Leucid Bio and Great Ormond Street Hospital enter commercial agreement at new gene therapy manufacturing centre
- Agreement to manufacture Leucid Lead asset, LEU011 for the treatment of solid tumours and haematological malignancies utilising facilities and quality assurance services at the Zayed Centre for Research into Rare Disease in Children is first-of-its-kind.
- Leucid Bio to retain IP in respect of services arising from this venture.
- Leucid Bio expects to file its CTA to initiate the clinical trial in H1 2023 and subject to regulatory approval to be dosing patients, by H2 2023.
LONDON, March 16, 2023 /PRNewswire/ -- Leucid Bio ("Leucid" or the "Company"), a biotech company pursuing a differentiated approach to develop next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company's proprietary Lateral CAR Platform to improve treatment outcomes and save the lives of patients with refractory cancers, today announces a first-of-its-kind 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. Leucid Bio 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.
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."