Tadekinig alfa, AB2 Bio‘s investigational therapy for hemophagocytic lymphohistiocytosis (HLH), is one step closer to its U.S. market launch, thanks to a new manufacturing agreement between its developer and WuXi Biologics.
AB2 Bio, a Swiss biotech, reached an agreement with WuXi to support the launch of Tadekinig alfa in the U.S., through the use of the Hong Kong company’s open-access biologics technology platforms, the companies announced.
“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,” Michael Soldan, PhD, CEO of AB2 Bio, said in a press release.
“We’re excited to be AB2 Bio’s valued partner in the commercial-scale manufacturing of Tadekinig alfa,” added Chris Chen, PhD, CEO of WuXi Biologics.
HLH is characterized by uncontrolled inflammation due to a process called cytokine storm, in which cytokines — immune system signaling proteins — are overproduced. In this “storm,” a major pro-inflammatory cytokine called interleukin 18 (IL-18) triggers the production of interferon gamma and consequently starts an immune response.
Currently, there are no therapies specifically approved to treat IL-18-induced HLH.
Tadekinig alfa is a recombinant human IL-18 binding protein (IL-18BP) which acts as an inhibitor of IL-18. This therapy is in late-stage development for the treatment of HLH.
A Phase 3 trial (NCT03113760) to assess the safety and efficacy of Tadekinig in children with HLH and other IL-18 driven autoinflammatory conditions is expected to be finished in mid-2021. The trial is currently enrolling participants in several countries, including the U.S. Those interested may check the contacts and locations here.
After completion of this trial, AB2 Bio will prepare the application process for marketing authorization in the U.S. market, through a Biologics License Application to the U.S. Food and Drug Administration (FDA).
“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 said. “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.”
According to Soldan, “Tadekinig alfa has demonstrated to be an effective and safe treatment, changing the lives of the very young patients” with the rare condition.
Making use of its services and resources, WuXi Biologics will be in charge of starting marketing activities, including increasing production.
“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,” Chen said.
Tadekinig alfa has already obtained orphan drug status from the European Medicines Agency and the FDA, as well as the FDA’s Breakthrough Therapy and Pediatric Rare Disease designations. These designations are intended to expedite the development and review of new medications to get them more quickly to patients.
In addition to primary HLH, Tadekinig alfa also is being tested as a potential therapy for diseases in which high levels of IL-18 play a key role, such as other autoinflammatory diseases, cancers, and infectious diseases such as COVID-19.
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