First participant dosed in clinical trial of new rectal cancer investigational drug at UCLH

UCLH recruited the first participant in Europe to the FORTRESS study, a study of a novel treatment for locally advanced rectal cancer (LARC).

The participant received their first dose of the study medication NG-350A, a type of therapy called an oncolytic immunotherapy, at the NIHR UCLH Clinical Research Facility  in October.  The researcher leading the study at UCLH is Professor Maria Hawkins, Professor of Radiotherapy at UCL and consultant radiotherapist at UCLH.

The FORTRESS study is testing the safety and efficacy of NG-350A, the first oncolytic immunotherapy of its type to be administered at UCLH, given in advance of chemotherapy and radiotherapy (known as chemoradiotherapy), the standard initial treatment for locally advanced rectal cancer.

NG-350A, which is administered as an intravenous infusion, is designed to reach and enter solid tumours, carrying an antibody that activates antigen presenting cells, subsequently driving the immune system to attack the cancerous cells, without impacting healthy cells. The aim is to develop a therapy for people with LARC that enables them to potentially avoid surgical interventions that today are standard practice following chemoradiotherapy.

Colorectal cancer is the fourth most prevalent cancer in the UK, of which rectal cancer is a subset. LARC, which occurs in approximately 60% of rectal cancer patients, is defined by the spread of the rectal cancer to nearby tissues or lymph nodes. In patients with LARC, tumours have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs or structures and/or into the lymph nodes.

The clinical study is taking place at centres in the U.S. and UK and will involve approximately 30 patients.

The first participant said: “I would like this new treatment to not only help me, but many other people with cancer.  My father died of rectal cancer, so I want to be a part of helping to find better treatments for people now and in the future.”

Professor Hawkins said: “We are delighted to participate in the early testing of a novel way of targeting cancer and contribute to the development of next generation oncolytic immunotherapies to improve outcome in colorectal malignancies.”

The sponsor of this global study is Akamis Bio.

Image: members of the trial team Benedetta Zeni, Michelle Angelique Reyes and Keenjee Nama.