AB2 Bio Ltd., a Swiss advanced clinical-stage biotech company developing innovative therapies for the treatment of severe systemic autoinflammatory diseases, and WuXi Biologics, a global company with open-access biologics technology platforms, have entered into a collaboration to set-up and accelerate commercial-scale manufacturing of Tadekinig alfa, AB2 Bio’s novel recombinant IL-18 binding protein.

Per the agreement, AB2 Bio is in the process of transferring manufacturing of Tadekinig alfa to WuXi Biologics, where commercial scale manufacturing will be conducted. AB2 Bio will prepare the submission of the license application to the U.S. Food and Drug Administration (FDA) and initiate commercialization activities, including scaling-up manufacturing, leveraging WuXi Biologics’ unparalleled services and capabilities.

Treating Monogenic HLH

The pivotal Phase 3 trial with Tadekinig alfa in primary, monogenic HLH, is expected to read-out in mid-2021, after which the Biologics License Application (BLA) application 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 are eager to progress Tadekinig alfa to the market, and our manufacturing agreement with WuXi Biologics will accelerate commercial scale production, taking critical steps towards bringing Tadekinig alfa to patients,” commented Michael Soldan, CEO of AB2 Bio. “We are now focused on completing enrolment of the ongoing pivotal trial of Tadekinig alfa in primary HLH patients and expect to announce topline results in mid-2021.”

Soldan continued, “In parallel, we are preparing to file for marketing authorization in the U.S. to bring this product as soon as possible to primary, monogenic HLH patients. Tadekinig alfa has demonstrated to be an effective and safe treatment, changing the lives of the very young patients suffering from this devastating condition.”

Dr. Chris Chen, CEO of WuXi Biologics added, “We’re excited to be AB2 Bio’s valued partner in the commercial-scale manufacturing of Tadekinig alfa. From our perspective, this collaboration is a direct result of our Win-the-Molecule strategy to attract customers based on our cutting-edge technology, best timeline, excellent track record and unparalleled capacity throughout the development cycle.”

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.