\u00a0\u00bbleft\u00a0\u00bb][vc_column_inner enable_animation=\u00a0\u00bbtrue\u00a0\u00bb animation=\u00a0\u00bbfade-in-from-bottom\u00a0\u00bb column_padding=\u00a0\u00bbno-extra-padding\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb column_link_target=\u00a0\u00bb_self\u00a0\u00bb width=\u00a0\u00bb1\/1″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text]MaaT Pharma<\/strong> est une jeune entreprise de biotechnologie lyonnaise qui \u00e9volue sur le secteur de la sant\u00e9. L\u2019entreprise a \u00e9t\u00e9 cr\u00e9\u00e9e fin 2014<\/p>\n

MaaT Pharma has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved a proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions.\u00a0Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column column_padding=\u00a0\u00bbpadding-2-percent\u00a0\u00bb column_padding_position=\u00a0\u00bball\u00a0\u00bb background_color_opacity=\u00a0\u00bb1″ background_hover_color_opacity=\u00a0\u00bb1″ column_link_target=\u00a0\u00bb_self\u00a0\u00bb column_shadow=\u00a0\u00bbnone\u00a0\u00bb column_border_radius=\u00a0\u00bbnone\u00a0\u00bb width=\u00a0\u00bb1\/2″ tablet_width_inherit=\u00a0\u00bbdefault\u00a0\u00bb tablet_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb phone_text_alignment=\u00a0\u00bbdefault\u00a0\u00bb column_border_width=\u00a0\u00bbnone\u00a0\u00bb column_border_style=\u00a0\u00bbsolid\u00a0\u00bb][vc_column_text css=\u00a0\u00bb.vc_custom_1538129316169{margin-bottom: 18px !important;}\u00a0\u00bb]\n

Missions<\/h5>\n[\/vc_column_text][vc_column_text css=\u00a0\u00bb.vc_custom_1538141988698{margin-bottom: 18px !important;}\u00a0\u00bb]Dans le cadre de la mise en place et du suivi des \u00e9tudes cliniques de phase I et II, vous aurez en charge de v\u00e9rifier la conformit\u00e9 du laboratoire \u00e0 la r\u00e9glementation clinique (ICHE6) et d\u2019adapter le syst\u00e8me qualit\u00e9 (harmonisation, nouvelles proc\u00e9dures, documents source pour la mise en place et le suivi des \u00e9tudes\u2026) en cons\u00e9quence. A l\u2019interface qualit\u00e9\/r\u00e9glementaire et clinique et en lien avec la CRO, vous acquerrez une maitrise de la r\u00e9glementation clinique et de sa mise en application et son suivi en routine tout en d\u00e9veloppant vos capacit\u00e9s r\u00e9dactionnelles et relationnelles.
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Profil recherch\u00e9<\/h5>\n[\/vc_column_text]
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