June 9, 2021
NEW ORLEANS and LONDON, and WALTHAM, Mass and VILNIUS, Lithuania – June 9 2021 – Revolo Biotherapeutics (“Revolo Bio” 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, announced today that it has entered into a partnership with Northway Biotech, a global end-to-end biopharmaceutical contract development and manufacturing organization (CDMO), to manufacture its binding immuno-regulatory protein, ‘1805.
Under the terms of the agreement, Northway will provide the full scope of its’ services ranging from cell line development to batch production of ‘1805 Active Pharmaceutical Ingredients (API) and drug product, following Current Good Manufacturing Practices (cGMP), with quality assurance and regulatory compliance support.
“Northway is the ideal partner for our manufacturing needs. Their expertise in cell fermentation, protein characterization and global outreach will enable our upcoming phase 2 clinical trials for ‘1805. The close collaboration between the two organizations will provide a seamless progression from our current drug supply and future process and formulation advancements,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Biotherapeutics.
Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board of Northway Biotech, commented, “We are excited to announce our partnership with Revolo Biotherapeutics for the development and manufacturing of ‘1805. Northway Biotech’s global teams in Waltham, US, and Vilnius, Lithuania will closely collaborate with Revolo Biotherapeutics to expedite success in bringing this first-in-class therapy for patients with rheumatoid arthritis and non-infectious uveitis to market quickly and efficiently.”
Rose Rhomberg, Business Development Director of Northway Biotech, added, “Teamwork has been the cornerstone of Revolo Biotherapeutics and Northway Biotech’s partnership with the goal of delivering drug substance and product for toxicology studies and clinical trials. Our partnership will swiftly move the projects forward to benefit patients with inflammatory and autoimmune diseases.”
‘1805 is a first-in-class compound and a modified analogue of the endogenous binding immuno-regulatory protein (BiP), a key player in immune function. ‘1805 is in development to treat rheumatoid arthritis (RA) and non-infectious uveitis. In a phase 2a clinical study, ‘1805 demonstrated marked anti-inflammatory and immunomodulatory effects and disease remission in patients with RA. Revolo Biotherapeutics is advancing ‘1805 into its second phase 2 trial in patients with RA and a phase 2 clinical trial in patients with non-infectious uveitis.
Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, 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 by preventing the chronic pro-inflammatory immune response that results in autoimmune or allergic disease. ‘1805 is a modified analogue of a key protein in immune function and is entering clinical development for moderate-to-severe rheumatoid arthritis and non-infectious uveitis. ‘1104 is a peptide derived from a natural immune-regulatory protein and is entering phase 2 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.
Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and in Waltham, MA, US.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.
Vladas Algirdas Bumelis, Ph.D.
CEO, Executive Chairman of BoD & Advisory Board