Affinity Biopharma announced today that it has recently completed the dosing of first patient in Phase II/III clinical study of QHL-108 in patients with soft tissue sarcoma. This clinical trial adopts a multi-center, randomized, double-blind, positive control design to evaluate the efficacy and safety of QHL-108 versus doxorubicin in patients with advanced soft tissue sarcoma.

QHL-108 Legubicin belongs to Category 1 innovative drugs. The first protocol discussion meeting was held in August 2021, and the second national protocol discussion was successfully convened in September of the same year. No.3 Hospital of Hebei Medical University held the department kick-off meeting on December 2021, and on February 24, 2022, the first patient of this trial was enrolled and completed the dosing. We would like to express our appreciation for all relevant researchers and operation teams for their hard work and persistence.

About QHL-108：

QHL-108 is Affinity Biopharma’s phase II/III drug that activates and releases doxorubicin in the tumor microenvironment. It belongs to Category 1 innovative drug. Doxorubicin a chemotherapy medication used to treat multiple types of cancer with strong anti-tumor effects. But it would also cause toxic and side effects including hair loss, bone marrow suppression and especially cardiotoxicity, which limit its clinical application.

QHL-108 utilizes Affinity Biopharma’s Tumor MicroEnvironment Activated (TMEA) platform to enable doxorubicin to accumulate locally in tumors. QHL-108 is a low-toxicity, high-efficiency, and precision-guided chemo-therapy drug. In the previous phase I trial, QHL-108 has obtained good safety and preliminary efficacy evidence, and demonstrated clinical PoC consistent with our design, where it is not activated in the human blood with very low doxorubicin released, and highly activated in the tumor with high level of released doxorubicin. For efficacy data, evidence shows that efficacy increases with the dose escalation, and QHL-108 has showed therapeutic effect in non-sensitive tumors.