* On track to file CTA by year end 2025, with plan to dose first patients and
deliver initial data in 2026
* Planned UK trial to be led by Prof. Fiona Thistlethwaite at The Christie NHS
Foundation Trust, a European hub for advanced therapies, with participation
from Dr. Andrew Furness at The Royal Marsden, a world-renowned centre for
oncology and early-phase clinical research
Oslo, Norway, 9 October 2025 - Zelluna (OSE: ZLNA), a company pioneering
allogeneic ("off-the-shelf") T Cell Receptor-based Natural Killer (TCR-NK) cells
for the treatment of cancer, today announced it has received positive feedback
from the United Kingdom's Medicines and Healthcare products Regulatory Agency
(MHRA) following recent scientific advice. This feedback provides alignment on
the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and
supports Zelluna's planned Clinical Trial Application (CTA) submission later
this year.
In parallel, Zelluna has advanced preparations for the first-in-human trial of
ZI-MA4-1 by engaging with leading UK cancer centres and appointing Professor
Fiona Thistlethwaite, Medical Oncology Consultant at The Christie in Manchester,
as proposed Chief Investigator. The Christie, one of Europe's leading cancer
centres and a major hub for advanced cell therapy research, will serve as a lead
site for the study. Both Professor Fiona Thistlethwaite at The Christie and Dr.
Andrew Furness at The Royal Marsden in London, a global leader in oncology and
early-phase cell therapy studies, 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, 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"
About Zelluna Immunotherapy
Zelluna Immunotherapy (OSE: ZLNA) is a biotechnology company pioneering the
development of allogeneic 'off-the-shelf' T Cell Receptor-based Natural Killer
(TCR-NK) cells for the treatment of cancer. The company's platform combines the
innate killing power of NK cells with the precision targeting of TCRs, designed
to address the limitations of current cell therapies, particularly in solid
tumours. Zelluna's proprietary manufacturing process enables scalable, cost-
effective production of TCR-NK cell therapies, with potential for broad patient
accessibility. The company's lead program, ZI-MA4-1, targets the MAGE-A4 tumour
antigen and is expected to enter clinical trials in 2026. Zelluna is
headquartered in Oslo, Norway.
For further information, please contact:
Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com (mailto:namir.hassan@zelluna.com)
Phone: +44 7720 687608
Hans Vassgård Eid, CFO, Zelluna ASA
Email: hans.eid@zelluna.com (mailto:[%20hans.eid@zelluna.com])
Phone: +47 482 48632
For media enquiries, please contact:
Frazer Hall/Mark Swallow - MEDiSTRAVA
Email: zelluna@medistrava.com (mailto:zelluna@medistrava.com)
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Hans Vassgård Eid, CFO of
Zelluna ASA, on 9 October 2025 at 07.57 CET.