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Zelluna doses first solid tumour patient with ZI-MA4-1 in the ZIMA-101 Phase 1 trial

2026-07-13T15:08:17Z
  • First patient dosed with ZI-MA4-1 in the ZIMA-101 Phase 1 trial at The Christie NHS Foundation Trust
  • ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy in clinical development
  • ZIMA-101 represents the first clinical evaluation of Zelluna's proprietary TCR-NK platform
  • Patient identification, pre-screening and screening activities continue across all four tumour indications included in the study
  • Company on track for initial clinical data to emerge from mid-2026

July 13 2026 – Zelluna ASA (OSE: ZLNA), a company pioneering allogeneic “off-the-shelf” T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, today announced that the first patient has been given the first dose in ZIMA-101, the Company’s first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, the largest single site cancer centre in Europe and the lead clinical site for the study where Professor Fiona Thistlethwaite serves as Chief Investigator for the study.

ZIMA-101 is evaluating ZI-MA4-1, the world's first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development, in patients with advanced MAGE-A4-positive solid tumours. MAGE-A4 is present in several common cancer types, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, making it an attractive target for precision cell therapy.

ZIMA-101 also represents the first clinical evaluation of Zelluna's proprietary TCR-NK platform and builds on years of scientific innovation, preclinical research and manufacturing development. The study is now active at two clinical sites in the United Kingdom: The Christie and The Royal Marsden NHS Foundation Trusts.

"This is a defining milestone for Zelluna and marks the beginning of the clinical evaluation of our proprietary TCR-NK platform," said Namir Hassan, Chief Executive Officer of Zelluna. "Dosing the first patient in ZIMA-101 is the culmination of years of scientific innovation, preclinical research and manufacturing development, and represents the transition from laboratory science to treating patients for the first time with our novel TCR-NK therapy. We are deeply grateful to the investigators and the clinical teams for making this milestone possible. We now look forward to advancing the study, generating the first clinical data from our proprietary TCR-NK platform and, ultimately, improving outcomes for patients with advanced solid tumours.”

Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie and honorary professor at The University of Manchester and Chief Investigator for the study said: “Dosing the first patient represents an exciting moment for everyone who has worked collaboratively to bring this brand-new class of cellular therapy to the clinic. In the coming weeks and months, we will be monitoring the patient's progress closely and gathering important data from this very innovative first-in-human early-phase trial, which will inform the next stages of patient recruitment. We are extremely grateful to the patient for agreeing to participate in this important research."

Patient identification, pre-screening and screening activities continue across all four tumour indications included in the ZIMA-101 study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026.

About ZIMA-101

ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom.

The study follows a dose escalation design (3+3) with three predefined dose levels and three patients per dose level. Each patient will receive three doses on Days 1, 4 and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient's data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level.

About ZI-MA4-1

ZI-MA4-1 is Zelluna's lead allogeneic (off the shelf) TCR-NK product candidate and the world's first MAGE-A4-targeting TCR-NK cell therapy in clinical development. The product combines the innate tumour-killing properties of NK cells with precision tumour targeting enabled by affinity engineered T cell receptors (TCRs), with the goal of addressing key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting and access.

For further information, please visit www.zelluna.com or contact:

Namir Hassan, CEO
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Geir Christian Melen, CFO
Email: geir.christian.melen@zelluna.com
Phone: +47 913 02 965

About Zelluna ASA
Zelluna ASA (OSE: ZLNA) is a company pioneering allogeneic 'off-the-shelf' T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of solid cancers. The company's platform combines the innate killing power of NK cells with precise solid tumour targeting of TCRs, designed to address the limitations of current cell therapies in solid tumours. The company's lead candidate, ZI-MA4-1, is the world's first MAGE-A4 targeting TCR-NK therapy in clinical development. Zelluna is headquartered at the Oslo Cancer Cluster Innovation Park in Oslo, Norway and is listed on the Oslo Stock Exchange under the ticker ZLNA.

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 Geir Christian Melen, CFO of Zelluna ASA, on 13 Jul 2026 at 1705 CET.


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