First patient receives novel heavy-chain-only antibody treatment in new Phase 1/2a trial

Cancer Research UK and KisoJi Biotechnology Inc. (“KisoJi”) announce that the first patient has received treatment in a multi-centre, first-in-human, Phase 1/2a, open-label, adaptive-design trial. The study is designed to assess the safety of KisoJi’s lead asset, KJ-103, a naked anti-TROP2 antibody, which has been created by KisoJi using its proprietary antibody technology. 

The first patient has received treatment at The Clatterbridge Cancer Centre in Liverpool.  

TROP2 is a transmembrane glycoprotein involved in multiple signalling pathways linked to the movement and spread of cancer cells. It is expressed across a range of cancer types, particularly epithelial cancers. TROP2 expression is associated with advanced disease, tumour metastasis, and poorer patient outcomes. 

The trial will investigate increasing dose levels to determine the dose(s) for further evaluation, and will assess the preliminary efficacy of KJ-103. KJ-103 will be studied both as monotherapy in patients with a variety of solid tumours and also when given alongside standard of care pembrolizumab in participants with locally advanced, unresectable, or metastatic head and neck cancer. 

Unlike antibody drug conjugates (ADCs), KJ-103 does not contain a cytotoxic payload. Instead, it functions by recruiting immune cells to kill tumour cells. It uses TROP2 to direct macrophage activation and phagocytosis of tumour cells expressing the target, leading to tumour cell death. 

KJ-103 may offer an alternative treatment option for people with TROP2-expressing cancers where TROP2 ADCs have proved ineffective or are unsuitable due to their toxicity profile. Tumour types expressing TROP2 include colorectal, head and neck, ovarian, breast, bladder and lung cancers. 

Director of the Centre for Drug Development at Cancer Research UK, Dr Lars Erwig, 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 said:  

“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 (CDD) is the trial sponsor and is responsible for the design, management and delivery of the Phase 1/2a clinical trial of KJ-103 in selected TROP2-expressing solid tumours. KisoJi will supply the antibody for the clinical trial and work with CDD to complete the preclinical package. Cancer Research Horizons, Cancer Research UK’s innovation arm, will manage the commercial relationship. 

ENDS 

Cancer Research Horizons is the innovation engine of Cancer Research UK – the world's largest charitable funder of cancer research. It brings together world-leading minds, bold ideas and the right partners to bridge the gap between academic research and taking drugs to market. It focuses on the tougher, more profound ideas that can lead to true innovation, translating them into effective treatments and diagnostics for cancer patients. 

To date, it has played an instrumental role in forming over 90 start-ups. It has helped bring 14 cancer drugs to market, born out of Cancer Research UK's pioneering research. Through these drugs, it has enabled in excess of 6 million courses of treatment for cancer patients across the world. With access to Cancer Research UK's network of 4,000 exceptional researchers, and £400m of annual research spend, it is a powerful partner in the fight to conquer cancer. 

By uniting its commercial partnerships and therapeutic innovation capabilities, Cancer Research Horizons is uniquely placed to support translational funding, entrepreneurial development, data licensing and collaboration, spin-out creation, and offer a full spectrum of drug discovery and clinical capabilities. Every penny it makes goes back into funding the next bold steps, to help bring forward the day when all cancers are conquered.  

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research, influence and information.   
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.    
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 50 years.    
• Cancer Research UK supports research into the prevention and treatment of cancer through the work of over 4,000 scientists, doctors and nurses.   
• Together with its partners and supporters, Cancer Research UK is working towards a world where people can live longer, better lives, free from the fear of cancer.    

 For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on X and Facebook  

Cancer Research UK has an impressive record of developing novel treatments for cancer. 

The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years. It has completed more than 170 clinical trials designed to explore potential new anti-cancer agents in patients. Six of these new agents have reached the market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. 

www.cruk.org.uk/cdd 

KisoJi is a Canadian biotechnology company that deploys the latest scientific and AI tools to conduct therapeutic antibody discovery in a fundamentally new way. KisoJi has developed a multi-species transgenic mouse to generate highly diverse heavy-chain-only antibodies, as well as a modular multi-specific antibody scaffold with high stability and productivity. Most recently, KisoJi has used advanced AI tools to visualise the universe of all antibodies against a target in order to uncover novel biology and new therapeutic antibody capabilities for its partners and its own pipeline. 

www.kisojibiotech.com 

The Clatterbridge Cancer Centre NHS Foundation Trust is one of the UK’s leading cancer centres, serving a population of 2.4m in Cheshire and Merseyside and surrounding areas, including the Isle of Man and parts of Lancashire.  

We provide highly specialist services, including pioneering chemotherapy, immunotherapy and radiotherapy. Our unique networked model includes three Clatterbridge Cancer Centres (Liverpool, Wirral and Aintree), Clatterbridge clinics in other hospitals, and our multi-award-winning Clatterbridge In The Community service, treating patients at home.  

Our flagship Liverpool hospital opened in June 2020 with state-of-the-art facilities, including 110 individual inpatient rooms, stem cell transplant, radiology, a Teenage & Young Adult Unit, clinical therapies, and a wide range of cancer information and support.  

Website: www.clatterbridgecc.nhs.uk 

KJ-103 is a single domain antibody that binds to a unique epitope on TROP2. It acts via effector cell mechanisms, including the activation of macrophages, to kill tumour cells. KJ-103 has been shown to have significant anti-tumour potency with no evidence of toxicity or resistance across a number of preclinical solid tumor models. KJ-103 was humanised by LifeArc. 

Professor Lars Erwig, Dr David Young and other Cancer Research UK spokespeople are available for interview. For media enquiries, contact Fiona Scott in the Cancer Research UK press office on 020 3469 5129 or, out of hours, on 020 3469 8301.   

A lay summary about this trial is available on Cancer Research UK’s website