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Enterome S.A.. (3/24/21). "Press Release: Enterome Receives FDA IND Clearance for EO2463, an ‘OncoMimic’ based Immunotherapy Targeting Liquid Tumors".
Region | United States (USA) | |
Organisation | Enterome S.A. | |
Organisation 2 | FDA (US Food and Drug Administration) | |
Group | United States (govt) | |
Product | EO2463 (Enterome) | |
Product 2 | phase 2 study | |
Person | Fagerberg, Jan (Enterome 202103 CMO formerly Micromet 200911 SVP + CMO) | |
Person 2 | Perrier, Marine (Enterome 202103 Head of External Communications + IR before Citigate Dewe Rogerson) | |
Phase1/2 clinical trials in patients with follicular lymphoma and marginal zone lymphoma expected to begin in Q2 2021
ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, today announces that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1/2 clinical trial of EO2463, a potential treatment for indolent non-Hodgkin B-cell lymphomas (iNHL). EO2463 will be Enterome’s second OncoMimics candidate to enter the clinic.
EO2463 is an innovative, off-the-shelf immuno-oncology candidate that combines four OncoMimics of B lymphocytes-specific lineage markers. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes enriched in iNHL.
OncoMimics are peptides, derived from bacteria present in the gut microbiome, that closely mimic either overexpressed tumor-associated antigen (TAA) or lineage-specific markers in solid and liquid tumors, respectively. OncoMimics are selected based on their ability to trigger the rapid activation of memory T-cells that were previously exposed to gut bacteria antigens similar to TAAs, and to direct a targeted cell-killing immune response against the tumor.
The primary objective of the study is to demonstrate safety, tolerability and efficacy of EO2463 as a monotherapy and in combination with standard of care (rituximab and rituximab in combination with lenalidomide) in 60 patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL).
“With EO2463, we are expanding the potential utility of our OncoMimics pipeline into the field of liquid tumors. This milestone highlights the rapid progress that we are making with this potentially transformative cancer immunotherapy approach and builds on the ongoing trials of EO2401 in glioblastoma and in adrenal tumors. We are extremely excited by our OncoMimics approach as we believe it can be used to target any tumor antigen, and thus has therapeutic potential across all cancers. We look forward to updating you on the progress of this clinical trial, which is expected to start in the second quarter of 2021,” said Jan Fagerberg, Chief Medical Officer of Enterome.
Contacts
Enterome
Marine Perrier
Head of External Communications and Investor Relations
investorrelations@enterome.com
Media Relations
Mark Swallow / Sylvie Berrebi / David Dible
Citigate Dewe Rogerson
Tel. +44 207 638 9571
enterome@citigatedewerogerson.com
About Enterome
Enterome is a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health. Enterome’s success is based on its unique ability to identify small proteins and peptides (“effectors”) from gut bacteria that can deliver a therapeutic benefit in humans.
Enterome is leveraging this unique ability to develop two highly promising pipelines of clinical and pre-clinical candidates with a focus on cancer, inflammatory and metabolic diseases:
> OncoMimics: highly effective, off-the-shelf immunotherapies against cancers (EO2401, EO2463). EO2401 is in Phase 1/2 clinical trials in patients with glioblastoma and adrenal tumors. EO2463, is about to enter clinical development for indolent non-Hodgkin B-cell lymphomas.
> EndoMimics: a new generation of biologics targeting inflammatory diseases (EM101) and metabolic diseases such as Type 2 diabetes.
These pipelines have been created using Enterome’s highly efficient proprietary drug discovery platform that uses machine learning and lab assays to interrogate and decode the world’s largest database of gut bacterial proteins, a unique source of novel precision drugs.
In addition, Enterome’s clinical candidate Sibofimloc (also referred to as TAK-018) is advancing through Phase 2 clinical trials in Crohn’s disease. Sibofimloc has been partnered with Takeda globally, with Enterome retaining a significant profit share in the US.
Enterome is headquartered in Paris (France) and is backed by leading venture capital investors.
Record changed: 2023-06-05 |
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More documents for Enterome S.A.
- [1] Enterome S.A.. (7/18/22). "Press Release: Enterome Signs Major Strategic R&D Collaboration with Nestlé Health Science to Develop and Commercialize New AllerMimics and EndoMimics Immunotherapies for Food Allergies and Inflammatory Bowel Disease". Paris....
- [2] Enterome S.A.. (9/23/20). "Press Release: Enterome Announces First Patient Dosed in Phase 2a Trial of Sibofimloc in Crohn’s Disease". Paris & Cambridge, MA....
- [3] Enterome S.A.. (6/25/20). "Press Release: Enterome Completes €46.3 Million ($52.6 Million) Financing to Progress the Clinical Development of Its Therapeutic Pipeline". Paris & Cambridge, MA....
- [4] Enterome S.A.. (11/7/19). "Press Release: Enterome Enters Research Collaboration with Major Cancer Center Focused on New Microbiome-derived Immunotherapies". Paris & Cambridge, MA....
- [5] Enterome S.A.. (10/23/18). "Press Release: Enterome Signs Global Licensing, Co-development and Co-Promotion Agreement with Takeda for the Treatment of Crohn’s Disease". Paris & Cambridge, MA....
- [6] Enterome S.A.. (1/4/18). "Press Release: Enterome Raises €32 Million ($38.5 Million) in a Series D Financing". Paris & Cambridge, MA....
- [7] Enterome S.A.. (7/12/17). "Press Release: Enterome Appoints Mary Thistle to Its Board of Directors". Paris....
- [8] Enterome S.A.. (7/11/17). "Press Release: Enterome and Nestlé Health Sciences Launch New Diagnostics Company". Paris....
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