CSL has entered a strategic option and license agreement with Arizona-based Translational Sciences for their enhanced thrombus dissolving drug candidate, TS23.
TS23 is a first-in-class anti-α2-antiplasmin monoclonal antibody. It is being developed to dissolve thrombi that cause serious conditions such as pulmonary embolism (PE) and acute ischemic stroke (AIS).
CSL said the drug candidate is soon to be evaluated in the US-based Phase 2 NAIL-IT study. The study has been designed to evaluate the safety and thrombolytic effect of ascending doses of TS23 in patients with intermediate-risk acute PE.
“We continue to evolve as a leading biotechnology company which is driven by its promise to patients with purposeful diversity in therapeutic areas, scientific platforms and strategic alliances, and today’s announcement is a further example of this,” said CSL’s vice president R&D, haematology therapeutic area, Dr Brahm Goldstein.
“Pulmonary embolism is a condition of large unmet need, and we look forward to monitoring the Phase 2 study of TS23 to see how this promising treatment candidate could potentially help patients,” he said.
Translational Sciences chief scientific officer Guy Reed said, “The safe dissolution of pulmonary emboli may prevent serious, disabling complications and death. We are pleased that CSL recognized the therapeutic potential of TS23, and we look forward to collaborating with them into the future.”
In a Phase 1 study in healthy volunteers TS23 was found to be safe, and demonstrated dose-related inactivation of α2-antiplasmin. Thrombus dissolution was also demonstrated by biomarkers in vivo and by testing ex vivo.
The terms of the agreement were not disclosed.