Leucid Bio, a privately-held biotechnology company developing innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies, announced today that the first patient has been dosed in its Phase 1 AERIAL trial. The study is evaluating the safety and clinical activity of LEU011, the company's lead candidate for patients with refractory solid tumors.
The trial initiation follows the successful first close of Leucid's Series A1 financing round of £7.2 million in February 2025, co-led by Epidarex Capital and 2invest AG. This brings the company's total Series A funding to £18.7 million to date, providing crucial support for advancing its proprietary lateral CAR platform technology.
Novel Approach to Solid Tumor Challenges
LEU011 represents a significant advancement in CAR-T therapy for solid tumors, which have historically proven resistant to CAR-T approaches that have been successful in hematological malignancies. The therapy targets NKG2D stress ligands, which are overexpressed on more than 80% of human tumor cells and the surrounding tumor microenvironment.
What distinguishes LEU011 is its engineered co-expression of the chemokine receptor CXCR2, designed to enhance cell trafficking and tumor infiltration. This additional mechanism directly addresses one of the major limitations of current CAR-T therapies in development for solid tumors – poor infiltration into the tumor tissue.
Filippo Petti, Chief Executive Officer of Leucid Bio, emphasized the significance of this milestone: "The initiation of the AERIAL trial is a significant milestone for Leucid. LEU011 has demonstrated striking anti-tumor activity preclinically, while illustrating the potential to overcome challenges in treating refractory solid tumors."
Manufacturing Partnership with Great Ormond Street Hospital
LEU011 marks another important first as the inaugural CAR-T candidate for solid tumors to be manufactured at the Zayed Centre for Research at Great Ormond Street Hospital (GOSH). Leucid gained access to these state-of-the-art Good Manufacturing Practice (GMP) production facilities through an agreement announced in March 2023.
Stephen Mathew, Head of Innovation at the Great Ormond Street Hospital Cell and Gene Therapy Service, commented on the partnership: "We're proud to have supported the manufacturing of LEU011 through our partnership with Leucid Bio, using our specialized 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."
AERIAL Trial Design and Timeline
AERIAL is designed as a multi-center, dose-escalation trial investigating a single intravenous dose of LEU011 following preconditioning chemotherapy in patients with refractory solid tumors. The study continues to enroll patients, with initial proof-of-concept data expected in the second half of 2025.
The trial is registered on ClinicalTrials.gov under the identifier NCT06193902, where additional information about the study design, eligibility criteria, and participating centers can be found.
The Lateral CAR Platform Technology
Leucid Bio's proprietary lateral CAR platform represents a novel approach to CAR-T design. Traditional CAR-T cells have shown limited efficacy against solid tumors due to several factors, including poor tumor infiltration and the immunosuppressive tumor microenvironment.
The lateral CAR design aims to more closely mimic natural T-cell receptor signaling, potentially leading to improved efficacy and reduced toxicity. When combined with the CXCR2 co-expression in LEU011, this approach offers a multi-faceted strategy to overcome the barriers that have limited CAR-T therapy in solid tumors.
Implications for Solid Tumor Treatment
Solid tumors represent approximately 90% of adult human cancers, yet CAR-T therapy success has been largely limited to blood cancers. If LEU011 demonstrates clinical efficacy in the AERIAL trial, it could represent a significant breakthrough in extending the benefits of cellular immunotherapy to a much broader patient population.
The targeting of NKG2D ligands is particularly promising due to their widespread expression across multiple tumor types, suggesting potential applications across various solid malignancies. Additionally, these stress ligands are often upregulated in response to chemotherapy and radiation, potentially making LEU011 complementary to existing treatment modalities.
As enrollment continues in the AERIAL trial, the oncology community will be watching closely for the initial data expected in late 2025, which could provide important insights into the potential of this novel approach to address the significant unmet need in solid tumor treatment.
