SymBio holds approval for TREAKISYM injectables which are already used for the treatment of three indications of malignant lymphoma (first-line and relapsed/refractory low-grade B-cell non-Hodgkin's lymphoma and mantle cell lymphoma, and chronic lymphocytic leukemia).
The purpose of the Phase 1 study is to evaluate the recommended dose, dosage regimen, the tolerability and the safety of oral TREAKISYM, as it is a new formulation, and to identify types of solid tumors that show promise for treatment.
Based on the efficacy and safety data related to TREAKISYM injectables that were demonstrated in the treatment of malignant lymphoma, the purpose of this study is also to provide a new treatment option for patients by developing the new oral formulation leveraging superior traits and fewer adverse events, including alopecia, compared with existing chemo therapy.
Furthermore, SymBio will evaluate safer dosage regimes with no adverse effect on efficacy by leveraging the pharmacokinetic traits of the oral formulation, specifically, lowering Cmax and administration in lower doses during the treatment period.
Oral formulation drugs can also be taken at home, eliminating the need for the patient to visit the hospital for intravenous infusion and reducing the treatment burden on the patient.
The development of oral TREAKISYM is part of SymBio’s strategy to develop a “TREAKISYM platform.” For TREAKISYM injectables, the Phase III study for the indication of relapsed/refractory diffuse large B-cell lymphoma is underway.
Although DLBCL accounts for the largest segment of malignant lymphoma in terms of patient numbers, currently only multiple drug therapies are available for r/r DLBCL. In addition, SymBio is deploying a sustainable growth strategy and will maximize the value of TREAKISYM by significantly extending the product life through the development of TREAKISYM liquid formulations (TREAKISYM Ready-to-dilute and TREAKISYM Rapid Infusion).