ASLAN Pharmaceuticals and Thermo Fisher Scientific Partner to Make High-Concentration Eblasakimab for Future Studies

Thermo Fisher Scientific provides Biopharmaceutical manufacturing expertise and scale-up capacity for Phase 3 clinical trials of eblasakimab.

FREMONT, CA: “Establishing this partnership with Thermo Fisher, a global leader in biologics manufacturing, is an important strategic milestone as we continue to advance the development of eblasakimab towards global Phase 3 clinical trials. Thermo Fisher has made deep investments in biologics development and offers 20 years of process development experience in over 240 biologics development programs, as well as a global infrastructure to scale up biologics manufacturing and deliver production continuity," says Kiran Asarpota, Chief Operating Officer, ASLAN Pharmaceuticals. ASLAN Pharmaceuticals, a clinical-stage, an immunology-focused biopharmaceutical company developing innovative treatments to improve patients' lives, and Thermo Fisher Scientific, the world's leading provider of scientific instruments and services, have partnered to manufacture a high-concentration formulation of eblasakimab for Phase 3 clinical trials. Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor with the potential to provide a distinct efficacy and safety profile for the treatment of moderate-to-severe atopic dermatitis (AD).

“We are confident we have identified the best partner to deliver high-quality drug substance with our new formulation, a critical activity we have been planning for to be Phase 3 ready soon after the readout from the TREK-AD study, with no impact on our previously reported cash runway,” adds Asarpota.

ASLAN has developed a high-concentration formulation of eblasakimab, which allows up to 400mg to be delivered in a single subcutaneous injection and is compatible with various devices. In January 2023, Thermo Fisher aims to manufacture the new formulation in its Good Manufacturing Practices (GMP)-certified commercial-scale manufacturing facilities.

“This partnership with ASLAN is an example of how our world-class development and manufacturing expertise can be used to deliver innovative formulations at scale,” says Leon Wyszkowski, Thermo Fishers President of Pharma Services Commercial Operations. “Our technology, including the 5,000-L Single-Use Bioreactor (SUB), will be used to manufacture the new high-concentration formulation of eblasakimab and will enable larger-scale, single-use capabilities for late-stage trials and commercialization of this potential treatment for AD patients.”

ASLAN is undertaking the randomized, double-blind, placebo-controlled, dose-ranging Phase 2b clinical trial TREK-AD to examine the efficacy and safety of eblasakimab in moderate-to-severe AD patients. This trial's preliminary results are anticipated in the second quarter of 2023. Additionally, the business is conducting the TREK-DX study to examine eblasakimab in moderate-to-severe AD patients previously treated with dupilumab. Initial findings from the TREK-DX investigation are anticipated in the first quarter of 2024.