* Global CRO to support execution of ZIMA-101 study with world's first MAGE-
A4-targeting TCR-NK cell therapy product
* Partnership follows submission of the Clinical Trial Application (CTA) to
the MHRA
Oslo, Norway - 11 February 2026 - Zelluna (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 a clinical
partnership with Medpace, a leading global Contract Research Organization (CRO),
to support the first clinical trial of ZI-MA4-1 (ZIMA-101), Zelluna's lead
product candidate.
Highlights:
* Medpace selected as clinical partner for ZI-MA4-1 (ZIMA-101) first-in-human
Phase 1 study
* Comprehensive CRO services to support Zelluna's transition to clinical-stage
company
* Study to evaluate safety and early efficacy in patients with advanced solid
cancers
* Clinical data expected to emerge from mid-2026
* Marks first clinical evaluation of Zelluna's proprietary TCR-NK platform
The partnership with Medpace marks a critical step in Zelluna's transition from
preclinical to clinical stage. Medpace will provide comprehensive clinical
development services including clinical operations and trial management,
regulatory support, data management and analysis, as well as pharmacovigilance.
This gives Zelluna access to experienced infrastructure and expertise necessary
to execute a complex cell therapy trial in accordance with international
standards.
ZI-MA4-1 is a novel cell therapy that combines two powerful mechanisms to fight
cancer: precise tumour recognition via T cell receptors (TCRs) that identify
MAGE-A4, a protein found in many solid cancers, and broad and potent killing
ability from Natural Killer (NK) cells that can eliminate cancer cells through
multiple pathways simultaneously.
The planned Phase 1 study will evaluate safety, tolerability, and early signs of
clinical activity in patients with advanced solid cancers including lung cancer,
ovarian cancer, head and neck cancer, and sarcomas. The study represents the
first clinical validation of Zelluna's proprietary TCR-NK platform, and initial
clinical data is expected to emerge from mid-2026.
"Selecting Medpace as our clinical partner reflects a deliberate and strategic
choice as we transition into clinical stage," said Namir Hassan, CEO of Zelluna.
"Medpace brings deep oncology expertise and a strong track record in early-phase
development, including cell therapies. This first study will not only advance
ZI-MA4-1, but also provide us with clinical insights into the broader potential
of our TCR-NK platform."
"Zelluna's TCR-NK platform represents a novel and innovative approach to
addressing key challenges in cell therapy for solid tumors," said Lyon Gleich,
MD, Senior Vice President, Medical Department at Medpace. "We look forward to
partnering with the Zelluna team to support the efficient and rigorous execution
of the ZI-MA4-1 first-in-human study."
Zelluna plans to initiate the first clinical trial of ZI-MA4-1 subject to
regulatory approval (CTA approval), marking a key milestone in the clinical
development of the company's off-the-shelf TCR-NK cell therapy portfolio.
About Zelluna ASA
Zelluna ASA (OSE: ZLNA) is pioneering allogeneic "off-the-shelf" T Cell
Receptor-based Natural Killer (TCR-NK) cell therapies for solid cancers. The
company's lead candidate, ZI-MA4-1, is the world's first MAGE-A4 targeting TCR-
NK therapy. Zelluna submitted its Clinical Trial Application to the UK MHRA in
December 2025, with initial clinical data expected to emerge from mid-2026.
Zelluna is headquartered in Oslo, Norway, and is listed on the Oslo Stock
Exchange under the ticker ZLNA.
For further information, please contact:
Namir Hassan, CEO, Zelluna ASA
Email: Namir.hassan@zelluna.com (mailto:Namir.hassan@zelluna.com)
Phone: +44 7720 687608
About Medpace
Medpace is a scientifically-driven, global, full-service clinical contract
research organization (CRO) providing Phase I-IV clinical development services
to the biotechnology, pharmaceutical and medical device industries. Medpace's
mission is to accelerate the global development of safe and effective medical
therapeutics through its high-science and disciplined operating approach that
leverages regulatory and therapeutic expertise across all major areas including
oncology, cardiology, metabolic disease, endocrinology, central nervous system
and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace
employs approximately 6,200 people across 44 countries as of September
30, 2025. Visit Medpace.com (https://www.medpace.com/) for more information.