Celleron Therapeutics, the UK-based company and Oxford University spin-out developing personalised medicine for cancer patients, has today announced the initiation and first patient enrolment of its clinical study that will evaluate the effect of a novel combination therapy approach for colorectal cancer.
Professor Mark Middleton, Consultant Medical Oncologist and Professor of Experimental Cancer Medicine at the University of Oxford commented: “We are delighted to be part of this important trial, which has the potential to bring immunotherapy to patients who hitherto have not benefitted from this approach. It is also very satisfying to see CXD101, a drug first given to patients at the Experimental Cancer Medicine Centre here in Oxford, developed further in the clinic based upon scientific insights made here in the city.”
The Medicines and Healthcare products Regulatory Agency (MHRA) granted Celleron Therapeutics Clinical Trial Authorisation to conduct a Phase Ib/II clinical trial with CXD101, a highly potent class 1 histone deacetylase inhibitor, in combination with an immune oncology (IO) agent, nivolumab. Celleron appointed Syneos Health as the CRO to support the trial which is investigating the clinical activity of CXD101 in combination with nivolumab, measuring the anti-tumour effect on a type of colorectal cancer (microsatellite stable) which typically does not respond to IO agents alone. The clinical trial strategy rests on compelling pre-clinical results which provide novel insights into how CXD101 and IO drugs work together to re-engage recognition of tumours by the immune system. The trial will also allow exploration of a range of new biomarkers to help select those patients likely to benefit most from combination therapy.
Professor Nick La Thangue, Founder and Chief Executive of Celleron Therapeutics, and Professor of Cancer Biology in the Department of Oncology at Oxford University, commented: “CXD101 is a very interesting drug with great clinical potential. The new trial is a major step forward in understanding its therapeutic application. We have observed striking effects on late stage cancer patients in previous studies. This trial exploits our deep scientific understanding of how CXD101 exerts anti-cancer activity, which underpins the hypothesis being tested in the novel combination approach.”
CXD101 is Celleron Therapeutics’ next generation epigenetic immune-regulator representing a class of drug that kills cancer cells by blocking certain vital functions involved in gene expression and reactivates the patient’s immune system so that cancer cells can no longer evade immune recognition.
Professor David Kerr CBE, Founder and Chief Medical Officer, Celleron Therapeutics and Professor of Cancer Medicine, University of Oxford commented: “There is a very significant unmet need for novel therapy for patients with advanced colorectal cancer. As colorectal tumours progress, they find a variety of ways to avoid recognition and destruction by the immune system, increasing their potential to grow and spread. We have discovered that CXD101 can reverse this process of “immune silencing” making it, potentially, an ideal partner for existing immune oncology agents.”
Content adapted from Celleron Therapeutics website.