Wednesday, January 04, 2023
ASLAN Pharmaceuticals, a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, and Thermo Fisher Scientific Inc, the world leader in serving science, today announced a partnership 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 that has the potential to deliver a differentiated efficacy and safety profile for the treatment of moderate-to-severe atopic dermatitis (AD).
ASLAN has developed a high concentration formulation of eblasakimab, allowing up to 400mg eblasakimab to be administered in a single subcutaneous injection and suitable for use with different devices. Thermo Fisher plans to commence manufacturing the new formulation in its commercial-scale Good Manufacturing Practices (GMP) certified manufacturing facilities in January 2023.
“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,” said Kiran Asarpota, Chief Operating Officer, ASLAN Pharmaceuticals. “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.”
“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,” said Leon Wyszkowski, Thermo Fisher’s 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 conducting the TREK-AD trial, a global randomized, double-blind, placebo-controlled, dose-ranging, Phase 2b clinical trial, to evaluate the efficacy and safety of eblasakimab in adult patients with moderate-to-severe AD. Topline data from this trial is expected in the second quarter of 2023. The company is also conducting the TREK-DX study to evaluate eblasakimab in adult patients with moderate-to-severe AD who have previously been treated with dupilumab. Topline data from the TREK-DX study is expected in the first quarter of 2024.