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Product Dev Landscape

‘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 long-term remission for many allergic diseases.

We are developing ‘1104 for the treatment of patients with eosinophilic esophagitis (EoE), allergic disease, and food allergy.

Eosinophilic Esophagitis (EoE)

EoE is a progressive disease characterized by difficulty swallowing and gastric reflux. Roughly 180,000 children and adults in the US have EoE,1 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.

A placebo-controlled, first in human, Phase 13 clinical trial investigating ‘1104 in healthy volunteers and patients with mild asthma demonstrated that ‘1104 is safe at clinically relevant doses. A second Phase 1 multiple ascending dose (MAD) study in 18 healthy subjects showed that ‘1104 is safe and tolerable with no serious adverse events (SAEs).

A Phase 2a trial investigating ’1104 in EoE was completed in 1H 2023, achieving the study’s primary endpoint. A Phase 2b trial investigating ’1104 in EoE is anticipated to begin in 1H 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

A Phase 2 allergen sensitivity study to select the optimal indication for ‘1104 in allergic disease is currently ongoing.

‘1104 Publications

May 19, 2023 | 1104

De Alba J, et al. 2023. “IRL201104, a Novel Immunomodulatory Peptide, Prevents Inflammatory Infiltration and Proinflammatory Cytokine Release in a New Model of ARDS Associated to Influenza Infection.” In A21. Infection, Lung Injury, and Sepsis Models to Translation (pp. A1075-A1075). American Thoracic Society

February 27, 2023 | 1104

De Alba J, et al. 2023. “IRL201104, A Novel Immunomodulatory Peptide, Shows A Long Lasting Reduction In Anaphylaxis Symptoms And Allergy Biomarkers In A Murine Model Of Food Allergy.” Journal of Allergy and Clinical Immunology, 151(2), AB228.

May 17, 2022 | 1104

De Alba J, et al. 2022. “IRL201104, a Novel Immunomodulatory Peptide, Shows a Long Lasting, Dose Response and Wide Spectrum Effect Through Different Routes of Administration in a Model of Allergic Inflammation.” In C21. Drilling Down on Inflammatory Mechanisms in Ashtma via Human Cell and Murine Models (pp. A3743-A3743). American Thoracic Society.

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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. Immune Regulation Ltd. Immune Regulation announces positive results from Phase 1 clinical trial of IRL201104. https://revolobio.com/2019/12/10/immune-regulation-announces-positive-results-from-phase-1-clinical-trial-of-irl201104/. Published December 10, 2019. Accessed May 4, 2021.
  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.
 
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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.

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Jeff Myers, m.d., ph.d

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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.

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Dr. Roly Foulkes

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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.

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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.

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Jonathan Rigby, mba

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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.

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