IsomAb Announces Strategic Collaboration with Catalent

Master Service Agreement for ISM-001

First work program initiated August 2024

Strategic collaboration encompassing initial process development through to clinical trial supply

NOTTINGHAM, UK - October 28, 2024 - IsomAb Ltd, a UK-based biotechnology company developing isoform-specific disease modifying antibody treatments for serious and life-threatening diseases, today announced it has entered into a strategic collaboration with Catalent, Inc. the leader in enabling the development and supply of better treatments for patients worldwide. The Master Service Agreement (MSA) encompasses development of ISM-001 from cell line development through to finished clinical trial product supply; work will be performed in the USA and the EU. IsomAb will retain ongoing decision-making autonomy and full rights to the program throughout the collaboration.

ISM-001 is a first-in-class therapeutic antibody designed to neutralise the anti-angiogenic VEGF-A splice isoform VEGF-A165b; the first target patient group are those with type 2 diabetes and peripheral artery disease with symptoms of chronic limb-threatening ischemia. ISM-001 has been nominated as the Development Candidate and is being advanced into a program of pre-clinical studies necessary for gaining approval to enter first-in-human clinical trials.

More than 230 million people worldwide are living with PAD; key risk factors for developing the disease are type 2 diabetes, obesity, high blood pressure and high cholesterol levels. CLTI develops in patients due to lack of resources in primary care and of effective treatments, which results in a high risk of amputation; this has been estimated at 25% at one year¹.

Jackie Turnbull, CEO of IsomAb Ltd, said: "We look forward to working with Catalent, a leading CDMO with premier capabilities in biologics development and manufacturing, on the development of ISM-001. This partnership demonstrates our commitment to a robust manufacturing process that will move our therapeutic program into the clinic as quickly as possible. Catalent's expertise at integrating end-to-end services through their OneBio® offering was a significant factor in our decision to partner with Catalent as we plan for future development of ISM-001."

David McErlane, Group President of Biologics said: "Catalent is committed to partnering early in the development process with innovative companies like IsomAb. We are excited to work together to develop ISM-001 and are committed to the development and manufacturing of safe, high-quality biologic therapies to provide breakthrough treatment to patients."

¹ - Eur J Vasc Endovasc Surg (2020) 60, 643 - 644

For further information please contact:

IsomAb Ltd
E:[email protected]

RHA Communications
E:[email protected]

Notes to Editors

ABOUT IsomAb

IsomAb Ltd, founded in 2022, is a UK-based biopharmaceutical company and is a spin-out from the University of Nottingham; early research was conducted at the University of Bristol and research funding has been received from the British Heard Foundation, Wellcome Trust and the Medical Research Council. The Company was founded by Prof. David Bates and Prof. Steve Harper based on ground-breaking research into VEGF-A and its splice isoforms and focusses on the development of isoform specific antibodies for disease modifying treatment of life limiting diseases. ISM-001 is a high affinity, humanised antibody to restore blood flow in peripheral vascular disease. For more information, visit: www.isomab.bio.

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