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Revolo Biotherapeutics Presents New Data for ‘1805 in Inflammatory Bowel Disease and Rheumatoid Arthritis at the 5th Treg Directed Therapies Summit

Data demonstrates the potential of ‘1805 to reset the immune system through its unique mechanism of action across various autoimmune diseases, including inflammatory bowel disease and rheumatoid arthritis

NEW ORLEANS and CAMBRIDGE, UK, June 5, 2023 – Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced new pre-clinical and ex-vivo data in an oral presentation at the 5th Treg Directed Therapies Summit, showcasing the ability of its immune-resetting drug candidate ‘1805 to alter the T regulatory cell (Treg) phenotype, gene expression and inflammation in human gut tissue with inflammatory bowel disease (IBD) as well as selectively alter transcripts in macrophages harvested from rheumatoid arthritis (RA) subjects.

“This compelling data shows that ‘1805 enhances CD69+ and CD39+ Tregs in human tissue afflicted with IBD and improves anti-inflammatory gene transcription. This further illustrates ‘1805 unique mechanism of action as it resets the immune system to restore immune system balance,” said Jonathan Rigby, Chief Executive Officer of Revolo. “Additional data for ‘1805 in immune cells harvested from patients with RA showcases the selective alteration of RA cell transcripts compared to controls. Altogether, this data supports our upcoming Phase 2 trial in RA as well as future efforts in ulcerative colitis and other IBD indications. We are eager to continue exploring the broad potential of ‘1805 in various indications with the goal of providing long-term disease remission in patients living with autoimmune diseases.”

Data highlights include:
Inflammatory Bowel Disease

  • Enhanced generation of double positive CD69+/CD39+ FoxP3 Tregs in the inflamed lamina propria of gut biopsies from IBD patients following treatment with ‘1805 while non-inflamed tissue biopsies did not.
  • In mononuclear cultures, ‘1805 sustains an increase in CD69 expression on Tregs as well as that of its ligands, galectin-1, and S100A8/9. When CD69 binds to its ligands, the JAK/STAT5 pathway is activated to promote Treg differentiation and prevent pro-inflammatory Th1/Th7 cell generation.
  • CD69+/CD39+ Tregs in intestinal tissues may play an important role in immune system balance and the prevention of inflammation.

Rheumatoid Arthritis

  • Following treatment with ‘1805, macrophages harvested from RA subjects experienced a selective reduction in pro-inflammatory gene transcripts in comparison to healthy controls which showed very little alteration in transcripts.
  • In macrophages from RA subjects, ‘1805 upregulated ~1900 genes involved in cell contact and downregulated ~1550 genes involved largely in hypermetabolic changes. Macrophages from healthy donors showed little change in gene transcripts after treatment with ‘1805.

About ‘1805
‘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.

Revolo Biotherapeutics
Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, without the immune system suppression seen with current therapies. Its two drug candidates, ‘1805 and ‘1104, a protein and a peptide respectively, reset the immune system to prevent the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1104 is a peptide derived from a natural immune-regulatory protein and has recently completed two Phase 2a clinical trials for patients with eosinophilic esophagitis (EoE) and allergic disease. The disease-agnostic mechanism of action of Revolo Biotherapeutic’s assets provides a potential platform for the development of treatments for multiple autoimmune and allergic diseases.

For further information, please visit www.revolobio.com.

Company Contact
Marylyn Rigby, SVP Investor Relations & Marketing
mrigby@revolobio.com

Media Contact
Monica Rouco Molina, Ph.D.
LifeSci Communications
+1-929-469-3850
mroucomolina@lifescicomms.com

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David Southwell

Chairman

In addition to his role as Chairman of Revolo, David Southwell serves on the Board of Directors for Rocket Pharmaceuticals and PTC Therapeutics. David is the former CEO of TScan Therapeutics. Before that, he served as President and CEO of Inotek Pharmaceuticals until its merger with Rocket Pharmaceuticals in 2018. David has held other senior leadership roles and Board of Director positions at companies including Human Genome Sciences, Sepracor, Spero Therapeutics, inVentiv Health, and THL Credit.

Tunde Otulana, M.D.

Non-Executive Director

Tunde is currently the Chief Medical Officer of Veloxis Pharmaceuticals in North Carolina, USA since August 2020. Prior to Veloxis he was Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals. His career, which spans about 30 years in industry, government and academia, includes leadership roles at Boehringer Ingelheim Pharmaceutical Inc. and the US Food and Drug Administration (“FDA”). Tunde is a physician trained in Pulmonary and Critical Care Medicine.

Beth Alley

Vice President, Regulatory Affairs

Beth Alley has over 20 years of experience within the biopharmaceutical industry in regulatory affairs, commercial strategy, and medical writing throughout all phases of drug development. Her primary areas of focus have been in development of biologics for treatment of autoimmune, inflammatory, and infectious diseases.

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

Non-Executive Director

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

SVP 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

SVP 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.

President & Chief Executive 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

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