GOSH will collaborate with Leucid at the Zayed Centre for Research into Rare Disease in Children

Leucid Bio – a company concentrating on a differentiated approach to developing next generation Chimeric Antigen Receptor T-cell (CAR-T) therapies – has announced a commercial manufacturing master services partnership with Great Ormond Street Hospital NHS Foundation Trust (GOSH).

The link-up will focus on manufacturing lead asset, LEU011. The therapy is a lateral CAR which targets NKG2D ligands for use across human clinical studies. Leucid Bio expects to file its application to commence the clinical trial this year, with a view to dosing patients suffering from solid tumours and haematological malignancies later in 2023 – subject to regulatory approval.

GOSH runs specialised manufacturing facilities for the development and research of cell and gene therapies. The deal also includes clean-room laboratories, storage and specialist training facilities.

Under the terms of the agreement, GOSH will collaborate with Leucid at the Zayed Centre for Research into Rare Disease in Children, while providing quality assurance services required for the manufacturing of clinical products for the LEU011 candidate study.

Other pre-clinical studies have shown that LEU011 consistently performs better than previous generations of CAR T-cells, enabling better control over T-cell activation, superior anti-tumour activity and a sound toxicity profile.

Stephen Mathew, Head of Innovation at GOSH, explained: “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.”

He added: “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.”

Ian Miscampbell, Interim Executive Chairman of Leucid Bio, added: “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.”