KGX101, an Innovative IL-12 Prodrug by Kangabio, Completes First Patient Dosing in China
Time：2024-12-10

Following its clinical launch in Australia, Kangabio proudly announced on November 27, 2024, the successful completion of the first patient dosing in China for the Phase I clinical trial (CTR20244181) of KGX101, a next-generation IL-12 immunoagonist developed by the company. This multicenter, open-label, dose-escalation Phase I trial aims to evaluate the safety and tolerability of KGX101, both as a monotherapy and in combination with a PD-L1 monoclonal antibody, in patients with advanced or metastatic solid tumors. This study was approved by CDE in Oct. 11, 2024.

About IL-12 and Its Clinical Study

To date, no IL-12-based immunotherapy drug has been approved for clinical use, as earlier studies faced challenges such as short half-life and systemic toxicity. The advent of prodrug technology, however, has reignited interest in this challenging yet promising research area.

Prodrug technology links cytokines like IL-12 to inactivating domains (masking peptides) via tumor-specific cleavable linkers. These linkers are designed to remain inactive in systemic circulation, minimizing toxicity, and become selectively activated within the tumor microenvironment, triggering a localized immune response.

About KGX101

KGX101 represents a breakthrough as a heterodimeric IL-12 prodrug, designed for systemic administration with activation limited to the tumor microenvironment. In this trial, KGX101 is being evaluated as a monotherapy and in combination with a PD-L1 inhibitor for patients with advanced or metastatic solid tumors.

Preclinical studies have demonstrated KGX101's robust antitumor activity, favorable pharmacokinetics, and good tolerability. KGX101 exerts its effects by stimulating both innate and adaptive immune responses, including to promote activation of natural killer (NK) cell, CD4, CTL and B cells, and helps covert M2 to M1 cells.

About Kangabio

Kangabio is an innovative biopharmaceutical company dedicated to developing therapies that conditionally activate human immunity for cancer treatment. KGX101 is the company’s first IL-12-based prodrug cytokine product.

Since its founding, Kangabio has been committed to advancing safer and more effective therapeutics. Leveraging cutting-edge prodrug protein molecular technology, the company has developed a new generation of immune agonists and multi-specific antibodies to address the unmet clinical needs of cancer patients. To date, Kangabio has built a robust pipeline comprising multiple prodrug candidates.

Statement from Dr. Weidong Jiang, Founder and CEO of Kangabio

"We are thrilled to announce the first patient dosing in the domestic Phase I clinical trial of KGX101. We believe that the addition of China to the clinical program will further accelerate the development of this groundbreaking therapy. KGX101 reflects the Kangabio team's expertise in creating innovative cancer treatments and demonstrates the viability of cytokine prodrug technology. We are optimistic about its potential to deliver meaningful clinical benefits for cancer patients."

Dr. Jiang added, "The first patient dosing in this trial is a significant milestone. Kangabio remains committed to advancing KGX101’s clinical development, aiming to provide cancer patients with a safer and more effective treatment option as soon as possible."