ENDOGENA THERAPEUTICS

is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Our approach has the potential of a paradigm shift to treat degenerative conditions related to aging and genetic disorders.

Technology

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the vision

Endogena Therapeutics’ approach for endogenous regenerative medicine will result in a novel treatment paradigm for common degenerative diseases that are becoming more prevalent due to demographic changes.

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the mission

Endogena Therapeutics is focusing its drug discovery and development efforts on indications with high unmet medical needs.

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endogenous regeneration meets small-molecule medicine

Recent discoveries in stem cell biology together with technological advances for phenotypic, functional screening, have unlocked our ability to harness the potential of adult stem- and progenitor cells. Our novel drug discovery approach is based on the concept of selective regulation of these endogenous cells for controlled tissue repair by small molecules.

Pipeline

In our most advanced programs, we are targeting degenerative diseases of the eye, including retinitis pigmentosa, which progressively leads to complete loss of vision – our pioneering approach enables the discovery of breakthrough therapies based on cutting-edge knowledge of molecular pathways that regulate retinal stem cells and retinal pigment epithelial cells, which nourish the eye’s photoreceptors and retina.

Discovery

Lead Optimization

IND-Enabling

Phase I / IIa

Phase IIb

Phase III

Age-related macular degeneration
Idiopathic pulmonary fibrosis
FDA ODD & FAST TRACK

Discovery

Lead Optimization

IND-Enabling

Phase I / IIa

Phase IIb

Phase III

Retinitis pigmentosa
FDA ODD & FAST TRACK
age-related macular degeneration
idiopathic pulmonary fibrosis

Retinitis pigmentosa (RP)

is a group of inherited diseases causing slow and progressive retinal degeneration and loss of vision. Collaborating with leading vitreoretinal specialists and experts in the ophthalmology field, in our most advance program we have initiated clinical studies of our novel treatment paradigm in 2022.


Age-related macular degeneration (AMD)

is a leading cause of irreversible vision loss in the developed world and it has been estimated that almost 9% of the population older than 45 years of age are affected. Dry-AMD is associated with atrophic cell death of the central retina or macula and it accounts for 80-90% of the AMD population.

Idiopathic pulmonary fibrosis (IPF)

is a chronic and progressive lung disease, characterized by inflammation and subsequent scarring of the lung that leads to respiratory failure. It is a rare, age-related condition with unknown cause. Every year, 10 out of 100,000 people are diagnosed with this disease, with life expectancy of 3-5 years. Up to date, existing medications only slow down disease progression, therefore there is an urgent need to develop new, more effective and well tolerated drugs for IPF patients.

News

Press

Erste Studie gibt Hoffnung: Schweizer Forscher macht Blinde sehend

15. Februar 2024
Bislang lässt sich vererbte Blindheit kaum behandeln. Jetzt gibt es Hoffnung: Ein Schweizer Biotech-Unternehmen hat eine neue Therapie entwickelt – die erste klinische Studie an Menschen ist vielversprechend.

Blick: GESELLSCHAFT

Small-Molecule-Directed Endogenous Regeneration of Visual Function in a Mammalian Retinal Degeneration Model

26 January 2024
This groundbreaking study, done in collaboration with our University of Toronto partners, demonstrates the potential of a small molecule to stimulate endogenous regeneration in the eye to restore vision.
This study represents a pivotal milestone in revolutionizing the treatment of vision impairment and reflects Endogena’s commitment to pioneering solutions for degenerative diseases and improving patient outcomes worldwide.

International Journal of Molecular Sciences

OIS Podcast Ep #381
20 October 2023
In this episode of the Ophthalmology Innovation Source (OIS) podcast, CEO Matthias Steger, PhD, MBA, sat down with retina specialist Firas Rahhal, MD, to discuss the Endogena approach in depth.

Interview OIS Podcast

Running on resilience: Lessons in stamina from pushing your limits
15 June 2023
Endogena Therapeutics CEO Matthias Steger explains how long-distance running helped him to found Endogena and develop resilience

LinkedIn article

Retinal Regeneration
10 May 2023
Endogena Therapeutics CEO Matthias Steger discusses fast track FDA approval for EA-2353, a new drug for the treatment of retinitis pigmentosa

Interview the Medicine Maker

Endogena – full enrollment for retinitis pigmentosa trial
4 May 2023

Endogena Therapeutics Completes Enrollment Ahead of Schedule in its Phase 1/2a Trial of EA-2353 for Retinitis Pigmentosa.

Tweets

LinkedIn

Endogena – completed dose escalation study
5 April 2023

Endogena Therapeutics Completes Dose Escalation in the Phase 1/2a Clinical Trial of EA-2353 for the Treatment of Retinitis Pigmentosa

Tweets

Inherited blindness is almost impossible to treat
27 November 2022

Now there is hope – even if the project of Matthias Steger’s Swiss biotech company still sounds futuristic.
PDF (Translated from the Sonntags Blick-Magazin)

Zwischen Science-Fiction und biblischem Wunder
Vererbte Blindheit lässt sich kaum behandeln. Nun gibt es für Betroffene Hoffnung – auch wenn das Vorhaben eines Schweizer Biotech-Unternehmens noch nach Science-Fiction klingt.

Originalartikel: blick.ch

People

We work well together, and it shows. We are driven from within, which is in itself – endogenous. Our passionate team loves to discover and develop. Science is at the heart of everything we do and helps us to pursue our purpose.

TEAM

Board

Endogena’s leadership team is actively supported by a highly knowledgeable Board of Directors with extensive experience in the healthcare industry and capital markets.

Founders

Driven by their vision of a new drug discovery platform with the aim to repair damaged tissue by activating the body’s innate regenerative ability, combining artificial intelligence with decades of drug discovery expertise to identify small molecules to specifically activate endogenous progenitor/stem cells, Matthias Steger and Gisbert Schneider founded Endogena Therapeutics, Inc. in August 2016.

Prof. Dr. Gisbert Schneider

PhD
Co-Founder / ETH Zürich

Investors

Endogena’s shareholders include two anchor investors and a small group of individual investors whose combined support and commitment over the years has been the cornerstone of our success.

Rejuveron Life Sciences AG is a Swiss integrated biotechnology platform company that develops and invests in drugs and technologies which have the potential to improve longevity. As well as providing startup-coaching and incubator lab space, they provide direct investment in promising means to improve health aging, with the ultimate goal of increasing human healthspan.

Website: Rejuveron Life Sciences AG

DEFTA Partners is a technology venture capital firm founded in the 1980s and has offices in San Francisco and Tokyo – DEFTA Healthcare Technologies, the firm’s newly formed fund, invests in seed and early stage companies developing advanced therapeutics and digital health in the USA, Japan, Israel, and beyond – the current investments in healthcare include endogena therapeutics, Orig3n, Two Pore Guys, Lifeguard Health Networks, and Graftworx. DEFTA Partners also supports the annual World Alliance Forum in San Francisco, a premier, international conference focused on game changing healthcare innovations and technologies.

Website: DEFTA Partners

The Centre for Commercialization of Regenerative Medicine (CCRM) is a not-for-profit, public-private consortium supporting the development of foundational technologies that accelerate the commercialization of cell and gene therapies, and regenerative medicine technologies.
These technologies have the potential to transform health care, with the promise to treat, manage and perhaps cure some of the most debilitating and costly diseases in the world today. However, many new potentially life-changing cell, gene and regenerative medicine-based treatments never reach patients because they are not successfully moved from the laboratory to the clinic.
Canadian scientific excellence in stem cells, bioengineering and biomaterials combined with existing infrastructure positions CCRM to coordinate product development and commercialization in a capital-efficient manner.

Website: The Centre for Commercialization of Regenerative Medicine (CCRM)

Partners

CLINICAL ADVISORS

Endogena is fortunate to have clinical advisors who are at the forefront of ophthalmology, ensuring the successful planning and implementation of Endogena’s programs throughout clinical development.

SCIENTIFIC ADVISORS / PARTNERS

Endogena’s scientific advisors are scientists, physicians and industry experts who are international key opinion leaders in their fields. They support Endogena’s portfolio programs by providing strategic advice and critical scientific insights.

Prof. Pete Coffey

PhD
UCSB / UCL/ Moorfield Eye Hospital

Prof. Andreas Günthe

Prof. Micha Drukker

PhD
Stem Cell Biology

Prof. Dr. Gisbert Schneider

PhD
Co-Founder / ETH Zürich

Prof. Derek van der Kooy

PhD
University of Toronto

Careers

open positions

We have currently no open positions

expanded policy access

Endogena Therapeutics is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.

Consistent with Endogena Therapeutic’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe, and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.

However, at the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. Because the safety and efficacy of our investigational drugs have not been fully established, Endogena Therapeutics does not normally offer access to our investigational drugs outside of our clinical trials, but rather encourages patients to discuss with their physicians about other disease management options.

On an exceptional basis, Endogena Therapeutics will consider providing a requesting physician with pre-approval access to a specific Endogena Therapeutic investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

  • The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
  • The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
  • A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
  • The ability of the requesting physician to adequately communicate to the patient the potential risks and benefits of the proposed use of the investigational drug so that the patient can provide informed consent and the willingness of all parties to sign a release;
  • The commitment of the requesting physician to obtain all necessary regulatory and ethical approvals;
  • The likelihood that regulatory authorities and institutional review boards will review and approve expanded access for the patient in a timely basis;
  • Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access;
  • Adequate supply of the investigational drug is available;
  • Other factors we may deem appropriate.

We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Endogena Therapeutics is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Endogena Therapeutics may require more detailed information to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Endogena Therapeutics whose decisions are final.

Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to clinical.studies@endogena.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 10 business days after receipt.

Mike Tanji

Mike Tanji is an esteemed board member with a distinguished career that spans multiple industries and includes significant experience in the Asian market and in the global market. Starting his journey at The Long-Term Credit Bank of Japan, Ltd. (LTCB), followed by the secondment to the Ministry of International Trade and Industry in Japan, Mike gained invaluable expertise in the financial sector. Subsequent to his time at LTCB, he held key positions, including Senior Consultant at Jomon Associates, Executive Assistant to the President at Shin Ginko Tokyo Co., Ltd., and Senior Managing Executive Officer at Aruze Corporation. With an in-depth understanding of the Asian and global markets, Mike played a crucial role in supporting corporate customers’ entry into Asian countries as well as management in the global market. Currently, he serves as the COO of DEFTA Partners and the President & CEO of Bacchus Bio Innovation Co., Ltd., leveraging his regional and global knowledge to drive growth and forge strategic partnerships. Mike’s role as a Director at the Alliance Forum Foundation showcases his commitment to initiatives promoting positive social and economic progress.

With a Juris Doctor degree and a Directorship at Japan Initiative, complemented by his global market experience, Mike brings a diverse skill set to his board position. His breadth of knowledge and strategic acumen make him a vital asset to our organization.

Manfred Schneider

Manfred Schneider is a certified toxicologist and ADME/PK specialist with almost 25 years of broad-based experience in various fields of pharmaceutical R&D. Since 2013, he is a consultant for several large and small pharmaceutical companies with a strong proven track record, in particular, >10 recent successful small-molecule nonclinical safety packages and the subsequent bioanalytical and PK evaluation of the clinical trials up to Phase II.

Manfred received his PhD in Chemistry from the University of Ulm in Germany and holds a US board certification as toxicologist (DABT). Following a molecular toxicology postdoc at UC Berkeley, Manfred worked at Tularik, Forest Laboratories, was head of early ADME at Merck Serono, and head of DMPK & TOX at Addex.

Moreno Menghini

PD Dr. med. Moreno Menghini is a vitreoretinal specialist with research background in medical retina and imaging. He studied medicine at the University of Zurich, Switzerland, where he gained his MD. Moreno’s clinical training was undertaken at the University Hospital of Zurich, and the Cantonal Hospital of Lucerne, Switzerland. In 2012 he was awarded the George and Rosalie Hearst Fellowship at the University of California, San Francisco, USA to undertake a clinical fellowship under the mentorship of Professor Jacque Duncan. Thereafter he worked for a Swiss private eye clinic before having been granted 2016 the position of vitreoretinal fellow at Sir Charles Gairdner Hospital in Perth, Australia, where he trained under the supervision of Professor Ian Constable. In 2019, Dr. Menghini completed an academic fellowship with focus on retinal gene therapy at the University of Oxford, UK under the mentorship of Professor Robert MacLaren. As an honorary clinical research associate of the University of Oxford, he continues to be involved scientifically through various joint collaborations. Through his continuous academic achievements Dr. Menghini has recently received the venia legendi at the University of Zurich, and holds the title of “Privat Dozent”. In January 2021, Dr. Menghini was nominated Head of Department of Ophthalmology at the Ospedale Regionale di Lugano, Switzerland, and is now also responsible for the ophthalmology teaching module at the medical school of the Università Svizzera Italiana (USI). Furthermore, Dr. Menghini is adjoint consultant ophthalmologist at the Eye Clinic of the Luzerner Kantonsspital (LUKS), Lucerne, Switzerland, where he holds a monthly retinal dystrophy and oculogenetics clinic.

Jason Charish

As Endogena Therapeutic’s Clinical Scientist, Jason Charish has experience managing the analysis, interpretation and presentation of clinical data from first-in-human trials, assisting in the design of future clinical trials and preparing scientific and regulatory documents key for moving projects forward. He is passionate about harnessing insights from translational research and applying them to the analysis and interpretation of disease biomarkers in clinical studies. Previously, as Head of in-vivo Pharmacology, Jason led the design, execution, and analysis of in-house pre-clinical studies together with managing outsourced activities with academic and CRO partners. His work helped advance candidate molecules towards the clinic and contributed to two successful IND applications and one fast-track designation approval.Prior to focusing on in-vitro and in-vivo proof-of-concept studies in drug discovery and development research, Jason received his MSc and PhD from the University of Toronto and did post-doctoral work at the University Health Network. He specialized in models of human diseases with a focus on the retina. His research has contributed to over 20 peer-reviewed publications in the fields of retinal disease, molecular biology, stroke, cancer, multiple sclerosis, COVID and brain/eye development

Daphna Mokady

Daphna Mokady is a science-innovation and results-driven professional with 15+ years of academic and industry experience in leading research projects in a broad spectrum of biomedical fields, including regenerative medicine, cancer research, neurodegenerative disease modelling, and microbiology. Her versatile experience enables her to promote innovative ideas and lead pioneering research with demonstrated results. Throughout her work, Daphna cultivated a network of successful collaborations with global pharmaceutical companies, top researchers, and key opinion leaders in various fields. She is a passionate advocate of gender equality in STEM and the founder and president of a Toronto-based initiative aimed at promoting women’s careers in all STEM disciplines up to the boardroom.

Daphna holds a PhD in Microbiology from Tel Aviv University and an MSc (summa cum laude) in Genetics from the Hebrew University of Jerusalem.

Michelle Widmann

Michelle Widmann has over 20 years of experience overseeing clinical trials. Her background includes experience working for CROs, large and small pharmaceutical/biotechnology companies and government funded research. She is a clinical leader with extensive experience in setting up and executing clinical trials. She has in-depth knowledge of drug development, class 2 and 3 devices and cosmetics. She has managed all phases (I-IV) of research including pre-clinical (bench research in the lab), pilot, pivotal, REMs, post approval commitments and cosmetic studies. She also possesses experience with face-to-face meetings with multiple divisions of the FDA and participated in successful clinical FDA inspections resulting in no Form FDA 483s. In addition, extensive experience in SOP development and building cross functional relationships (regulatory, program management, QA, CMC, non-clinical, marketing, commercial) and being recognized for building clinical affairs departments and teams from the ground up is one of her strengths. She is passionate about developing clinical departments that are efficient and audit ready and teams that are operationally sound and knowledgeable. Michelle holds a BA in Biology (pre-med) from the University of North Carolina at Wilmington. Her main therapeutic and experience is in ophthalmology, respiratory (inhaled products), gastrointestinal and infectious diseases.

Susanne Raab

Susanne Raab is an accomplished in vivo pharmacology leader in drug discovery and development research. She has a solid track record of successful contributions to the R&D pipeline, advancing projects through development to clinical proof of concept. Susanne has worked at Roche for over 17 years as in vivo pharmacologist as well as project leader in different therapeutic areas. Susanne was in charge of in vivo pharmacology in the ophthalmology group at Roche, whereby she advanced candidates to clinical proof of concept. She was further involved in the planning, leading and managing of outsourcing activities with CROs and academic collaborators worldwide.

Susanne holds a MSc and PhD in Agricultural Biology from the University of Hohenheim in Germany and a Diploma in Medicines Development Sciences. Her main research focus lies on ophthalmological, cardiovascular and metabolic diseases.

Richard Pollot

Mr. Pollot is an accounting professional with more than 25 years of experience.  Mr. Pollot began his career in public accounting with EY where he spent 13 years serving clients, both public and private, in a variety of industries, including oil and gas, not-for-profit, healthcare and manufacturing.  After leaving EY as an Audit Senior Manager, Mr. Pollot served in various positions of increasing responsibility with Mustang Fuel Corporation, including Director of Exploration and Production Accounting.  Mr. Pollot then went on the serve as the Chief Accounting Officer of both White Star Petroleum as well as PetroShale, Inc.  Mr. Pollot has significant experience in operational and financial reporting, selection and implementation of accounting information systems, staffing and development of accounting teams, and development and application of accounting policies and procedures.  Mr. Pollot is a CPA and holds a Bachelor of Business Administration in Accounting from the University of Oklahoma.

Sonja Rossteuscher

Sonja is Founder and Managing Partner at No Limits Mentoring Coaching & Advisory, her own advisory firm specialized in executive coaching, and finance and leadership advisory and training mandates.   Most recently she was CFO at Rock Tech Lithium Inc., a TSX venture listed company in the lithium space.  Prior to that she held various positions as Chief Financial Officer and Managing Director, including at Tristone Flowtech Group, MKOPA Group and ADC African Development Corporation KGaA.   She has 25 years’ experience in finance, strategy and business management in Germany, Canada, Asia, and sub-Saharan Africa, and close to 15 years in a CFO function.  Sonja studied Business Administration at the University of British Columbia in Canada and completed her MBA at the University of St. Gallen (HSG) in Switzerland, where she is also currently involved in teaching at the Executive School.   She is currently non- executive director at Applicita Ltd. and Endogena Therapeutics.

Dan Zabrowski

Dan is a part-time Venture Partner at Decheng Capital.  Prior to joining Decheng, Dan worked over 20 years for Roche in a number of key global leadership positions, including Global Head of Regulatory Affairs, Global Head of Development Operations, Global Head of Roche Pharma Partnering, President of Ventana Medical Systems and President of the Roche Sequencing Unit. During his tenure in Business Development and Diagnostics, Dr. Zabrowski and his teams delivered 300+ acquisition and partnership deals. In addition, he was Board member of Chugai Pharmaceuticals. Prior to joining Roche, Dan worked at Syntex, Fujisawa (now Astellas) and G.D. Searle in their pharmaceutical R&D organizations and served as Adjunct Assistant Professor at the School of Pharmacy, University of Illinois — Chicago.

Dan received his PhD in Organic Chemistry from Indiana University, Bloomington and his BA degree in Chemistry from Saint Louis University.

Caleb Morgret

Caleb is a seasoned finance professional with over 20 years of international finance experience across multiple sectors and geographies. He has worked in CFO roles in the US as well as investment banking in Europe, having started his career at JP Morgan. He is the former CFO of Lucero Energy, a US-based, Canadian-listed public energy company as well as the former CFO of a private equity-backed energy company in the US. Additionally, he served as the treasurer for Nasdaq-listed Chesapeake Energy in the US. Over the course of his career, he has executed ~$30 billion of financings spanning numerous industries and markets (US, Europe, and Asia).

Dr. Aksana Labokha

Aksana brings over 15 years of international experience in the life sciences and healthcare sectors, specializing in early-stage business development, company building, and venture investments. At Rejuveron, Aksana plays a pivotal role in overseeing the company’s investment strategy, guiding its strategic growth, and expanding a portfolio of innovative therapies designed to address age-related diseases. Her leadership is instrumental in shaping the future of Rejuveron’s mission to advance healthcare solutions for aging populations.

matthias Steger

Matthias Steger’s long career in pharma and biotech began with F. Hoffmann-La Roche in 1999, when he worked in the design and synthesis of active molecules for a variety of therapeutic indications – next, he joined Axovan (later acquired by Actelion), where he built and implemented a new platform for orphan GPCR drug discovery – Matthias then branched out into investment banking at Kepler Equities before returning to Roche in 2007 – he became the firm’s global head of research and technology partnering, a role in which he investigated and managed more than 50 collaborations – in 2015 he followed his strong entrepreneurial instincts, first establishing SequelBlu, an independent advisory firm aimed at assisting companies with sustainable innovation, and then Endogena.
Matthias earned his MSc in organic chemistry and biochemistry at the University of Zurich, and his PhD in medicinal chemistry at the University of Sussex. In 2005 he completed an MBA at the University of St Gallen, where he was awarded Dean’s Honors.

 

Brian Ballios

MD PhD

Assistant Professor, University of Toronto Clinician-Scientist, University Health Network Staff Ophthalmologist, University Health Network, Sunnybrook Health Sciences Centre, and Kensington Vision & Research Centre Scientist, Krembil Research Institute

Sandrine Zweifel

PD Dr med FEBO
FMH Ophth / Ophth Surg

Vice Chair Department of Ophthalmology, University Hospital Zürich, University Zürich

Mark Pennesi

MD PhD FARVO

Kenneth C. Swan Endowed Professor of Ophthalmology
Professor of Molecular and Medical Genetics Chief, Paul H. Casey Ophthalmic Genetics Division Casey Eye Institute Oregon Health & Science University

Karl CsaKY

MD PhD

T. Boone Pickens Director
Molecular Ophthalmology Laboratory
Director, Clinical Center of Innovation for AMD
Chief Executive and Medical Officer
Retina Foundation of the Southwest

Giovanni Staurenghi

MD FARVO FEBO

Professor of Ophthalmology and Chairman of the University Eye Clinic
Director of the University Eye Clinic Department of Biomedical and Clinical Science Luigi Sacco Hospital, Milan

David Sarraf

MD

Clinical Professor of Ophthalmology, Stein Eye Institute, UCLA

Glenn yiu

MD PhD

Professor of Ophthalmology, University of California, Davis Health