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The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.
On Sept. 9, 2019 Lonza and the Netherlands-based biotech firm Citryll announced they have entered into a partnership to develop and manufacture Citryll’s therapeutic anti-citrullinated protein antibody (tACPA), CIT-013. The antibody targets neutrophil extracellular trap (NET) biology and could offer new treatment options for a range of diseases where NETs play a role in disease pathology, including autoimmune diseases such as lupus, rheumatoid arthritis, vasculitis, and others.
Under the partnership, Lonza will carry out cell-line construction as well as cGMP drug substance manufacturing at its Slough, UK, site. Drug product manufacturing for Citryll’s clinical supply needs will be carried out at Lonza’s recently acquired facility in Stein, Switzerland. The two companies will also work together on the regulatory requirements to secure a successful clinical trial application/investigational new drug filing. Citryll aims to start CIT-013 clinical studies in two years.
NETosis is the formation of neutrophil extracellular traps, a recently discovered function of neutrophils, part of the innate immune system. By targeting NET formation and NETs directly, CIT-013 does not broadly target inflammation or acquired immunity, but rather targets the source of autoantigens, proinflammatory as well as toxic NET components, according to the companies. Scientific teams from both companies have been working together to develop this lead antibody candidate. Citryll further improved the quality and the potency of the product using Lonza’s portfolio of in-silico preclinical services to assess manufacturability and immunogenicity.
“With our initial funding secured we’re confident going into the next phase of the development of CIT-013. Having access to Lonza’s expertise in manufacturing and regulatory pathways will help us move to the clinic as efficiently as possible, bringing new therapeutic options to those suffering from illnesses where NETs induce the pathology including autoimmune diseases such as lupus,” said Helmuth van Es, CEO, Citryll, in a company press release.
“Citryll is at an exciting time in their development program and we will be supporting them to help ensure they are fully prepared for a first in-human clinical trial of their new therapy. Early-stage companies are an important part of our business and we have the tools and technologies to help de-risk their candidate. Ensuring solutions for the lifecycle of their product together with business models in sync with their funding all contribute to reducing the risks for growing companies,” added Karen Fallen, head of mammalian and microbial development and manufacturing, Lonza, in the press release.