- 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
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 for more information.
