AbClon Secures U.S. Patent for "HER2 Affibody-Based Switchable CAR-T" Technology

AbClon, an antibody-based new drug development company, announced on September 17 that it has received a decision of patent registration from the United States Patent and Trademark Office (USPTO) for its "HER2 Affibody-Based Switchable CAR-T Technology." With this, AbClon has secured exclusive rights to the technology not only in Korea, Canada, China, Japan, and Australia, but now also in the United States, the world's largest pharmaceutical market. Final registration is also pending in Europe.

The patented technology is a "switchable CAR-T" designed to activate immune cells targeting HER2-expressing cancer cells only when needed. It is a next-generation platform that addresses the fundamental limitations of existing CAR-T therapies.

Currently, all seven CAR-T products approved by the U.S. Food and Drug Administration (FDA) are limited to hematologic cancers. The receptors that recognize cancer cells are permanently attached to T cells, so once administered, the T cells remain in an "always-on" state of continuous activation.

This can result in serious side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and may even lead to attacks on normal cells. Additionally, since these therapies can only target a single antigen, if cancer cells acquire resistance, the effectiveness of the treatment is diminished.

AbClon's switchable CAR-T platform, "zCAR-T," is designed so that CAR-T cells require an intermediary "switch molecule" to recognize cancer cells, rather than recognizing them directly. Like an electric switch, CAR-T cells can be turned on or off only when needed.

AbClon has developed the HER2 affibody-based switchable CAR-T technology using zCAR-T. This technology has been applied as a core component of "AT501," AbClon's first zCAR-T candidate, which is currently in preclinical development as a treatment for ovarian cancer.

An AbClon representative stated, "The U.S. patent registration of our HER2 affibody-based switchable CAR-T technology will serve as a major milestone in pioneering the untapped solid tumor CAR-T market. Having confirmed the potential for the switchable CAR-T platform 'zCAR-T' to expand beyond a single therapy to a platform-based business model, we will accelerate licensing agreements and collaborative development with multinational pharmaceutical companies."