Cancer Research UK and KisoJi Biotechnology Inc have begun a multi‑centre, first‑in‑human, phase 1/2a open‑label trial evaluating KJ‑103, a naked anti‑TROP2 antibody created using KisoJi’s proprietary technology. The first patient has received treatment at The Clatterbridge Cancer Centre in Liverpool.
TROP2 is a transmembrane glycoprotein involved in signalling pathways linked to cancer cell movement and spread. It is expressed across multiple tumour types and is associated with advanced disease and poorer outcomes.
The study will assess increasing dose levels to determine dose selection for further evaluation and will also investigate preliminary efficacy. KJ‑103 will be tested as monotherapy in several solid tumours and in combination with pembrolizumab for locally advanced, unresectable or metastatic head and neck cancer.
Unlike antibody drug conjugates, KJ‑103 does not contain a cytotoxic payload. It recruits immune cells to kill tumour cells by directing macrophage activation and phagocytosis of TROP2‑expressing cancer cells.
KJ‑103 may offer an alternative option for people with TROP2‑expressing cancers where TROP2 ADCs have proved ineffective or unsuitable. Tumour types expressing TROP2 include colorectal, head and neck, ovarian, breast, bladder and lung cancers.
Dr Lars Erwig, Director of the Centre for Drug Development at Cancer Research UK, said: “Treating the first patient in a first-in-human clinical trial is a key milestone in bringing cutting-edge therapies to people affected by cancer.” “We’re pleased to be working with KisoJi on progressing their promising antibody therapy in the clinic, and we thank the study participants and their families for their involvement.”
Dr David Young, co‑founder and CEO of KisoJi, explained: “We are very excited to offer a different way of treating cancer with KJ-103.” “Our partners at Cancer Research UK are crucial to developing this drug, which is the first of its kind coming out of our technology. Validating KJ-103 in these trials leads not only to new options for these patients, but provide impetus for developing other novel drugs from our suite of technologies.”
Professor Christian Ottensmeier, clinical study lead and Principal Investigator at The Clatterbridge Cancer Centre, said: “A critical hurdle in cancer immunotherapy is to make the immune checks aware of the cancer cells.” “KJ-103 will test if we can instruct the immune cells to do their job and to attack the cancer cells. We are delighted to work with Cancer Research UK and KisoJi to bring this opportunity to our patients.”
Cancer Research UK’s Centre for Drug Development is sponsoring the trial and will manage design, delivery and oversight. KisoJi will supply the antibody and complete the preclinical package, while Cancer Research Horizons will manage the commercial relationship.
