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ISM-001 is a potential first-in-class antibody that may lead to a new treatment pathway for patients with peripheral arterial disease (PAD)

Company enters strategic collaboration with Pfizer Ignite to accelerate IND-enabling regulatory studies

IsomAb Ltd, a UK-based biotechnology company developing isoform-specific disease modifying antibody treatments for serious and life-threatening diseases, today announced the nomination of a Development Candidate for peripheral arterial disease (PAD). ISM-001 is a potential first-in-class, therapeutic antibody designed to neutralise VEGF-A₁₆₅b, the anti-angiogenic VEGF-A splice isoform which acts as a brake on development of new blood vessels leading to chronic limb threatening ischaemia (CLTI). ISM-001 is being advanced into a program of pre-clinical studies necessary for gaining approval to enter first-in-human clinical trials.

IsomAb has also entered into a strategic collaboration with Pfizer Ignite to support preclinical development and IND-enabling studies for ISM-001. Pfizer Ignite is an end-to-end service for biotech companies with therapeutics in Pfizer’s strategic focus areas that leverages Pfizer’s significant R&D capabilities, scale and expertise to accelerate the development of breakthrough therapies. IsomAb will retain ongoing decision-making autonomy and full rights to the program throughout the collaboration.

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: “Today’s announcement represents an important milestone for IsomAb and we continue to be encouraged by the potential of ISM-001 as a first-in-class treatment for patients with PAD, especially type 2 diabetics with CTLI at high risk of amputation. We appreciate the devastating loss of losing a limb and the impact on the lives of patients who have very limited treatment options. Given Pfizer’s strong commitment, extensive capabilities and deep expertise in developing new therapeutics, we are proud to partner with them to support the development of ISM-001, a transformative treatment for patients with PAD. We look forward to realising the full potential of ISM-001.”

Kathy Fernando, SVP, Global Head of Pfizer Ignite said: “We look forward to collaborating with IsomAb to advance the preclinical and IND-enabling studies for ISM-001. Pfizer has a strong history developing and implementing trials for vascular diseases, and we plan to leverage this expertise to support and advise IsomAb on their journey to translate compelling science into a potential new first-in-class treatment option for patients with peripheral arterial disease.”

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

IsomAb Ltd, a UK-based biotechnology company developing isoform-specific disease modifying antibody treatments for serious and life-threatening diseases, today announced the expansion of its Clinical Advisory Board (CAB); the key role will be to provide expert clinical knowledge and advice on future clinical trials for the company’s lead programme. The CAB consists of renowned international experts in the fields of vascular surgery and management of diabetic patients with vascular complications. Many of the CAB members have collaborated on recent clinical trials in limb ischaemia including the PACE PIII trial.¹

Jackie Turnbull, CEO of IsomAb Ltd, said: “The expansion of our Clinical Advisory Board comes at an exciting time for our Company as we continue to generate preclinical data in support of ISM-001, a high affinity, humanised antibody designed to restore blood flow in diabetic vascular disease. As we advance our program, we have access to an extraordinary group of renowned clinical experts, who will provide key insights and recommendations to help guide the clinical trial program.”

The Clinical Advisory Board consists of the following members:

Prof. Dr. Maarit Venermo – CAB Chair
Professor Venermo is head of the department of vascular surgery at Helsinki University Hospital. Her research concerns registry studies aiming to evaluate the quality of vascular surgical service as well as international variation in practice. Professor Venermo is currently the Secretary General of  the European Society for Vascular Surgery (ESVS) and has been a member, or other role, of eleven national/international committees, councils and boards. She has been named on 276 publications in the field of vascular surgery.

Prof. Dr. med. Sigrid Nikol
Professor Nikol trained in thoracic and cardiovascular surgery early in her career, then became an interventional cardiologist and interventional vascular physician. She is Head of Department of Interventional Angiology, St. Georg Hospital in Hamburg Germany.  She worked in the early nineties with the pioneer of angiogenesis therapy, Jeffrey Isner MD in Boston, USA. She has over 30 years of experience in translational angiogenesis research, which includes preclinical work and active roles in numerous clinical angiogenesis trials, as Principal Investigator as well as being a member of numerous Steering Committees or Advisory Boards.  She has authored more than 231 publications in the cardiovascular field including current guidelines.  She is past-president of the European Society for Vascular Medicine (ESVM), a member of the German Angiology Society, and the International Andreas Gruentzig Society.

Professor Robert Hinchliffe
Professor Hinchliffe is a Clinical Professor of Vascular Surgery at Bristol Medical School, and the Chair for the Research for Patient Benefit Southwest region. He is Honorary Consultant Vascular Surgeon in the Bristol, Bath, Weston Vascular Network and an academic vascular surgeon with an interest in diabetes related complications of the lower limb and peripheral artery disease. His research interest is in clinical trials and the evaluation of innovative technologies in surgery.

Marc P. Bonaca, M.D., MPH
Marc P. Bonaca, MD, MPH is a Cardiologist and Vascular Medicine Specialist who serves as the Executive Director of CPC Clinical Research and CPC Community Health at the University of Colorado. He is the Director of Vascular Research and an Associate Professor of Medicine at the University of Colorado School of Medicine and the inaugural holder of the William R. Hiatt Endowed Chair in Cardiovascular Research. He is a member of the Society of Vascular Medicine, American College of Cardiology (ACC) and American Heart Association (AHA). He currently serves on the ACC PVD Leadership Council and is an associate editor for the Vascular Medicine.

Professor John C. Lantis
Professor Lantis II, MD, is currently the site Chief and Professor of Surgery at Mount Sinai West Hospital, and the Icahn School of Medicine; in mid-town Manhattan where he practices as a senior vascular surgeon. He is the past president of the New York Vascular Surgery Society, a founding member of the American Board of Wound Medicine and Surgery, and the Vascular Study Group of New York.  He is a world leader in limb salvage and lower extremity wound healing and has been a principal investigator on over 70 clinical trials.

Joseph L. Mills, M.D., FACS
Joseph L. Mills, M.D. is a board-certified vascular surgeon in Houston, Texas specializing in diabetic foot amputation prevention and limb salvage. Dr. Mills has authored nearly 300 peer-reviewed journal articles and book chapters, focused on his clinical and research interests in non-invasive diagnosis, vein graft stenosis, intimal hyperplasia and limb-salvage in patients with diabetes mellitus. He has been the principal investigator for over 40 clinical trials, including a number of current investigations.

Professor Michael Edmonds
Professor Edmonds is a Consultant Physician at King’s College Hospital in London with a special responsibility for care of the diabetic foot.  He developed a multi-disciplinary diabetic foot clinic in 1981, one of the first in the world. He won the Karel Bakker award at the 6th International Symposium on the Diabetic Foot in 2011 and more recently in 2013 the DFSG Achievement Award.  He has also won the Edward James Olmos award for the advocacy in amputation prevention at the DF Con 2014 and gave the Arnold Bloom lecture at Diabetes UK in 2015.

Professor Stephen Bain
Professor Bain is the Clinical Director of the Diabetes Research Unit at Swansea University and Medical Director for Research & Development for Swansea Bay University Health Board. He is also the Chair of the National Specialist Advisory Group (NSAG) for Diabetes in Wales and has been Chief Investigator for several multi-centre trials investigating novel therapies for diabetes; these include LEADER, SUSTAIN 6, PIONEER 6 and most recently SOUL.

¹PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial. January 2024; BJS (British Journal of Surgery) 111(2)