Abzena and Lipum AB Sign Integrated CMC Agreement to Produce a Novel Biologic for Autoimmune Inflammatory Diseases
Abzena, the global biologics gene to GMP partner research organization, announced it has signed an agreement to support an integrated CMC program with Lipum, a company developing treatments for chronic inflammatory diseases.
Abzena will support Lipum’s anti-BSSL antibody IND program to help develop a novel therapeutic option for autoimmune inflammatory diseases, including juvenile idiopathic arthritis. The 18-month program includes: development of a research cell bank using Abzena’s proprietary cell line and ambr® 15 automated high throughput bioreactors, generation of master cell banks, scale up using an ambr® 250 during process development, followed by cGMP manufacturing in Sartorius 500 L single use stirred tank bioreactors for clinical material. The work will take place at Abzena’s sites in Cambridge, UK and San Diego, USA.
Jonathan Goldman, CEO of Abzena, said:
“Autoimmune inflammatory diseases such as juvenile idiopathic arthritis represent significant unmet medical need. We are delighted to leverage our expertise and integrated capabilities to accelerate the timeline to first in man evaluation. Lipum is an innovative science driven organization with visionary leadership and I am personally very excited about the potential for anti-BSSL therapeutics to transform patient outcomes.”
Einar Pontén, CEO of Lipum, said:
“A lead drug candidate has been selected, so this is an exciting step in Lipum's development. Our antibody is directed towards a novel target protein and will meet a significant medical need. It is essential to have such a competent partner as Abzena. We have a very positive impression of both their resources and staff. It will be stimulating to work with them.”
BSSL (bile salt-stimulated lipase) is a novel target for treatment of autoimmune inflammatory diseases which acts by promoting recruitment of inflammatory and immune cells to the site of acute inflammation, which in the normal case helps to control the inflammation. However, when an inflammation becomes “chronic” the effect of BSSL instead contributes to sustaining the inflammation. The anti-BSSL antibody being developed aims to inhibit this inflammatory process. The efficacy has been demonstrated in several different animal inflammation models. Lipum is evaluating the possibility to address Juvenile Idiopathic Arthritis (JIA) as the first indication for the product.
Lipum has received funding from the European Commission, Executive Agency for Small and Medium-Sized Enterprises (EASME), under the EU Framework Programme for Research and Technological Development (Horizon 2020) for the purpose of developing its BSSL antibody for treatment of various autoimmune diseases.
Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and ADC drug development services in the pharmaceutical industry. The company maintains resources around the world, with facilities in the US and UK. Abzena is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors. For more information, please see www.abzena.com .
Lipum is a Swedish company aiming for better quality of life for the millions suffering from chronic inflammatory diseases, including children. They intend to increase their quality of life and decrease the considerable health care and societal costs. Lipum is currently developing an alternative to current biological treatments for patients not responding, or responding transiently to current TNFα inhibitors. For more information, visit www.lipum.se .
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