Cancer Research UK and KisoJi Biotechnology Collaborate to Advance Novel Anti-TROP2 Antibody KJ-103 into Clinical Trials

• Cancer Research UK and KisoJi Biotechnology have partnered to initiate a Phase 1/2a clinical trial for KJ-103, a novel naked anti-TROP2 antibody.
• KJ-103 distinguishes itself from antibody-drug conjugates by leveraging immune cell recruitment to induce tumor cell death, potentially reducing toxicity.
• The trial, sponsored by Cancer Research UK's Centre for Drug Development, will evaluate KJ-103 in patients with TROP2-expressing solid tumors, including colorectal and lung cancers.
• Preclinical studies have demonstrated KJ-103's anti-tumor potency without significant toxicity, suggesting it may offer a new treatment option for TROP2-expressing cancers.

Cancer Research UK and KisoJi Biotechnology Inc. have entered into an agreement to advance KJ-103, a first-in-class naked anti-TROP2 antibody, into a Phase 1/2a clinical trial. The collaboration aims to explore a novel therapeutic approach for TROP2-expressing solid tumors, potentially offering an alternative to antibody-drug conjugates (ADCs).

Trial Design and Objectives

Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and manage the clinical trial, focusing on selected TROP2-expressing solid tumors. KisoJi Biotechnology will supply KJ-103 and collaborate with CDD to finalize the preclinical data package. The trial will assess the safety and efficacy of KJ-103 in patients with cancers such as colorectal, head and neck, ovarian, breast, bladder, and lung cancers.

Mechanism of Action

KJ-103 differentiates itself from TROP2 ADCs through its unique mechanism of action. Unlike ADCs, which rely on cytotoxic payloads, KJ-103 recruits immune cells to directly kill tumor cells. By binding to TROP2 at a distinct location from where current TROP2 ADCs bind, KJ-103 activates macrophages, promoting phagocytosis and tumor cell death. This approach may offer a less toxic alternative for patients with TROP2-expressing cancers.

Potential Clinical Impact

KJ-103 may provide a new treatment option for patients with TROP2-expressing cancers who have not responded to or are unsuitable for TROP2 ADCs due to their toxicity profiles. Preclinical studies have demonstrated significant anti-tumor potency with no evidence of toxicity or resistance across various solid tumor models.

Expert Commentary

Lars Erwig, director of the CDD, stated, “We are excited to collaborate with KisoJi to bring KJ-103 into clinical development. With KJ-103’s unique mechanism of action, which harnesses the body’s immune system without the potential toxicity of a drug conjugate, we hope to offer new treatment options for patients with TROP2-expressing solid tumours.”

David Young, co-founder and CEO of KisoJi, added, “As the first naked antibody to target TROP2 cancers, KJ-103 is the first of a new wave of antibodies to come from our modernised technology platform that leverages AI grounded in biology to create transformative antibody therapeutics.”