Zelluna Submits Clinical Trial Application to UK MHRA for First-in-Human TCR-NK Cell Therapy

(AWP Alliance News) - Zelluna ASA has submitted a Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its lead candidate, ZI-MA4-1 (ZIMA-101), marking a significant regulatory milestone. This submission allows Zelluna to transition from preclinical to clinical development for the world's first MAGE-A4-targeting TCR-NK cell therapy for solid tumours. The application follows the completion of key 2025 milestones, including t…

Zelluna har nådd en viktig milepæl og innleverer søknad om klinisk studie i Storbritannia for første studie på mennesker av ZI-MA4-1 (ZIMA-101), verdens første MAGE-A4-rettede TCR-NK celleterapi for solide kreftformer.

Forventer første kliniske data fra midten av 2026 Markerer et viktig skritt mot skalerbare, tilgjengelige "off-the-shelf" celleterapier for solide kreftformer Produksjonsprosess etablert (april 2025) Preklinisk datapakke fullført og nøkkeldata publisert (desember 2025) GMP-klinisk batch produsert og kvalitetstestet (desember 2025) Søknad om klinisk studie innlevert til britiske MHRA (desember 2025) Oslo, Norge, 17. desember 2025 – Zelluna (OSE: ZLNA), et bioteknologiselskap s…

Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours

On track for initial clinical data in mid-2026 Marks a pivotal step toward scalable, accessible, off-the-shelf cell therapies for solid tumours Manufacturing process locked (April 2025) Preclinical data package completed and key data published (December 2025) GMP clinical batch produced and quality-tested (December 2025) Clinical Trial Application submitted to the UK MHRA (December 2025) Oslo, Norway, 17 December 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic off…

ZLNA: 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 2026Oslo, Norway, 16 December 2025- Zelluna (OSE: ZLNA), a company developing off-the-shelf cell therapies for cancer, today announced the publication ofpreclinical data for its lead candidate, ZI-MA4-1, in the peer-reviewedjournal Immunotherapy Advances*. The data support the company's plan to startclinical trials in 2026.The paper describes ZI-MA4-1, a novel cell therapy that combines two powerfulcancer-…

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 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 Dreper kreftceller effektivt på tvers av flere svulsttyper Fungerer selv når svulster prøver å skjule seg – forblir aktiv til tross for vanlige unndr…

BioStock: Zelluna: killer cells tackling the solid cancer bottleneck

Norwegian biotech company Zelluna is rapidly advancing its "off-the-shelf" TCR-NK cell therapies towards clinical development. Following a transformative merger earlier this year, the company has secured positive regulatory feedback from the UK’s MHRA and initiated GMP manufacturing with Catalent. With a cash runway extending into 2027, Zelluna is now fully focused on launching its first-in-human trial with lead candidate ZI-MA4-1. BioStock contacted CEO Namir Hassan …

Zelluna Produces First GMP Batch of Novel TCR-NK Cell Therapy for Solid Tumors

(AWP Alliance News) - Zelluna ASA has announced the successful manufacture and quality control testing of the first GMP batch of its lead candidate, ZI-MA4-1, a novel TCR-NK cell therapy targeting MAGE-A4 for the treatment of solid tumors. The company confirmed that this material will be used in its upcoming first-in-human clinical trial, with a Clinical Trial Application (CTA) submission planned for the second half of 2025 and initial clinical data expected by mid-2026. The …

Zelluna Completes First GMP Batch of ZI-MA4-1, a Novel TCR-NK Cell Therapy, to Treat Patients in Upcoming First-in-Human Trial

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…

Zelluna ASA Cancels Subsequent Offering After Private Placement

(AWP Alliance News) - Zelluna ASA announced that following its recent private placement, the company's board has decided not to proceed with a planned subsequent repair offering. The decision was made after the company's shares traded at or below the subscription price of the private placement for an extended period and in sufficient volumes, allowing shareholders the opportunity to acquire shares at or below the intended subscription price of the subsequent offering. https:/…

Zelluna ASA: Cancellation of subsequent repair offering

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. Oslo, 9 December, 2025: Reference is made to the stock exchange announcement published by Zelluna ASA ("Zelluna" or the "Company") on 3 November 2025 regarding the private placement (the "Private Placement"), and the intention to carry out a subsequent repair off…

Zelluna ASA publishes update to their financial calendar

(AWP Alliance News) - Zelluna ASA will publish its Annual Report for 2025 on March 25, 2026. The company's Annual General Meeting for 2025 is scheduled for April 23, 2026. Zelluna ASA will release its Q4 2025 Quarterly Report on February 12, 2026. The Q1 2026 Quarterly Report will be published on May 7, 2026. The Half-yearly Report for 2026 will be released on August 20, 2026. The Q3 2026 Quarterly Report is scheduled for November 5, 2026. Zelluna ASA will publish its Q4 2026…

ZLNA: Financial calendar

Financial calendar for Zelluna ASAFINANCIAL YEAR 202525.03.2026 - Annual Report23.04.2026 - Annual General Meeting12.02.2026 - Quarterly Report - Q4FINANCIAL YEAR 202620.08.2026 - Half-yearly Report31.03.2027 - Annual Report29.04.2027 - Annual General Meeting07.05.2026 - Quarterly Report - Q105.11.2026 - Quarterly Report - Q311.02.2027 - Quarterly Report - Q4This information is published pursuant to the requirements set out in theContinuing obligations.

Zelluna ASA Announces Private Placement and Retail Share Offering

(AWP Alliance News) - Zelluna ASA has announced a private placement and a retail offering through PrimaryBid. The company referenced the facilitation of settlement for listed shares in tranche 2 of the private placement, with a PDMR form attached regarding share lending activities related to the transaction. https://www.globenewswire.com/NewsRoom/ReleaseNg/402280025 Disclaimer: This news brief was created using generative artificial intelligence. Zelluna ASA published the ori…

Zelluna ASA - Mandatory notification of trade

Reference is made to the private placement (the "Private Placement") and theretail offering through PrimaryBid announced by Zelluna ASA on 3 November 2025.Please see the attached PDMR-form related to share lending to facilitatesettlement of listed shares in tranche 2 of the Private Placement.

Zelluna ASA - Mandatory notification of trade

Reference is made to the private placement (the "Private Placement") and the retail offering through PrimaryBid announced by Zelluna ASA on 3 November 2025. Please see the attached PDMR-form related to share lending to facilitate settlement of listed shares in tranche 2 of the Private Placement. Attachment PDMR attachment

Zelluna ASA Completes Private Placement of 5.5 Million New Shares

(AWP Alliance News) - Zelluna ASA has completed a private placement, issuing a total of 5,500,000 new shares. The placement was divided into two tranches: 3,729,774 shares in the first tranche and 1,770,226 shares in the second tranche. Additionally, 315,639 new shares were allocated in a retail offering via the PrimaryBid platform. The increase in share capital for the second tranche has now been registered, bringing Zelluna ASA's total share capital to NOK 26,269,801, divid…

Zelluna ASA: New share capital registered

Oslo, Norway, 8 December, 2025: Reference is made to the stock exchange announcement made by Zelluna ASA (the "Company") on 3 November 2025 regarding the successful private placement of 5,500,000 new shares (the "Private Placement"), divided on a first tranche of 3,729,774 new shares and a second tranche of 1,770,226 new shares ("Tranche 2"), and the allocation of 315,639 new shares in the retail offering carried out via the PrimaryBid platform. The share capital increase per…

Norway's Zelluna Names New Finance Chief

02:40 AM EST, 11/28/2025 (MT Newswires) -- Zelluna (ZLNA.OL) named Geir Christian Melen as its new chief financial officer, effective Jan. 1, 2026. Melen is set to succeed Hans Vassgård Eid, who will step down at the end of December, the Norwegian biopharmaceutical company said Friday.

Zelluna ASA Names Geir Christian Melen as New CFO

(AWP Alliance News) - Zelluna ASA has appointed Geir Christian Melen as its new Chief Financial Officer, effective January 1, 2026. Hans Vassgård Eid will step down as CFO at the end of December 2025 and assist with the transition. https://www.globenewswire.com/NewsRoom/ReleaseNg/402273146 Disclaimer: This news brief was created using generative artificial intelligence. Zelluna ASA published the original content used to generate this news brief via GlobeNewswire on November 2…

Zelluna ASA Announces Appointment of Geir Christian Melen as New Chief Financial Officer

Oslo, Norway, 28 November 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 appointment of Geir Christian Melen as new Chief Financial Officer, effective 01 January 2026. Hans Vassgård Eid will be stepping down as CFO of Zelluna ASA from the end of December 2025 and supporting the transition thereafter. “I am very pleased to appoint Geir Chri…

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