UK-based Leucid Bio has dosed the first subject in the multi-centre Phase I AERIAL trial of autologous lateral chimeric antigen receptor T-cell (CAR-T) cell therapy LEU011, aimed at treating refractory solid tumours.
This trial’s commencement comes after a first close of a Series A1 financing round, raising £7.2m ($9.5m) this February and brought the total Series A funding to £18.7m ($24.8m).
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The dose-escalation study is aimed at assessing the clinical activity and safety of LEU011, testing the therapy’s single intravenous dose after the preconditioning chemotherapy in individuals suffering from refractory solid tumours.
It will be conducted at two locations in the UK, with initial proof-of-concept data anticipated in the second half of this year.
The study aims to determine the maximum tolerated dose (MTD) and evaluate the tolerability and safety of LEU011.
Subjects enrolled in the trial will have their whole blood procured for manufacturing LEU011. They will then be given a single intravenous dose of the therapy post-preconditioning chemotherapy and monitored for up to two years.
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By GlobalDataLeucid Bio CEO Filippo Petti said: “The initiation of the AERIAL trial is a significant milestone for Leucid. LEU011 has demonstrated striking anti-tumour activity preclinically, while illustrating the potential to overcome challenges in treating refractory solid tumours.”
According to the company, LEU011 targets natural killer group 2, member D (NKG2D) stress ligands, which are said to be prevalent in over 80% of human tumour cells and the tumour microenvironment.
To improve tumour infiltration and cell trafficking, LEU011 has been engineered to jointly express the chemokine receptor (CXCR), CXCR2.
This therapy claims to be the first CAR-T candidate for solid tumours to be manufactured at the Zayed Centre for Research at Great Ormond Street Hospital (GOSH).
The company secured access to the good manufacturing practice (GMP) production facilities at GOSH through a March 2023 agreement.
Leucid Bio is focused on cell therapy development for the treatment of solid tumours, leveraging its lateral CAR platform.
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