KangaBio Announces First Patient Dosed in Phase I Clinical Trial of KGX105 in China

August 24, 2026 — KangaBio today announced that the first participant has been dosed in the Phase I clinical trial of KGX105, the Company's proprietary innovative EGFR×CD3 bispecific T-cell engager (TCE) and conditionally activated prodrug. This milestone follows KGX105's IND clearance by the U.S. FDA in February 2026 and approval by China's CDE in June 2026, marking the candidate's formal entry into first-in-human (FIH) clinical evaluation.

Study Design

The KGX105 Phase I trial is a first-in-human, open-label, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of KGX105 as monotherapy in patients with advanced solid tumors who have progressed on or are intolerant to standard therapies and have limited treatment options. Priority tumor types for enrollment include EGFR-overexpressing non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), nasopharyngeal carcinoma (NPC), and pancreatic cancer.

Breaking Through the Toxicity Bottleneck of TCE Therapy in Solid Tumors via Conditionally Activated Prodrug Design
EGFR drives multiple epithelial cancers. Conventional EGFR-targeted therapies are often limited by acquired resistance. Although T-cell engagers can redirect T cells to kill tumors, their application in solid tumors has been constrained by systemic T-cell overactivation and off-target toxicity.

KGX105 is a conditionally activated TCE prodrug. Its innovative masking peptide simultaneously blocks both the EGFR- and CD3-binding domains, keeping the molecule inert in circulation. This design minimizes systemic toxicity and immune activation. Upon reaching the tumor microenvironment (TME), tumor-specific proteases cleave the prodrug, releasing the active molecule to trigger T-cell killing precisely at the tumor site.

Dual IND Approvals in China and the U.S. Accelerate Global Clinical Development
KGX105 is the Company's second asset to receive IND approval in both China and the U.S., following KGX101, a next-generation IL-12 prodrug. Phase I data for KGX101 were presented at the 2026 AACR Annual Meeting, providing early clinical validation of the tumor-activated prodrug platform in melanoma.

Dr. Weidong Jiang, Founder and Chief Executive Officer of KangaBio, commented:

"The first patient dosing of KGX105 in China underscores our R&D capabilities and advances our tumor-specific activation platform. While TCE toxicity has limited its use in solid tumors, our prodrug design offers a path toward a broader therapeutic window. With clinical development now underway in both countries, we remain committed to delivering safer, longer-lasting immunotherapy to patients with advanced solid tumors worldwide."

About KangaBio
KangaBio is an innovative biopharmaceutical company dedicated to developing safer and more effective therapies. The Company focuses on conditionally activated immunotherapies, leveraging its leading prodrug protein platform to build a next-generation pipeline of immune agonists and multispecific antibodies. Its core technology employs TME-precision design to reduce systemic toxicity and enhance anti-tumor efficacy, addressing unmet needs in solid tumor treatment.