KangaBio Announces FDA IND Clearance for KGX105, AACR Acceptance of KGX101 Clinical Data Abstract, and Completion of Over $15 Million in Pre-A+ Financing
Time：2026-3-3

KangaBio today announced the achievement of three significant corporate milestones. The company has received FDA clearance for its Investigational New Drug (IND) application for KGX105. Furthermore, an abstract detailing clinical data for KGX101 has been accepted for presentation at the AACR Annual Meeting. To support these advancing programs, KangaBio has successfully raised over $15 million in an oversubscribed Pre-A+ financing round.

KangaBio's Investigational Drug KGX105 Receives FDA "Study May Proceed" Letter to Initiate Phase 1 Clinical Trial

KangaBio announced that its independently developed innovative EGFR×CD3 bispecific T cell engager (TCE) prodrug, KGX105, received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) on February 25, 2026 (IND Number: 179701).

This study (Protocol Number: KGX105ST101) is a first-in-human, open-label, multi-center Phase 1 clinical trial. It will evaluate KGX105 as a monotherapy to assess its safety, tolerability, pharmacokinetic and pharmacodynamic profiles, and preliminary efficacy in patients with locally advanced or metastatic solid tumors, aiming to provide a novel treatment option for patients with limited therapeutic choices.

The treatment of solid tumors has long faced challenges such as resistance to targeted therapies and limited response rates to immunotherapies. In particular, patients with EGFR-positive tumors have extremely limited options after failing standard therapies. As a core pipeline asset, KGX105 incorporates an innovative prodrug design and tumor-specific activation mechanism. It is expected to retain potent antitumor activity while addressing the off-target toxicity issues associated with traditional TCE drugs, striving to deliver safer and more effective treatment options to cancer patients worldwide.

KangaBio's KGX101 Phase 1 Clinical Data Abstract Accepted for the 2026 AACR Annual Meeting

The Phase 1 clinical data abstract of KangaBio's lead pipeline candidate, KGX101, has been accepted for poster presentation at the 2026 American Association for Cancer Research (AACR) Annual Meeting. As one of the most influential academic gatherings in the global oncology research community, the AACR Annual Meeting highlights cutting-edge advancements in basic cancer research and clinical translation. At this event, KangaBio will publicly share the safety and efficacy data from the KGX101 Phase 1 clinical trial for the first time. The abstract is titled: "First-in-Human Study of the IL-12 Prodrug KGX101 Demonstrates Tumor-Microenvironment Specific Activation, Promising Antitumor Activity, and a Manageable Safety Profile in Advanced or Metastatic Melanoma."

KangaBio Completes Over $15 Million Pre-A+ Financing Round to Accelerate Global R&D Progress

In the fourth quarter of 2025, KangaBio completed a Pre-A+ financing round exceeding $15 million. The round was led by a leading global biotechnology company, with participation from Bohe Angel Fund,Qianju Enterprise Management Partnership (Limited Partnership), and Hangzhou Taikun Equity Investment Fund Partnership (Limited Partnership) as a follow-on investor. The funds will be primarily used to accelerate the clinical development of the company's globally innovative prodrug candidates and to expand its subsequent pipeline.

Dr. Weidong Jiang, Chief Executive Officer of KangaBio, commented: "The FDA's clearance of KGX105, our second pipeline candidate, for clinical trials marks a pivotal moment in the company’s growth and reflects the increasing maturity of our prodrug platform technology. We look forward to thoroughly evaluating the safety and preliminary efficacy of KGX105 in this Phase 1 study, which will lay a solid foundation for its continued clinical development. The encouraging early clinical results from KGX101 have further validated our prodrug platform, offering valuable insights and confidence as we advance our pipeline. We extend our sincere gratitude to both existing and new investors for their continued trust and support. We are committed to accelerating the progress of our clinical programs and bringing new treatment hope to cancer patients around the world."

About KangaBio

Founded by Dr. Weidong Jiang, KangaBio brings together a core team of scientists, clinical experts, and senior industry managers with extensive experience in biopharmaceutical research and development. Driven by the mission to address unmet medical needs in oncology, the company is dedicated to advancing innovative prodrug molecules of immune agonists and multispecific antibodies. By leveraging precision-targeted design and breakthrough technology platforms, KangaBio aims to reduce drug toxicity, enhance therapeutic efficacy, and deliver high-quality treatment options to cancer patients around the world.