4D pharma plc, a pharmaceutical company leading the development of Live Biotherapeutics, has entered into a research collaboration and option to license agreement with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics (“LBPs”) for vaccines.
Founded in 2014, headquartered in Leeds, UK, 4D is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism. 4D’s Live Biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has four clinical studies in progress, namely a Phase II clinical study of Blautix in Irritable Bowel Syndrome, a Phase I/II study of MRx0518 in combination with KEYTRUDA® in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours and a Phase I/II study of MRx-4DP0004 in asthma. Other focus programmes include disease areas such as CNS disease.
Founded in 1891, Merck & Co, the seventh largest biopharmaceutical company by revenue’s vision is to make a difference in the lives of people globally through innovative medicines, vaccines, and animal health products. The company is committed to being the premier, research-intensive biopharmaceutical company and is dedicated to providing leading innovations and solutions for today and the future. The mission is to discover, develop and provide innovative products and services that save and improve lives around the world.
Under the terms of the agreement 4D’s proprietary MicroRx® platform will be paired with MSD’s expertise in the development and commercialisation of novel vaccines, to discover and develop LBPs as vaccines in up to three undisclosed indications. 4D has the right, subject to certain conditions, to cause MSD to purchase $5 million in ordinary shares in 4D during the first 12 months of the collaboration. In addition to an upfront cash payment, for each indication, 4D will be eligible to receive up to $347.5 million in option exercise and development and regulatory milestone payments, plus tiered royalties on annual net sales of any licensed products derived from the collaboration. MSD will be responsible for development, manufacturing and commercialisation following the exercise of any of its exclusive options.
“This research collaboration agreement brings together 4D’s innovation in the microbiome space and MSD’s track record of developing cutting-edge vaccines. MSD and 4D have worked closely combining world leading science to develop a workplan to advance the understanding of this field, with the aim of generating a new class of vaccines in areas of high unmet need.” – Duncan Peyton, Chief Executive Officer, 4D pharma
“A key element of our focus in the Exploratory Science Center is the evaluation of emerging new areas of biology that have the potential to offer major beneficial impact to human health. By applying 4D’s MicroRx® technology we hope to gain meaningful insights into the role for the host microbiome in modulating the immune response and ultimately protection conferred by vaccines.” – Daria Hazuda, Chief Scientific Officer, Exploratory Science Center, and Vice President of Infectious Diseases and Vaccines Discovery Research, MSD