AB2 Bio, a Swiss clinical-stage biotech company developing therapies for the treatment of severe systemic autoinflammatory diseases, and WuXi Biologics agreed to collaborate to set up and accelerate commercial-scale manufacturing of Tadekinig alfa, AB2 Bio’s recombinant IL-18 binding protein.
AB2 Bio is in the process of transferring manufacturing of Tadekinig alfa for the treatment of primary monogenic emophagocytic Lymphohistiocytosis (HLH) to WuXi Biologics, where commercial scale manufacturing will be conducted. AB2 Bio will prepare the submission of the license application to the FDA and initiate commercialization activities, including scaling-up manufacturing, leveraging WuXi Biologics’ services and capabilities.
The pivotal Phase III trial with Tadekinig alfa is expected to read out in mid-2021, after which the BLA process will be initiated. Monogenic HLH is a rare, life-threatening disease that occurs in infants and young children, characterized by hyperinflammation due to an overactivated immune system. There are currently no drugs specifically approved to treat IL-18 driven monogenic HLH and severe inflammatory conditions, disability and death are common outcomes.
“We’re excited to be AB2 Bio’s valued partner in the commercial-scale manufacturing of Tadekinig alfa,” said Chris Chen, PhD, WuXi Biologics. We are committed to the swift delivery of high-quality products and services to customers and, as a result, making life-saving treatments accessible to patients around the world.”
Beyond primary HLH, Tadekinig alfa has potential to be developed as a pipeline-in-a-product for indications where high IL-18 levels play a key role in disease pathology, including other autoinflammatory orphan conditions, oncology and infectious diseases, such as COVID-19, according to AB2 Bio officials.