Zelluna has received positive scientific advice from the MHRA, marking a key step forward in advancing its lead TCR-NK cell therapy candidate, ZI-MA4-1, towards first-in-human clinical trials in the UK.
The MHRA feedback aligns with the preclinical, manufacturing, clinical and regulatory development pathway for ZI-MA4-1, supporting Zelluna’s plan to submit a Clinical Trial Application (CTA) by the end of 2025.
As part of its UK clinical strategy, Zelluna has engaged leading cancer centres and appointed Professor Fiona Thistlethwaite, Medical Oncology Consultant at The Christie NHS Foundation Trust, as proposed Chief Investigator.
The Christie — one of Europe’s foremost cancer centres and a hub for advanced cell therapy research — is expected to serve as the study’s lead site.
Both Professor Fiona Thistlethwaite at The Christie and Dr Andrew Furness at The Royal Marsden in London are expected to play central roles in the trial and have contributed to shaping its design and development strategy.
“Receiving positive scientific advice from the MHRA is an important milestone as we prepare to bring ZI-MA4-1 into the clinic,” said Namir Hassan, CEO of Zelluna.
“With the involvement of world-class investigators and centres such as The Christie and The Royal Marsden, we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026."
"This progress showcases the talent and dedication of our team, and our shared commitment to advancing a novel, scalable and accessible “off the shelf” cell therapy for patients with solid tumours.”
Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4-1 across multiple solid tumours.
Prof. Fiona Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team (ECMT), Clinical Lead for the Advanced Immunotherapy and Cell Therapy (AICT) Team at The Christie and proposed Chief Investigator for the planned trial, said: “I am genuinely excited to see the progress of ZI-MA4-1 into the clinic."
"I am optimistic that the dual killing mechanism of the NK cells and tumour antigen directed TCR will provide us with the step-change that we need in the solid tumour setting to provide the required level of tumour potency whilst avoiding tumour escape."