Product Dev Landscape

‘1805

Revolo 1805

Potential Platform to Treat Multiple Autoimmune Diseases

‘1805 is a modified analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP), a key player in immune function that resets the immune system for long-term disease remission. Its mechanism of action creates vast optionality across multiple indications and routes of administration.

We are developing ‘1805 for the treatment of patients with moderate to severe rheumatoid arthritis (RA) and non-infectious uveitis (NIU) while exploring additional indications.

Rheumatoid Arthritis

RA is a chronic inflammatory disease that is currently one of the largest therapeutic segments worldwide, affecting roughly 1.3 million people in the US alone.1

Steroids, immunosuppressants, and biologics are available, but these treatment options suppress the immune system,2 putting patients at risk of serious infections and other complications. Additionally, 60 to 70% of patients do not achieve remission,3 and ~20% of patients do not respond4 to available therapies.

Patients with RA need improved therapies that achieve long-lasting remission without unwanted side effects.

In preclinical models, ‘1805 demonstrated long-term anti-inflammatory and immunomodulatory effects.5 Data from a Phase 2 trial6 investigating ‘1805 in 24 patients with severe RA nonresponsive to standard of care demonstrated its potential as a safe and effective treatment for RA, including rapid onset (week 3) and sustained remission (12 weeks) following a single intravenous dose.

A Phase 2 trial investigating ‘1805 as a potential treatment for patients with moderate to severe RA is in preparation.

Non-infectious Uveitis (NIU)

NIU, or inflammation of the inside of the eye, is a leading cause of adult blindness in western countries,7 affecting about 300,000 patients annually8 in the US. Untreated, NIU can cause vision loss in up to 40% of patients, interfering with productivity and negatively impacting quality of life.

Out of the approximately 100,000 patients with NIU treated every year, roughly 50% are nonresponsive to the only approved biologic. Steroids remain the mainstay of therapy but can lead to unwanted ocular and systemic side effects. Most patients are unable to achieve long-term disease remission with available treatments.

A Phase 2 trial investigating ‘1805 as a potential treatment for patients with NIU is expected to start soon.

REFERENCES

  1. Helmick CG, Felson DT, Lawrence RC, et al; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15-25.
  2. American Academy of Allergy, Asthma & Immunology. Immunosuppressive medication for the treatment of
    autoimmune disease. https://www.aaaai.org/conditions-and-treatments/related-conditions/
    immunosuppressive. Accessed April 5, 2021.
  3. Brown PM, Isaacs JD. Rheumatoid arthritis: from palliation to remission in two decades. Clin Med (Lond).
    2014;14(suppl 6):s50-s55.
  4. de Hair MJH, Jacobs JWG, Schoneveld JLM, van Laar JM. Difficult-to-treat rheumatoid arthritis: an area of unmet
    clinical need. Rheumatology (Oxford). 2018;57(7):1135-1144.
  5. Brownlie RJ, Myers LK, Wooley PH, et al. Treatment of murine collagen-induced arthritis by the stress protein
    BiP via interleukin-4-producing regulatory T cells: a novel function for an ancient protein. Arthritis Rheum.
    2006;54(3):854-863.
  6. Kirkham, B et al. 2016. Safety and patient response as indicated by biomarker changes to binding
    immunoglobulin protein in the phase I/IIA RAGULA clinical trial in rheumatoid arthritis. Rheumatology, vol 55 (11):
    1993–2000.
  7. Rosenbaum JT, Bodaghi N, Couto C, et al. New observations and emerging ideas in diagnosis and management
    of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445.
  8. Thorne JE, Suhler E, Skup M, et al. Prevalence of noninfectious uveitis in the United States: a claims-based
    analysis. JAMA Ophthalmol. 2016;134(11):1237-1245.
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Glen Giovanetti

Non-Executive Director

Glen Giovanetti has more than 35 years of experience in strategy and operational leadership in the life science industry as well as in financial governance, risk and reporting as EY’s Global Biotechnology Sector Leader and Life Sciences Sector Leader. He currently serves on the Board of Directors of Life Science Cares, Teon Therapeutics and XW Pharma.

Marla S. Persky

Non-Executive Director

Marla S. Persky currently serves as the chief executive officer and president of WOMN LLC. She has more than 25 years of international senior business and legal experience in the pharmaceutical industry having held numerous business and legal positions at Boehringer Ingelheim and Baxter International. She currently serves on the Boards of Directors of Xeris Pharmaceuticals, YGEIA Consulting Group, Primary Stages, World Neighbors and A Better Chance in Ridgefield.

Dora Rau

Senior Vice President, Quality

Dora Rau brings 25 years of experience in development and commercial operations for drugs, biologics, devices and combination products to the team. She has held numerous executive-level quality positions, with expertise in building quality systems and in leading teams to attain successful regulatory authority inspection outcomes and product approvals.

Jonathan Gold

Chief Financial Officer

Over the last 25 years, Jonathan Gold has been an institutional venture capitalist, a public fund manager, a founder, an operating executive, and a board member for companies across sectors including life sciences. In those roles, he was active in the development, financing and mergers and acquisitions for numerous public and private companies.

Team Members

Michael Albisser

Non-Executive Director​

Michael is a partner of Metellus, a Zurich and London-based venture capital firm investing in technology and life sciences with ground-breaking potential. Having more than 25 years of experience in the finance area he is responsible for finance, tax, and deal structures. He serves on the board of various venture-backed companies.

Dr. Isaac Cheng, m.d.

Non-Executive Director

Dr. Isaac Cheng is currently an investment professional at Morningside, a venture capital and private equity institution based in Boston USA, and Shanghai China. Dr. Cheng focuses primarily on biopharmaceutical and healthcare investments. He has served on numerous public and private company boards.

Peter Greenleaf

Chairman

Peter Greenleaf currently serves as the chief executive officer (CEO) and member of the Board of Directors of Aurinia, (NASDAQ: AUPH / TSX: AUP), an autoimmune therapeutics company. He has held several other CEO and chairman roles. He is also currently a member of the Board of Directors of Antares Pharmaceuticals, Inc. (NASDAQ: ATRS) and Chairman of the Board of Directors of Biodelivery Sciences International, Inc. (NASDAQ: BDSI).

Marylyn Rigby

VP of Marketing and Investor Relations

Marylyn Rigby is an experienced pharmaceutical, biotech, and drug delivery professional. In addition to her expertise in marketing, public and investor relations, she has a successful track record with business development, licensing, public and private equity financing, strategy and other key corporate functions.

Nancy Vinh

VP of Clinical Operations

Nancy Vinh brings over 20 years of experience in managing early and late phase, international clinical trials for drugs, biologics, cell therapy and combination products across a wide range of therapeutic areas to the team. She has served as head of clinical operations and led registrational and label expansion trials execution.

Team Members

Dr. Clare Burgess

Chief Development Officer

Dr. Clare Burgess has 24 years of experience in clinical drug development as a pharmacologist and has worked across a wide range of therapeutic areas within the pharmaceutical industry. She has held multiple leadership roles and has led multidisciplinary teams across the world.

Jeff Myers, m.d., ph.d

Chief Medical Officer

Jeff Myers, M.D., Ph.D., has 20 years of experience in medical affairs, regulatory and clinical development within the biopharmaceutical industry, with focuses on cardiovascular, pulmonary, oncology, and inflammatory diseases.

Before entering the industry, he practiced as a congenital cardiac surgeon and served as the chief of pediatric cardiac surgery at Massachusetts General Hospital and as Associate Professor of Surgery at Harvard Medical School.

Team Members

Dr. Roly Foulkes

Chief Scientific Officer

A true drug discoverer, Dr. Roly Foulkes has 25 years of experience building and delivering innovative therapeutic portfolios within the immunology and inflammatory disease space. He has a strong record advising small and medium sized immunology biopharma companies in developing competitive therapeutic strategies and bringing new innovative molecules to the clinic.

Team Members

Jones w (woody) Bryan, ph.d.

Chief Business Officer

Jones (Woody) Bryan, Ph.D., brings almost 30 years of experience in the healthcare industry to the team, having led successful business development operations in both private and public pharma and biotech companies.

Team Members

Perry Calias, ph.d.

Chief Operating Officer

Perry Calias, Ph.D., brings over 25 years of experience in pre-clinical and clinical development, CMC and global regulatory submissions across the drug and device sectors of healthcare. He has held numerous executive positions leading clinical and non-clinical operations, with a strong focus on diseases of the central nervous system and rare diseases.

Team Members

Jonathan Rigby, mba

Group Chief Executive Officer

As employee #1 of Revolo Biotherapeutics in the US, Jonathan Rigby has led the company through substantial and rapid growth. He brings three decades of experience creating value and opportunities for companies in the pharmaceutical, biotech and drug delivery technology industry.

Team Members
  • Carrie Vincent: Director, HR & Senior Executive Administration
  • Dr. Jones W. (Woody) Bryan: Chief Business Officer
  • Dr. Roly Foulkes: Chief Scientific Officer
  • Jonathan Gold: Chief Financial Officer
  • Jeff Myers, MD: Chief Medical Officer
  • Marylyn Rigby: VP Marketing & Investor Relations
  • Dr. Perry Calias: Chief Operating Officer