Leucid Bio has announced a commercial manufacturing master services agreement with Great Ormond Street Hospital NHS Foundation Trust (GOSH) to manufacture lead asset, LEU011, a lateral CAR targeting NKG2D ligands, for use in human clinical studies.
The company expects to file its Clinical Trial Application (CTA) to initiate the clinical trial in H1 2023 and to be dosing patients suffering from solid tumours and haematological malignancies, by H2 2023, subject to regulatory approval.
GOSH operates specialised manufacturing facilities for research and development of cell and gene therapies. This includes clean-room laboratories, storage and specialist training facilities. Under the terms of the agreement GOSH will work with Leucid at the state-of-the-art cleanroom facilities at the Zayed Centre for Research into Rare Disease in Children and provide quality assurance services required for manufacture of clinical product for the LEU011 first-in-man study, and potentially, other Leucid clinical programmes.
Each party will retain ownership of background IP and Leucid (subject to contractual obligations) will own all Intellectual Property Rights arising from the Manufacturing Services performed.
There have been incredible strides forward in the treatments that we can offer, however, sadly for many these still don’t work
Ian Miscampbell, Interim Executive Chairman of Leucid Bio, said: “We are extremely pleased to enter this first-of-its-kind agreement with GOSH to manufacture our lead asset, LEU011, for use in human studies. Additionally, we are pleased to have started a process with GOSH to examine the feasibility of applying our approach in the paediatric setting where there remains a great unmet need for new therapies. Working in close collaboration with leading institutes such as GOSH is fundamental to our ability to move quickly into clinical trials, using their state-of-the-art manufacturing facilities based here in London.”
Stephen Mathew, Head of Innovation at GOSH said: “Gene and cell therapies are the cutting-edge in clinical research, holding promise to offer personalised cancer treatment, including for rare forms that affect children and young people. At Great Ormond Street Hospital, we see children with the most rare and complex cancers. There have been incredible strides forward in the treatments that we can offer, however, sadly for many these still don’t work. Gene and cell therapies offer hope for better, and potentially curative treatments which is why we’re excited to support innovation in gene therapies through access to these highly specialist and unique facilities.”
CAR T-cell therapy is revolutionary technology in which immune cells, called T-cells, are reprogrammed so they can recognise and destroy cancer cells. This has proven to be a powerful therapy for refractory blood cancers but to date has lacked efficacy for the treatment of solid cancers.
Leucid Bio has developed two proprietary platforms that build upon Dr Maher’s novel ‘lateral’ CAR-T model which develops CAR-T molecules designed to adopt a more natural configuration within the T-cells. The technology gives properties to the CAR-Ts that enable them to consistently outperform previous generations of CAR-T therapies in pre-clinical studies; enhancing T-cell potency and generating a persistent long-term response with reduced toxicity.
LEU011 is based on a novel lateral CAR structure, in which complementary signalling domains are integrated in parallel across the cell membrane. This formation replicates the natural side-by-side position of these molecules across the cell membrane that is seen in endogenous immune receptors.
Previous pre-clinical studies have shown that LEU011 consistently outperforms previous generations of CAR T-cells in those studies, enabling better control over T-cell activation, superior anti-tumour activity, and a favourable toxicity profile.