ENTEROME IS HARNESSING THE MICROBIOME-IMMUNO-INFLAMMATION AXIS TO CREATE NEXT-GENERATION THERAPEUTICS
Enterome is pioneering the discovery and development of novel pharmaceuticals based on its unrivalled understanding of the interaction between the gut microbiome and the immune system – the Microbiome-Immunoinflammation Axis.
Enterome is using this expertise to generate a pipeline of clinical and pre-clinical candidates (small molecules and peptides) with a focus on cancer, autoimmune, inflammatory and metabolic diseases.
Enterome’s strategy is to develop new pharmaceuticals that deliver significantly improved treatments that benefit patients globally and also generate value for its shareholders.
Immuno-oncology is today a cornerstone of cancer therapy that aims to:
- activate the immune system to enhance and/or create anti-cancer immune responses, and to
- overcome the immuno-suppressive mechanisms that cancer cells have developed against the immune system.
Enterome’s cancer immunotherapy solution is based on its unique OncoMimics approach. The Enterome approach permits to overcome a frequent challenge of current Immuno-Oncology therapy of insufficient immune cells activation and expansion.
Enterome’s approach permits to activate specific CD8+ T-cells reactive against self-antigens that leads to a sustained immune response against cancer cells.
OncoMimics are microbiome-derived antigens – short peptides – that have a very high amino acid sequence homology with known and well characterized human tumor antigens.
The Company’s lead immuno-oncology clinical candidate from this platform, EO2401, is an innovative off-the-shelf immunotherapy, which entered Phase 1b/2a clinical trials in Glioblastoma and Adrenal Tumors during in July and September 2020 respectively.
The Company’s second OncoMimic candidate EO2463 is being prepared as a clinical candidate for B-cell malignancies.
INFLAMMATORY AND METABOLIC DISEASES
Inflammatory and metabolic diseases include many disorders and conditions such as inflammatory bowel diseases, type 2 diabetes or obesity.
Enterome’s solution is based on its unique EndoMimics approach, which can generate the next generation of precision biologics by using the natural reservoir of thousands of safe and tolerized human-like effector proteins/ hormones that are produced by the gut bacteria.
The first EndoMimics candidate to emerge from the platform, EM101, is a human hormone mimetic produced by commensal bacteria. EM101 is currently in pre-clinical development for inflammatory bowel disease (IBD).
In November 2016, Enterome entered an Immuno-Oncology collaboration with BMS. The collaboration is focused on the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be developed as potential companion diagnostics and therapeutics for cancer.
Additionally, the collaboration is seeking to identify novel microbiome-derived biomarkers in an effort to improve clinical outcomes for patients treated with BMS’s Immuno-Oncology portfolio.
The collaboration combines BMS’s expertise in the discovery and development of novel immunotherapies with Enterome’s leadership in understanding the microbiome-human health axis and proprietary technologies to support the discovery of novel immunotherapy agents and biomarkers.
In October 2018, Enterome signed a global licensing, co-development and co-promotion agreement with Takeda. The agreement covers Enterome’s investigational drug candidate EB8018 (now called sibofimloc) in patients with Crohn’s disease, with the potential to expand to other gastrointestinal (GI) disorders and liver diseases. This first- in-class small molecule drug candidate acts by blocking the FimH virulence factor and is advancing through Phase 2 clinical trials in Crohn’s disease driven by Takeda. Enterome retains a significant profit share in the US.
Prior to this, in January 2016, Enterome entered a strategic drug discovery collaboration with Takeda to research and develop potential new therapeutics directed at microbiome targets thought to play a crucial role in GI disorders, including inflammatory bowel diseases (e.g. ulcerative colitis) and motility disorders (e.g. irritable bowel syndrome).
Pierre Belichard has served as Enterome’s Chief Executive Officer and as a member of the company’s Board of Directors since 2011.
Dr. Belichard is a serial entrepreneur with more than 25 years’ experience in the biopharmaceutical industry. Prior to founding Enterome, He served as Vice President of Mergers and Acquisitions and Business Development at Sanofi Ophthalmology from 2009 to 2011. Dr. Belichard was the Founder of Fovea Pharmaceuticals SA., which was acquired by Sanofi in 2009, and served as its Chief Operating Officer from 2005 to 2009. From 2002 to 2004, Dr. Belichard served as Vice President of Business Development at UroGene, S.A., a company acquired by Pierre Fabre in 2004. From 2000 to 2002, he served as head of European commercial operations at Ethypharm S.A.
Dr. Belichard holds a Pharm.D. from Grenoble Faculty of Medicine and Pharmacy, Ph.D. from University Pierre and Marie Curie and an M.B.A. from INSEAD.
CHIEF EXECUTIVE OFFICER
Christelle Dumoussaud has served as Enterome’s Chief Financial Officer since 2015.
Ms. Dumoussaud has more than 20 years’ experience in financial departments of various industries. In 2015, she served as General Secretary at Laboratoire Hepatoum-Dermophil Indien and in 2014 she served as a financial consultant at Expert & Consult. From 2012 to 2013, Ms. Dumoussaud served as Administration and Finance Manager at Almavia and as General Secretary at Polygon/Munters France-Belgium from 2007 to 2012.
Ms. Dumoussaud worked at Fournier/Solvay Pharma from 1997 to 2007, serving as the Finance Director from 2005 to 2007. She served as the Chief Financial Officer of Fournier Pharma Belgium from 2001 to 2004. Ms. Dumoussaud holds a Master in Business Management from the ISC Paris.
CHIEF FINANCIAL OFFICER
Marie-Laure Bouttier has been Enterome’s Chief Operating Officer from 2011 to 2018 and Chief Corporate Officer since 2018.
Previously, Ms. Bouttier served as the Business Development & Contract Manager at Sanofi S.A. from 2009 to 2011. Ms. Bouttier joined Sanofi, as a result of its acquisition of Fovea Pharmaceuticals SA in 2009. Ms. Bouttier joined Fovea at its inception in 2005 as a business development associate and held a position in the licensing and contractual operations through the sale to Sanofi. From 2003 to 2005, Ms. Bouttier was a business development associate at UroGene, S.A. She holds a Masters in Economics from Université Lyon 2.
CHIEF CORPORATE OFFICER
Jan Fagerberg has served as Enterome’s Chief Medical Officer since January 2019.
From 2017 to December 2018, Dr. Fagerberg served as Senior Adviser at Fagerberg Oncology SA.
Dr. Fagerberg served as Chief Medical Officer at SOTIO a.s. from 2013-2017. From 2012 to 2013, he served as Vice President, Global Development and Managing Director at Amgen Research GmbH.
Prior to this, Dr. Fagerberg served as the Senior Vice President and Chief Medical Officer at Micromet A/G from 2009 to 2012, prior to its acquisition by Amgen.
Dr. Fagerberg was the Medical Director at TopoTarget from 2006 to 2009. Dr. Fagerberg held various positions of increasing responsibility at Roche from 1999 to 2006 in medical and clinical operations after ten years of oncology practice and academic translational immune-oncology research at Karolinska Hospital. Dr. Fagerberg holds an M.D. and Ph.D. from the Karolinska Institute.
CHIEF MEDICAL OFFICER
Catherine has more than 25 years’ experience working in clinical research and regulatory affairs with pharma and biotech companies, especially in the areas of immunology and oncology. She developed robust expertise for developing innovative healthcare products from Phase 1 to Phase 3 studies with an excellent product knowledge concerning US and EU regulations. She conducted many projects in development with interactions with the US FDA and the European health authorities (EMA and national competent authorities) including also interactions with European payers (HTA bodies).
Prior to joining Enterome in March 2019, Ms. Mathis served as Chief Operating Officer at ElsaLys biotech dedicated to the development of mAbs in onco-hematology.
Previously she was VP, Regulatory Affairs at TxCell, a cell therapy company. Ms. Mathis also served for several years as Head of Regulatory Affairs at Transgene developing immunotherapy products based on recombinant viruses.
Ms. Mathis started her career at Ipsen and Sanofi Pasteur in clinical research. She has a Pharm.D. and holds a Master’s degree in toxicology.
CHIEF DEVELOPMENT OFFICER
Christophe Bonny has been Enterome’s Chief Scientific Officer since 2016.
Dr. Bonny has approximately 20 years’ experience in the field of molecular biology and signaling pathways and 15 years in the field of hit identification to candidate selection. Before joining Enterome, Dr. Bonny served as the Chief Scientific Officer at Bicycle Therapeutics from 2013 to 2016.
From 2006 to 2012, Dr. Bonny served as the Chief Scientific Officer of Xigen SA and also served as its President from 2011 to 2012. Dr. Bonny received the Pfizer Research Prize in 2005. He holds a Ph.D. in biochemistry and molecular biology from Neuchâtel University.
CHIEF SCIENTIFC OFFICER
Catherine Marle has more than two decades of experience in the pharmaceutical sector with leadership roles in clinical development and alliance management. Prior to joining Enterome as Chief Operating Officer, Catherine held senior international management positions across multiple early- and late-stage clinical programs at . large pharmaceutical companies and CROs, such as Sanofi, Pfizer and IQVIA. In these positions, she had oversight for all aspects of the clinical development, including interactions with regulatory authorities and bringing the product to market. Her experience covers several major therapeutic areas such as oncology, cardiovascular, CNS, neurology, rare diseases. Catherine holds a post graduate diploma in molecular biology from Pierre et Marie Curie University. Catherine studied in France and the US including at Stanford University.
CHIEF OPERATING OFFICER
BOARD OF DIRECTORS
Georges Gemayel has served as chairman of Enterome’s board of directors since 2015.
Dr. Gemayel’s has over 25 years of experience in the biopharmaceutical industry, including management and executive positions.
From June 2008 to November 2009, Dr. Gemayel served as President and Chief Executive Officer of Altus Pharmaceuticals, Inc. From 2003 to 2008, Dr. Gemayel was Executive Vice President at Genzyme Corporation where he was responsible for the company’s global therapeutics, transplant, renal and biosurgery businesses. From 1998 to 2003, Dr. Gemayel held progressively senior roles at Hoffmann La-Roche Inc. and Roche Laboratories, Inc., most recently as Vice President, National Specialty Care, responsible for its U.S. business for dermatology, oncology, transplantation, hepatitis and HIV.
Dr. Gemayel currently serves on the boards of directors of U.S. publicly-traded companies, Supernus Pharmaceuticals, Inc. and Momenta Pharmaceuticals, the board of directors of Orphazyme A/S, which is publicly traded on Nasdaq Copenhagen and the boards of directors of OxThera AB and Dynacure. Dr. Gemayel received his Pharm.D. from St. Joseph University and his Ph.D. in Pharmacology from Paris-Sud University.
CHAIRMAN OF THE BOARD
Pierre Belichard has served as Enterome’s Chief Executive Officer and as a member of the company’s Board of Directors since 2011.
Dr Belichard is a serial entrepreneur with more than 20 years’ experience in the biopharmaceutical industry. Prior to founding Enterome, He served as Vice President of Mergers and Acquisitions and Business Development at Sanofi Ophthalmology from 2009 to 2011. Dr. Belichard was the Founder of Fovea Pharmaceuticals SA., which was acquired by Sanofi in 2009, and served as its Chief Operating Officer from 2005 to 2009. From 2002 to 2004, Dr. Belichard served as Vice President of Business Development at UroGene, S.A., a company acquired by Pierre Fabre in 2004.
From 2000 to 2002, he served as head of European commercial operations at Ethypharm S.A. Dr. Belichard holds a Pharm.D. from Grenoble Faculty of Medicine and Pharmacy, Ph.D. from University Pierre and Marie Curie and an M.B.A. from INSEAD.
CHIEF EXECUTIVE OFFICER
Pierre Cassigneul has served as a member of our board of directors since 2013.
Mr. Cassigneul has served as the President and Chief Executive Officer at NMS Labs, Inc. since 2013. Before that, from January 2013 to May 2013, Mr. Cassigneul was Chief Executive Officer at Predictive Biosciences and, from 2003 to 2012, President and Chief Executive Officer at XDX Inc. Mr. Cassigneul served as the Vice President, Diabetes Management at Becton Dickinson & Company from 2001 to 2002, Senior Vice President, Business Operations at Bayer U.S. from 1997 to 2001 and Business Unit Vice President & General Manager at Johnson & Johnson from 1991 to 2001.
Mr. Cassigneul currently serves on the board of directors of NMS Labs, Inc. Mr. Cassigneul holds an M.B.A. equivalent from Ecole Supérieure de Commerce de Reims.
DIRECTOR / INDEPENDENT
Isabelle de Cremoux has served as a member of our board of directors since 2008.
Since 2001, Ms. de Cremoux has served as Chief Executive Officer and Managing Partner of Seventure Partners, where she established and leads the life sciences team. Previously, she worked at Arthur Andersen LLP from 1991 to 1993. From 1998 to 2001, Ms. de Cremoux served as Deputy Director of Business Development at Laboratoire Fournier S.A.S. / Abbott Laboratories. From 1993 to 1998, Ms. de Cremoux worked at Pfizer France and Pfizer Europe, where she held various positions within management, clinical research and business development. Ms. de Cremoux holds a degree in Engineering from l’Ecole Centrale Paris.
DIRECTOR / SEVENTURE PARTNERS
Dr. Roger Garceau has served as a member of our board of directors since 2016.
Dr. Garceau is a board-certified pediatrician with approximately 30 years of experience in pharmaceutical development, global regulatory and medical affairs. From 2008 to 2016, Dr. Garceau worked at NPS Pharmaceuticals. From 2002 to 2008, he worked at Aventis/Sanofi Pharmaceuticals. Dr. Garceau currently serves on the board of directors of EnteraBio Ltd. He holds a B.S. from Fairfield University and an M.D. from University of Massachusetts Medical School.
DIRECTOR / INDEPENDENT
Dr. Hans-Juergen Woerle has more than 20 years of international health care experience in academic nutraceutical research and pharmaceutical drug development. He has served as a member of Enterome’s board of directors since 2019.
Prof. Dr.-med. Woerle has developed several preclinical molecules towards Proof of Concept in humans and has led the development of eight new products through international registration and commercial launch.
Prof. Dr.-med. Woerle has received intensive training in clinical medicine with an in-depth and broad education in internal medicine. He has three years of intensive care/emergency medicine; hospital-based training in diabetes/endocrinology, cardiology, which together with his longstanding research activities has allowed him to make a significant contribution to the field of cardio-renal-metabolic research and drug development.
Prof. Dr.-med. Woerle is a member of the executive leadership team of Nestle Health Science setting the corporate research and development strategy for its nutritional health products.
DIRECTOR / NESTLÉ
Johan Kördel has served as a member of Enterome’s board of directors since 2012 and has served as representative of Lundbeckfonden Invest A/S, the legal entity that holds this board seat, since 2017.
Dr. Kördel has served as the Senior Partner at Lundbeckfonden Ventures since 2010. Before joining Lundbeckfonden Ventures, Dr. Kördel worked 20 years in the pharmaceutical and biotech industry with structural biology, management of research and early development, portfolio management, business development and alliance management. From 2008 to 2010, Dr. Kördel served as Co-Founder and Chief Executive Officer of Sound Biotech ApS. From 2001 to 2006, he served as Co-Founder and Senior Vice President of Research and Business Development of Biovitrum AB. From 1992 to 2000, Dr. Kördel worked at the pharmaceutical company, Pharmacia Corporation.
Dr. Kördel trained as a physical chemist at University of Lund, Scripps Research Institute and Harvard Medical School. Since 1994, Dr. Kördel has been an associate professor of Physical Chemistry at the University of Lund.
DIRECTOR / LUNDBECKFONDEN VENTURES
Andrea Pederzolli has served as a member of our board of directors since March 2018 and has served as representative of Principia SGR SpA, the legal entity that holds this board seat, since June 2018.
Since 2017, Mr. Pederzolli has been a general partner at Principia SGR, a venture capital manager in Italy. Mr. Pederzolli started his career as an electronic engineer designing satellite communication networks and later moved to the financial sector working in London at the Industrial Bank of Japan (1994 to 1996), Barclays Capital (1997 to 1998) and Merrill Lynch (1998 to 1999). In 2000, he founded MangustaRisk. Mr. Pederzolli holds an M.Sc. in finance from the London Business School (UK) and an engineering degree in electronic engineering from the University of Rome (Italy).
DIRECTOR / PRINCIPIA
Mary Thistle has served as a member of our board of directors since 2017.
In January 2018, Ms. Thistle joined the Bill & Melinda Gates Medical Research Institute as the Chief of Staff and in November, 2020, she was appointed Special Advisor.. From 2015 to 2017, she served as the Chief Operating Officer at Dimension Therapeutics, Inc. From 2009 to 2015, Ms. Thistle served in several roles at Cubist Pharmaceuticals Inc., including as Senior Vice President, Corporate Development and Integration Management. Prior to this, from 1997 to 2008, she held leadership positions at ViaCell, Inc.
Ms. Thistle is currently a member of the board of directors for Homology Medicines, Inc. where she is the chair of the audit committee. Ms. Thistle is also on the board of directors for Ziopharm Oncology, Inc and Cocoon Biotech, Inc. Ms. Thistle began her career in finance as a certified public accountant working with both private and public companies. She received her B.A. in accounting from the University of Massachusetts.
DIRECTOR / INDEPENDENT
Enterome’s ability to generate unrivalled insights into the Microbiome-Human Health Axis, has enabled it to generate a range of next-generation therapeutics.
Enterome has two unique platforms that are generating highly promising drug candidates:
Enterome is developing an innovative, microbiome-based approach for the development of therapeutic cancer therapies using its OncoMimics platform.
The gut is the largest lymphoid organ in the body with >70% all T-cells and is home to the vast majority of memory T-cells. Therefore, there is an on-going interaction between the microbiome and the immune system, resulting in a pool of memory T-cells against commensal bacterial antigens – this prevents bacteria escaping the gut environment and colonizing elsewhere in the body.
Enterome has discovered that some of these peptide antigens bear striking similarity to those present on multiple cancer types and can induce a targeted, anti-tumor response – hence “OncoMimics”.
Because of their bacterial origin, OncoMimic therapies elicit a significantly greater CD8+ T-cell driven immune response when administered with an adjuvant than the homologous human tumor antigens on their own.
Enterome has also demonstrated that this response is increased when combined with checkpoint inhibitors in vivo.
The company has filed several patents applications covering novel OncoMimics targeting most well-known and novel tumor antigens highly expressed in major tumor types.
Enterome has used these findings to discover and develop what it believes will be highly effective, potentially off-the-shelf immunotherapies against cancers with significant unmet medical need.
The Company’s lead immune-oncology candidate, EO2401, enter Phase 1b/2a clinical trials in patients with glioblastoma and in patients with adrenal malignancies in July and September 2020, respectively.
Entereome’s second OncoMimic candidate EO2463 is being prepared as a clinical candidate for B-cell malignancies.
Gut bacteria are also capable of producing peptides/proteins that mimic the effect of human peptides/proteins, such as hormones.
Enterome’s next-generation EndoMimics platform is being used to generate precision drugs by using this natural reservoir of thousands of safe and tolerized human-like effector proteins/ hormones that are produced by the gut bacteria.
The EndoMimics platform enables Enterome access to an unrivalled source of a completely new generation of microbiome-derived biologics targeting unmet needs in inflammation, diabetes, obesity and IBD.
EM101 is the first EndoMimic candidate we are advancing in IBD – it is a mimic of a human protein that targets IL-10, a key point in the inflammation pathway.
These two highly productive platforms have been created using Enterome’s world leading Metasecretome technology.
The technology enables a full genomic and functional analysis of the gut microbiome and provides an unrivalled ability to generate precision drugs by using the natural reservoir of thousands of safe and tolerized effector proteins that are produced by the gut bacteria.
Enterome is developing an innovative, microbiome-based approach for the development of therapeutic peptide cancer therapies using its OncoMimics platform.
EO2401 is an innovative, off-the-shelf immunotherapy discovered by Enterome.
EO2401 comprises three OncoMimics, which are strongly homologous but not identical to three key tumor antigens that are highly expressed in human malignancies, including glioblastoma (GBM) and adrenal tumors.
Two Phase 1b/2a clinical trials investigating EO2401 in combination with a checkpoint inhibitor for the treatment of glioblastoma (ROSALIE study, NCT04116658) and of adrenal tumors (SPENCER study, NCT04187404) were initiated mid2020.
EO2463 comprises OncoMimics that are highly expressed on B-cell malignancies.
With EO2463, Enterome aims to induce a highly specific cytotoxic immune reaction against B lymphocytes, and to target the malignant B cells which are enriched in patients with B-cell Non-Hodgkin lymphomas and leukemias.
EO2463 is being prepared as a clinical candidate for trials to start in 2021.
INFLAMMATORY AND METABOLIC DISEASES
Enterome is developing a new generation of microbiome-derived biologics from its proprietary EndoMimics platform to treat inflammatory and metabolic diseases. EM101 is the first candidate to emerge from this platform and is designed to target IL-10, a key intervention point in the inflammatory cascade, for the treatment of Inflammatory Bowel Disease (IBD). First clinical trial with EM101 is expected to start in 2022.
Sibofimloc (also called EB8018 and TAK-018) is a first-in-class, orally administered small molecule that is specifically designed to reduce the inflammatory cascade underlying Crohn’s disease and remain gut-restricted, to minimize absorption into the bloodstream.
It is designed to reduce inflammation by preventing:
- FimH-expressing bacteria from adhering to the gut wall,
- Activation of innate immune receptors,
- Induction of gut permeability, and
- Ultimately, inhibiting bacterial translocation through the gut wall
Enterome believes that sibofimloc has the potential to treat patients with various subsets of IBD, including Crohn’s disease, as well as in different therapeutic settings, such as patients with chronic active disease or requiring a maintenance therapy to maintain remission after surgery or other active therapy.
Sibofimloc is advancing through Phase 2 clinical trials in Crohn’s disease under a co-development and co-commercialization partnership with Takeda.
Enterome was established in 2012 and has raised close to €100 million in financing rounds with private equity funds (and strategic investors) and in loans.
ENTEROME IS GROWING, APPLY TODAY AND BECOME A PART OF OUR SUCCESS!
We are an innovation-driven company with a strong team spirit as well as a great place to work where you can get things to move.
Working in lean teams for a human-size company, you will get a real mission with objectives to fulfil : flexibility and scope of action is wide, and learning becomes a daily routine.
Also, you will get a chance to quickly take ownership and increase your responsibilities.
The solutions we deliver are the sum of our collective talents, and we believe the best results arise from integrating a mix of perspectives and experiences.
Furthermore, as you get involved and enjoy what you do, we make sure you get recognition for your achievements.
We need enthusiastic and passionate new hires to take on challenges and develop our business.
If you wish to acquire key competencies and to develop them, Enterome is the place to be.
If you have a positive, proactive, startup mentality, and are interested in joining a highly disruptive life science business on the forefront of the burgeoning microbiome industry:
ENTEROME WANTS AND NEEDS YOU!
We are currently expanding our Immuno-Oncology department and are looking for new talented people to join our team from leadership positions to research and development functions.
Apply now and become part of an amazing adventure in Life Sciences at Enterome.