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Leucid Bio, 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, have announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorisation (CTA) to commence the Phase 1/2 AERIAL clinical trial evaluating the safety and tolerability of LEU011 for the treatment of adults with relapsed or refractory solid tumours.
In September 2022, LEU011 received the innovative medicine designation, the Innovation Passport, as part of the Innovative Licensing and Access Pathway (ILAP) from the MHRA for the treatment of solid tumours expressing NKG2D ligands. Established in 2021, ILAP is a pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
“The MHRA’s authorisation and the ILAP designation for LEU011 highlight the strong potential of our proprietary lateral CAR T candidate LEU011 for the treatment of solid tumours,” commented Filippo Petti, Chief Executive Officer, Leucid Bio. “The development of LEU011 demonstrates our commitment to pushing the boundaries in cell therapy research and underpins our dedicated focus on pursuing novel, durable therapies for cancer patients with limited treatment options.”
Dr. John Maher, Chief Scientific Officer, Leucid Bio, stated, “The design of the AERIAL trial, which was inspired by our exciting preclinical data for LEU011, is aimed at assessing the broad potential of the innovative cell therapy across several solid tumours expressing NKG2D ligands. We look forward to initiating the AERIAL study over the next few months and providing preliminary first-in-human data for LEU011 in 2024.”
About LEU011 and AERIAL Trial
LEU011 is an autologous, lateral CAR T cell therapy targeting NKG2D ligands. The NKG2D receptor enables immune recognition of one or more of the eight human NKG2D ligands expressed on transformed, infected or damaged cells. LEU011 has the potential for the treatment of multiple cancer indications as NKG2D ligands are reported to be expressed on more than 80% of human tumours.
The Phase 1/2 AERIAL trial will evaluate the safety and clinical activity of LEU011 in patients with relapsed or refractory solid tumours following preconditioning chemotherapy. The Phase 1/2 trial consists of an open-label, single-ascending dose design which will identify the maximum tolerated dose for LEU011. Following the dose-escalation portion of the trial, LEU011 will further be evaluated in a dose expansion open-label segment with enrolment of patients with solid tumours expressing one or more NKG2D ligands.