Revolo Biotherapeutics Enters into Partnership Agreement with Northway Biotech to Manufacture its Novel Binding Immunoglobulin Protein, ‘1805, to Support Phase 2 Trials in Rheumatoid Arthritis and Uveitis

NEW ORLEANS and LONDONand 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.”

About ‘1805

‘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.

About Revolo Biotherapeutics

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.

About Northway Biotech –https://www.northwaybiotech.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.

Contacts

Revolo Bio Company Contact

Marylyn Rigby, VP Investor Relations & Marketing
mrigby@revolobio.com

Revolo Bio Media Contact

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

Northway Biotech Contact

Vladas Algirdas Bumelis, Ph.D.
CEO, Executive Chairman of BoD & Advisory Board
vladas.bumelis@northwaybiotech.com

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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 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.

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.

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.

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.

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.

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.