* On track to file a Clinical Trial Application (CTA) by year end 2025, with
initial clinical data expected mid-2026
* Important step in developing scalable and accessible 'off-the-shelf' cell
therapy for patients with solid tumours
Oslo, Norway, 12 December, 2025 - Zelluna (OSE: ZLNA), a company pioneering
allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell
therapies for the treatment of cancer, today announced the successful
manufacture and QC (Quality Control) testing of the first GMP (Good
Manufacturing Practice) batch of its lead candidate, ZI-MA4-1. This material is
intended for use in Zelluna's upcoming first-in-human clinical trial, marking a
major milestone in the company's progress toward regulatory submission and
patient dosing.
The GMP batch was successfully produced using Zelluna's proprietary
manufacturing process, which was finalised and locked in April 2025. The process
is designed to deliver high-quality TCR-NK products, with the ability to
generate hundreds of doses from a single manufacturing run, offering both broad
patient access and cost-of-goods advantages.
"Having our first GMP batch in storage and ready for our first clinical trial
fills us with hope and excitement as we move closer to bringing our TCR-NK
therapies to patients," said Emilie Gauthy, Head of CMC at Zelluna. "This
successful GMP run, backed by our robust development data, strengthens our
confidence in delivering safe, potent, and consistent therapies at a scale
capable of meeting patient's needs."
ZI-MA4-1 is the world's first MAGE-A4-targeting TCR-NK therapy, designed to
harness both the innate cancer-killing properties of NK cells and the precision
targeting of affinity-enhanced TCRs. The therapy aims to overcome key challenges
facing current cell therapies in solid tumours, including tumour heterogeneity
and antigen loss, while offering an anticipated favourable safety profile and
broad patient access.
"As we approach CTA submission, this achievement represents the final
operational step on our path to the clinic," said Namir Hassan, CEO of Zelluna.
"Together with our compelling preclinical data showing ZI-MA4-1's potent and
selective activity in solid tumour models, this milestone underscores the
strength of our science, our process, and our team. We believe ZI-MA4-1 is a
highly differentiated therapy with the potential to redefine what is possible
for patients with solid tumours. This is a proud and energising moment for
everyone at Zelluna."
Zelluna remains on track to submit a CTA for ZI-MA4-1 in 2H 2025 with initial
clinical data expected mid-2026.
About Zelluna ASA
Zelluna ASA (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
Phone: +44 7720 687608
For media enquiries, please contact:
Frazer Hall/Mark Swallow - MEDiSTRAVA
Email: 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 Joachim Midttun, Finance
manager of Zelluna ASA, on 12 December 2025 at 12.58 CET.