– Agreement ensures supply to support clinical and commercial operations –
NEW ORLEANS, LA and LONDON UK, April 15, 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 Master Service Agreement with a Contract Development & Manufacturing Organization (CDMO), CordenPharma, for the production of Revolo Bio’s first-in-class peptide and immune system resetting drug product, ‘1104, to support upcoming Phase 2 clinical trials in patients with eosinophilic esophagitis (EoE) and allergic disease. CordenPharma is fully equipped to manufacture peptide Active Pharmaceutical Ingredients (APIs) for the clinical supplies of future studies and to serve as an ongoing commercial supply partner.
“CordenPharma is a world leader in the development, scale-up and manufacturing of chemically synthesized APls, making it an ideal manufacturing partner for ‘1104,” said Jonathan Rigby, Group Chief Executive Officer of Revolo Bio. “With this partnership, we are ready to ramp-up and scale-up manufacturing to support our two upcoming Phase 2 trials, which we plan to initiate before the end of 2021. We look forward to further evaluating ‘1104’s ability to reset the immune system to potentially provide patients with a revolutionary treatment option that achieves long-term disease remission without immune system suppression.”
CordenPharma Chief Executive Officer Dr. Michael Quirmbach commented, “The CordenPharma team is looking forward to growing this ongoing commercial supply partnership with Revolo Bio, starting with the manufacture of peptide APIs for their upcoming clinical trials. We are hopeful these important studies will lead to critical life-saving medications for their patients.”
Under the terms of the agreement, CordenPharma will manufacture ‘1104 following Current Good Manufacturing Practices (cGMP) at its facility in Boulder, Colorado.
CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under four Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.
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 clinical development 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.
Marylyn Rigby, VP Investor Relations & Marketing
Monica Rouco Molina, Ph.D.