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Zelluna ASA

Regulatory Filings Dec 16, 2025

3779_rns_2025-12-16_469aa3c4-17af-4d36-aa1d-c31dd8bb8849.html

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Zelluna Publishes Compelling Preclinical Data for ZI-MA4-1, the World's First MAGE-A4-Targeting TCR-NK Therapy for Solid Tumours

Zelluna Publishes Compelling Preclinical Data for ZI-MA4-1, the World's First MAGE-A4-Targeting TCR-NK Therapy for Solid Tumours

* Strong preclinical data support planned clinical trial initiation in 2026

Oslo, Norway, 16 December 2025- Zelluna (OSE: ZLNA), a company developing off-

the-shelf cell therapies for cancer, today announced the publication of

preclinical data for its lead candidate, ZI-MA4-1, in the peer-reviewed

journal Immunotherapy Advances*. The data support the company's plan to start

clinical trials in 2026.

The paper describes ZI-MA4-1, a novel cell therapy that combines two powerful

cancer-fighting mechanisms: the precision solid tumour targeting of T cell

receptors (TCRs) with the potent and broad cancer killing ability of Natural

Killer (NK) cells. ZI-MA4-1 targets MAGE-A4, a protein found in many solid

cancers including lung, ovarian, head and neck, and sarcomas.

Key results:

* Kills cancer cells effectively across multiple tumour types

* Works even when tumours try to hide - remains active despite common escape

mechanisms

* Enhanced immune response - triggers multiple anti-cancer mechanisms

* Good safety profile in preclinical studies

Since ZI-MA4-1 is manufactured in advance and stored frozen, it can be given to

patients on demand (off-the-shelf), enabling multiple doses for sustaining a

tumour response and broad patient access.

"This publication validates our approach," said Luise Weigand, Zelluna's Chief

Scientific Officer. "It is also a testament to the dedication and innovation of

our talented team. With our preclinical data completed, manufacturing process

locked, and clinical material ready, we are well-positioned to start clinical

trials in 2026."

Zelluna plans to submit its Clinical Trial Application (CTA) in late 2025, with

first patient data expected mid-2026.

*Read more: Preclinical assessment of MAGE-A4 specific TCR-NK cells against

solid tumors | Immunotherapy Advances | Oxford Academic

(https://academic.oup.com/immunotherapyadv/advance-

article/doi/10.1093/immadv/ltaf036/8380795)

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA

Email: [email protected] (mailto:[email protected])

Phone: +44 7720 687608

International media:

Frazer Hall/Mark Swallow - MEDiSTRAVA

Email: [email protected]

About Zelluna ASA

Zelluna is pioneering allogeneic off-the-shelf T Cell Receptor-based Natural

Killer (TCR-NK) cell therapies for the treatment of solid cancers. 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

in solid tumours. The company's lead candidate, ZI-MA4-1, is the world's first

MAGE-A4-targeting TCR-NK therapy expected to enter clinical trials in 2026.

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.

NORSK VERSJON

Zelluna publiserer overbevisende preklinske data for ZI-MA4-1, verdens første

MAGE-A4-rettede TCR-NK terapi for solide svulster

? Sterke preklinske data støtter planlagt oppstart av klinisk studie i 2026

Oslo, Norge, 16. desember 2025 - Zelluna (OSE: ZLNA), et selskap som utvikler

"off-the-shelf" celleterapi for kreft, kunngjorde i dag publiseringen av

preklinske data for sin hovedkandidat, ZI-MA4-1, i det fagfellevurderte

tidsskriftet Immunotherapy Advances*. Dataene støtter selskapets plan om å

starte kliniske studier i 2026.

Artikkelen beskriver ZI-MA4-1, en ny celleterapi som kombinerer to kraftige

kreftbekjempende mekanismer: T-cellereseptorenes (TCR) presise evne til å

målrette solide svulster sammen med Natural Killer (NK)-cellenes potente og

brede kreftdrepende egenskaper. ZI-MA4-1 målretter MAGE-A4, et protein som

forekommer i mange solide kreftformer som lungekreft, eggstokkreft, hode- og

halskreft, og sarkomer.

Nøkkelresultater:

* Dreper kreftceller effektivt på tvers av flere svulsttyper

* Fungerer selv når svulster prøver å skjule seg - forblir aktiv til tross for

vanlige unndragelsesmekanismer

* Forsterket immunrespons - utløser flere kreftbekjempende mekanismer

* God sikkerhetsprofil i preklinske studier

Siden ZI-MA4-1 produseres på forhånd og lagres frosset, kan den gis til

pasienter ved behov (off-the-shelf), noe som muliggjør flere doser for å

opprettholde en svulstrespons og bred pasienttilgang.

"Denne publiseringen validerer vår tilnærming," sier Luise Weigand, Zellunas

Chief Scientific Officer. "Det er også et vitnesbyrd om dedikasjon og innovasjon

fra vårt talentfulle team. Med våre preklinske data fullført, produksjonsprosess

låst, og klinisk materiale klart, er vi godt posisjonert for å starte kliniske

studier i 2026."

Zelluna planlegger å innlevere sin Clinical Trial Application (CTA) sent i

2025, med første pasientdata forventet medio 2026.

*Les mer: Preclinical assessment of MAGE-A4 specific TCR-NK cells against solid

tumors | Immunotherapy Advances | Oxford Academic

(https://academic.oup.com/immunotherapyadv/advance-

article/doi/10.1093/immadv/ltaf036/8380795)

For ytterligere informasjon, vennligst kontakt:

Namir Hassan, CEO, Zelluna ASA

E-post: [email protected] (mailto:[email protected])

Telefon: +44 7720 687608

Internasjonale media:

Frazer Hall/Mark Swallow - MEDiSTRAVA

E-post: [email protected] (mailto:[email protected])

Om Zelluna ASA

Zelluna er pionér innen allogene "off-the-shelf" T-cellereseptor-baserte Natural

Killer (TCR-NK) celleterapi for behandling av solide kreftformer. Selskapets

plattform kombinerer den medfødte drepende kraften til NK-celler med den presise

målrettingen til TCR-er, designet for å adressere begrensningene ved dagens

celleterapi i solide svulster. Selskapets hovedkandidat, ZI-MA4-1, er verdens

første MAGE-A4-rettede TCR-NK terapi som forventes å gå inn i kliniske studier i

2026. Zelluna har hovedkontor ved Oslo Cancer Cluster Innovation Park i Oslo,

Norge, og er notert på Oslo Børs under ticker ZLNA.

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