KangaBio's IL-12 Prodrug KGX101: dosing of the first patient was completed
Time：2023-12-13

KangaBio, an innovative biopharmaceutical company focused on developing conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, has announced the dosing of the first patient in a Phase 1 clinical trial evaluating KGX101, the company’s lead pro-cytokine molecule targeting Interleukin-12 (IL-12). This Phase I clinical trial is a first-in-human, multi-center, open-label study assessing KGX101 in patients with advanced or metastatic solid tumors. Additionally, the trial aims to recruit patients resistant to checkpoint inhibitors or those for whom checkpoint inhibitors are not approved, allowing them to receive treatment with KGX101 in combination with a PD-L1 inhibitor in the future.

“We are pleased to announce the dosing of the first patient in our Phase 1 trial of KGX101, marking the entry of the first prodrug molecule from our protein engineering platform into the clinic. KGX101 is an exemplary product showcasing our team's ability to develop our clinical pipeline and validate our innovative approach of creating conditionally activated cytokines as cancer therapies to enhance outcomes for patients with challenging tumors. Initiating patient dosing in our Phase 1 clinical trial with KGX101, a novel tumor-selective IL-12 therapy, is a significant milestone with the potential to address the limitations associated with recombinant IL-12, including toxicities resulting from off-tumor effects. We are enthusiastic about advancing this candidate through the clinic, aiming to provide a new treatment option for individuals living with cancer,” stated Weidong Jiang, Ph.D., Founder, and Chief Executive Officer of KangaBio.

KGX101, a heterodimeric IL-12 prodrug designed for systemic administration but selectively activated in the tumor microenvironment, sets itself apart from other IL-12 molecules. In the first-in-human trial (KGX101ST101), KGX101 is being investigated both as a monotherapy and in combination with a PD-L1 inhibitor in patients with refractory solid tumors. Preclinical studies have demonstrated KGX101's excellent anti-tumor activity and a favorable pharmacokinetic and tolerability profile. The design of KGX101 aims to induce robust anti-tumor activity by stimulating innate and adaptive antitumor immune responses, including NK cell activation, Th1 differentiation, and amplification of antitumor T effector cell responses. For additional information about the trial, please visit www.clinicaltrials.gov using the Identifier: NCT06074497.