Leucid Bio Announces Treatment of First Patient in AERIAL Trial of NKG2D CAR-T Therapy LEU011 for Solid Tumours

• Initiation of AERIAL trial accelerated by successful first close of Series A1 financing 
• LEU011 is first CAR-T candidate for the treatment of solid tumours to be manufactured at Great Ormond Street Hospital (GOSH)
• Enrolment continues in AERIAL trial with initial data for LEU011 expected in the second half of 2025

LONDON, May 12, 2025 /PRNewswire/ -- Leucid Bio ("Leucid" or "The Company"), a privately-held biotechnology company pursuing the development of innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company's proprietary lateral CAR platform, today announced that the first patient has been dosed in the Phase 1 AERIAL trial evaluating the safety and clinical activity of LEU011 in patients with refractory solid tumours.

Initiation of the AERIAL trial follows the successful first close of the Series A1 financing of £7.2 million in February 2025, co-led by Epidarex Capital and 2invest AG, bringing the Series A to £18.7 million to date.  

AERIAL is a multi-centre, dose-escalation trial designed to investigate a single intravenous dose of LEU011 following preconditioning chemotherapy in patients with refractory solid tumours. Initial proof-of-concept data for LEU011 is expected in the second half of 2025.

LEU011 is an autologous lateral CAR-T cell therapy targeting NKG2D stress ligands, which are overexpressed on more than 80% of human tumour cells and the surrounding tumour microenvironment. LEU011 has been engineered to co-express the chemokine receptor, CXCR2, to enhance cell trafficking and tumour infiltration, thereby adding an extra mechanism to overcome significant limitations of CAR-T therapies currently in development for the treatment of solid tumours.

LEU011 also represents the first CAR-T candidate for the treatment of solid tumours to be manufactured at the Zayed Centre for Research at GOSH. Leucid gained access to the state-of-the-art Good Manufacturing Practice (GMP) production facilities at GOSH through an agreement announced in March 2023.

Filippo Petti, Chief Executive Officer, Leucid Bio, stated, "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. It's been fantastic to work with the team at GOSH to accelerate the development of LEU011 in the pursuit of bringing effective cell therapies to patients in need."

Stephen Mathew, Head of Innovation at the Great Ormond Street Hospital Cell and Gene Therapy Service, added, "We're proud to have supported the manufacturing of LEU011 through our partnership with Leucid Bio, using our specialised facilities and quality assurance. This exciting milestone reflects our mission to accelerate innovation in cell and gene therapies and bring hope for better and potentially curative treatments for rare and complex conditions."

Additional information on the Phase 1 AERIAL trial can be found on ClinicalTrials.gov under the identifier NCT06193902.

About Leucid Bio

Leucid Bio is a privately-held biotechnology company dedicated to the development of cell therapies for the treatment of solid tumours using the Company's proprietary lateral CAR platform. The Company's lead asset, LEU011, is an autologous CAR-T cell therapy targeting NKG2D ligands, which are expressed on more than 80% of human tumours. In addition, LEU011 co-expresses the chemokine receptor CXCR2 which is engineered to enhance cell trafficking and tumour infiltration. For more information, please visit the Leucid Bio website at www.leucid.com.

About Great Ormond Street Hospital for Children NHS Foundation Trust

Great Ormond Street Hospital is one of the world's leading children's hospitals with the broadest range of dedicated, children's healthcare specialists under one roof in the UK. The hospital's pioneering research, innovation and treatment gives hope to children from across the UK and the world with the rarest, most complex and often life-threatening conditions.

GOSH is home to the Zayed Centre for Research into Rare Disease in Children, which brings together pioneering research and world-leading clinical care to drive new tests, treatments and cures for rare and complex diseases from lab bench to bedside. The Cell and Gene Therapy Facility within the Zayed Centre for Research is comprised of seven bespoke laboratories and provides comprehensive facilities for all stages of manufacture.