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Pipeline

‘1104

Revolo 1105

Potential Platform to Treat Allergic Diseases

‘1104 was derived from a natural immune-regulatory protein, Mycobacterium tuberculosis Chaperonin 60.1, involved in resetting the immune system. It may provide remission for many allergic diseases. ‘1104 engages a novel target on macrophages and is a first-in-class modulator of the macrophage response. This response engages not only the effector arm of the immune system, but the regulatory arm as well.

We are developing ‘1104 for the treatment of patients with eosinophilic esophagitis (EoE) and other Th2 allergic diseases, including asthma and atopic dermatitis.

Eosinophilic Esophagitis

EoE is a progressive allergic disease characterized by difficulty swallowing (dysphagia) and gastric reflux as a result of elevated numbers of inflammatory immune cells, including eosinophils, in the walls of the esophagus. Roughly 180,000 children and adults in the US have EoE1, and up to 80% of patients have secondary allergic conditions.2 Early disease control is critical to avoid thickening of the tissue of the esophagus, associated with disease progression.

Current treatment options include dietary management and medications, such as steroids and biologics, that target inflammatory pathways after the immune system has been overactivated. Steroid treatments require frequent dosing and are often associated with unwanted side effects, such as immune suppression. While some existing treatments are able to reduce eosinophil levels and improve symptoms, they do not address the complex physiopathology of EoE and don’t work for everyone, leaving many patients in need of other options.

A Phase 2a clinical trial evaluating ‘1104’s efficacy, safety and tolerability showed a statistically significant improvement in patient-reported dysphagia symptoms compared to placebo. It also met its primary endpoint with a reduction in the eosinophil cell counts in the walls of the esophagus.3 The data confirmed ‘1104’s broad mechanistic effect across a range of key immune cell types associated with EoE, a key differentiator from other therapies. ‘1104 led to an increase in regulatory B cells (Bregs) and T regulatory cells (Tregs), which are key immune cells associated with immune suppression and self-tolerance. Additionally, ‘1104 caused a statistically significant reduction in pro-inflammatory CD4+ and CD8+ T cells and a normalization of 15 key EoE genes considered to affect remodeling, eosinophil and mast cell count, inflammation, cell adhesion, and the epithelium lining. Safety assessment showed no serious adverse events and there were no study drug discontinuations due to drug-related adverse events.

A Phase 2b trial investigating ’1104 in EoE is anticipated to begin in 2024.

Allergic Diseases

People with allergic diseases often experience symptoms even during treatment with currently available products. For more than 50 years, the number of people with allergic diseases has been rising and continues to climb.4

Recent clinical research across multiple allergic diseases has underscored the significance of targeting upstream pathways in the immune cascade, rather than focusing solely on single cytokines or immune cell types like eosinophils.

Given ‘1104’s immune resetting mechanism, antigen-agnostic nature, and clinical data observed in trials to date, we believe ‘1104 has the potential to work across a number of allergic disease indications beyond EoE.

‘1104 Potential in Allergic Diseases graphic

  • Asthma: There is a significant unmet need for the more than 25 million patients living with asthma in the U.S., including 1 million with uncontrolled moderate to severe Th2 and non-Th2 forms of the disease.5,6
  • Food Allergy: Approximately 26 million people in the US7 are affected by food allergies, highlighting the critical demand for new advancements and readily available treatments.
  • Atopic Dermatitis: An estimated 9 million individuals live with atopic dermatitis in the U.S.8,9, with many patients remaining untreated. Novel upstream mechanisms are crucial for addressing the needs of this patient population.
  • Other Eosinophilic Gastric Disorders: There is a pressing need for innovative treatments for the large number of patients suffering from other eosinophilic gastric disorders beyond EoE, many of whom are thought to be undiagnosed.
  • Other Th2 Diseases: Beyond asthma and atopic dermatitis, the development of novel therapies is essential for addressing the spectrum of Th2-driven diseases. This includes conditions such as chronic rhinitis with nasal polyps, chronic spontaneous urticaria, and prurigo nodularis.

A proof-of-concept Phase 2 study in an additional Th2 allergic indication will be started in 2024.

REFERENCES

  1. Moawad FJ. Eosinophilic esophagitis: incidence and prevalence. Gastrointest Endosc Clin N Am. 2018;28(1):15-25.
  2. Wechsler JB, Bryce PJ. Allergic mechanisms in eosinophilic esophagitis. Gastroenterol Clin North Am. 2014;43(2):281-296.
  3. Company press release: https://revolobio.com/2023/07/18/revolo-biotherapeutics-announces-additional-data-from-phase-2a-trial-of-1104-in-adults-with-active-eosinophilic-esophagitis/
  4. Pawankar R, Canonica GW, Holgate ST, Lockey RF, Blaiss MS, eds. WAO White Book on Allergy: Update 2013. Executive Summary. Milwaukee, WI: World Allergy Organization; 2013. https://www.worldallergy.org/UserFiles/file/ExecSummary-2013-v6-hires.pdf. Accessed May 4, 2021.
  5. Centers for Disease Control and Prevention. Uncontrolled Asthma in Adults. Accessed on February 6, 2024:  https://www.cdc.gov/asthma/asthma_stats/uncontrolled-asthma-adults.htm
  6. Holgate S, Wenzel S, Postma D, et al. Asthma. Nat Rev Dis Primers. 2015;1:15025.
  7. Gupta RS, Warren CM, Smith BM, et al. Prevalence and Severity of Food Allergies Among US Adults. JAMA Netw Open. 2019;2(1):e185630. doi:10.1001/jamanetworkopen.2018.5630
  8. Asthma and Allergy Foundation of America (AAFA) AD Prevalence study. Accessed January 30, 2024. https://aafa.org/wp-content/uploads/2022/08/Atopic-Dermatitis-in-America-Study-Overview.pdf
  9. Endpoints News. Regeneron has a winner in Dupixent and big sales hopes. Accessed February 6, 2024. https://endpts.com/regeneron-has-a-winner-in-dupixent-and-big-sales-hopes-so-why-are-so-few-patients-taking-it/
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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.

Kari Brown, M.D.

Executive Vice President, Clinical Development, Operations and Strategy

Kari Brown, a board-certified allergist and immunologist, brings 10 years of experience in clinical treatment deployment, development and strategy to Revolo. In her various roles, Kari has played an integral part in advancing pipelines across allergy and immunology disease indications.

Femi Oluboyede

Vice President, Technical Operations, CMC

Femi Oluboyede has over 20 years of experience within the bio-pharma industry, with a proven track record of achieving strategic corporate objectives. Through his roles, Femi has excelled in fostering alignment across functional teams, including Process Development, Tech-transfers, cGMP Manufacturing in Biologics, Small molecules, Proteins and Synthetic Peptides. He has succeeded in delivering investigational products and providing support across different phases of clinical trials.

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