Cancer Research UK’s Drug Development Office; Cancer Research Technology, the charity’s commercial arm; and biopharmaceutical company, Lorus Therapeutics Inc. (Lorus) (TSX:LOR), have partnered to take a new therapy with the potential to treat solid tumours, into its first clinical trial.
The treatment, IL-17E, is a type of protein called a pro-inflammatory cytokine which, according to research done at Lorus, is thought to elicit an immune response which attacks cancer cells, and determining exactly how it does this will form part of the work being done.
It incorporates technology owned by both Lorus and Genentech. Lorus scientists were the first to discover the anticancer properties of IL-17E against a range of solid tumours.
Cancer Research UK’s Clinical Development Partnerships (CDP) is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anticancer agents that may not otherwise be developed, and take them through preclinical development and early clinical trials.
With the CDP scheme, companies retain the background rights to their programmes while enabling Cancer Research UK to take on early development work to evaluate the benefit to cancer patients. Three drugs are now in clinical trialswith others scheduled to open early 2013.
Cancer Research UK’s DDO will fund and undertake extensive preclinical work led by Professor Christian Ottensmeier at the University of Southampton, England, to further investigate the mechanism by which the protein destroys cancer cells and to further develop the drug for use in treating cancer patients.
The DDO will then fund, manage and sponsor the first Phase I clinical trial led by Professor Chris Twelves and Dr Christy Ralph at the Cancer Research UK/NIHR Leeds Experimental Cancer Medicine Centre, based at the University of Leeds, England. Lorus will manufacture and supply IL-17E for the non-clinical toxicology and Phase I clinical studies.
Professor Christian Ottensmeier, Cancer Research UK scientist at the University of Southampton, said: “This important partnership means we’ll be able to better understand how this molecule destroys cancer cells. We will investigate if it somehow supercharges the immune system to hunt down and attack cancer cells, or if it is able to trigger a ‘suicide’ signal in these cells so they self-destruct, or both, as suggested by research already done at Lorus.
“This will give us the evidence we need to take this drug further into clinical trials to investigate potential benefit to patients.”
After the Phase I trial, Lorus will have the exclusive option to license the Phase I clinical trial data and resume further clinical development. If it does not exercise this option, the rights to the programme would be transferred to Cancer Research Technology to secure an alternative partner, with the aim to make the treatment available for cancer patients while Lorus would retain certain economic interests.
Dr Aiping Young, President and CEO of Lorus, said: “At Lorus our primary focus is to discover and develop novel therapies to treat some of the most important and hard-to-treat cancers. IL-17E fits all the criteria to potentially qualify as a truly unique, first-in-class cytokine-based approach to treating a range of solid tumours.
“Cancer Research UK is world renowned for its cancer research and has done similar partnership deals through its CDP initiative with some of the world’s largest pharmaceutical companies. We believe this partnership with Cancer Research UK is not only a validation of our IL-17E technology, but it also offers Lorus an innovative avenue to develop this programme, and affords us the opportunity to progress as many of our programmes as possible into the clinic.
“We are excited about collaborating with Cancer Research UK and its important network of academic and clinical collaborators in the immunotherapy field and look forward to the outcome of some key studies in the next 24 months.”
Dr Victoria John, head of clinical partnerships, at Cancer Research UK’s Drug Development Office, said: “Without our unique CDP initiative, it might not have been possible to develop this promising treatment, stalling progress to provide potential new options for patients for whom existing treatments no longer work.
“We’re delighted to be working with our Canadian partner Lorus Therapeutics right from the start – collaborating closely in the preclinical research right through to manufacture and the first ever trial with patients.
“IL-17E is the third biological treatment we have brought into the CDP portfolio, building on our existing partnerships with international pharmaceutical and biotechnology companies to develop a multipeptide vaccine, a monoclonal antibody as well as five other molecularly targeted drugs.
“This latest partnership further demonstrates the breadth of molecules we can develop. And we will continue to seek future partnerships, so that by working alongside industry to combine skills and expertise we can reach our goal to license new treatments, and save more lives from cancer.”
IL-17E was selected following a rigorous peer-review process conducted by Cancer Research UK’s New Agents Committee (NAC). Assessment of IL-17E by the NAC was based on several criteria, including scientific rationale, quality of the anticancer data in relevant tumour models, novelty, and clinical need. IL-17E is the eighth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.
- Genentech has patent rights over the composition of matter to IL-17E and Lorus has patent rights for the use of IL-17E in cancer. Lorus also has an IP licence agreement with Genentech to develop IL-17E for cancer treatment.