Zelluna Launches Human Trial for Novel Solid Cancer Cell Therapy

OSLO, Norway – February 11, 2026 – Norwegian biotechnology firm Zelluna has announced a pivotal step in its quest to treat solid cancers, selecting global research organization Medpace to conduct the first-in-human clinical trial for its lead candidate, ZIMA-101. The move signals Zelluna's transition from a preclinical research company to a clinical-stage entity, bringing its pioneering cell therapy one step closer to patients.

The upcoming Phase 1 study will evaluate ZIMA-101, the world's first T Cell Receptor-based Natural Killer (TCR-NK) cell therapy designed to target the MAGE-A4 antigen, a protein prevalent in a range of difficult-to-treat solid tumors. This partnership marks a critical milestone not only for Zelluna but also for the broader field of oncology, which has long sought effective cell-based treatments for solid malignancies.

A New Strategy for Solid Tumors

For years, the remarkable success of cell therapies like CAR-T in treating blood cancers has not translated effectively to solid tumors. These dense, complex masses create a hostile tumor microenvironment (TME) that can suppress and evade immune attacks, limiting the efficacy of engineered T-cells. Zelluna’s TCR-NK platform represents a novel strategy engineered to overcome these hurdles.

ZIMA-101 combines two of the immune system's most powerful components into a single, dual-action therapeutic. It uses a T-cell receptor (TCR) for its precision, acting like a highly specific GPS to guide the therapy directly to cancer cells expressing the MAGE-A4 protein. Once targeted, the therapy unleashes the broad and potent killing ability of Natural Killer (NK) cells, which can destroy cancerous cells through multiple pathways simultaneously. This approach is designed to be more resilient within the challenging TME.

A key advantage of Zelluna's platform is its allogeneic, or "off-the-shelf," nature. Unlike autologous therapies that are manufactured on a per-patient basis using their own cells—a costly and time-consuming process—ZIMA-101 is developed from healthy, pre-screened donors. This allows for the creation of a standardized, readily available treatment that can be administered to multiple patients, potentially reducing costs and wait times significantly.

The MAGE-A4 Target

The effectiveness of any targeted therapy hinges on the quality of its target. Zelluna's choice of MAGE-A4 is highly strategic. MAGE-A4 is a cancer-testis antigen, meaning its expression is largely restricted to tumor cells and immune-privileged sites in healthy adults, minimizing the risk of the therapy attacking healthy tissue.

Research has shown that MAGE-A4 is present in a significant percentage of solid tumors with high unmet medical need. Studies indicate notable prevalence in head and neck squamous cell carcinoma (60%), squamous non-small cell lung cancer (64%), ovarian cancer (64%), and various sarcomas, including synovial sarcoma (70%). The Phase 1 trial for ZIMA-101 will specifically recruit patients with these types of advanced cancers, directly addressing the populations most likely to benefit.

By focusing on such a prevalent and specific target, Zelluna aims to provide a new therapeutic option for a broad group of cancer patients who may have exhausted other treatments.

A Strategic Leap into the Clinic

Transitioning a novel therapy from the laboratory to human trials is a monumental undertaking fraught with operational and regulatory complexities. Zelluna's partnership with Medpace, a leading Contract Research Organization (CRO), is a deliberate move to de-risk this process. Medpace will provide a comprehensive suite of services, including clinical trial management, regulatory support, and data analysis, leveraging its deep expertise in both oncology and advanced cell therapies.

"Selecting Medpace as our clinical partner reflects a deliberate and strategic choice as we transition into clinical stage," said Namir Hassan, CEO of Zelluna, in a statement. "Medpace brings deep oncology expertise and a strong track record in early-phase development, including cell therapies."

This collaboration follows Zelluna's submission of a Clinical Trial Application (CTA) to the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in December 2025. Subject to regulatory approval, the trial will begin, with initial data on safety and preliminary efficacy expected to emerge by mid-2026.

Lyon Gleich, MD, Senior Vice President at Medpace, commented on the partnership, stating, "Zelluna's TCR-NK platform represents a novel and innovative approach to addressing key challenges in cell therapy for solid tumors. 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."

Navigating a Competitive, High-Stakes Field

Zelluna is entering a dynamic and competitive landscape. Other companies, such as Adaptimmune, are also developing therapies targeting MAGE-A4, though with different technologies like engineered T-cells. Zelluna's unique TCR-NK approach, however, sets it apart and positions it as a pioneer in this specific modality.

The initiation of this trial is backed by a recent capital raise of NOK 58.2 million in late 2025, which extended the company's financial runway into early 2027. This funding is critical to support the high costs associated with advanced clinical development. The results of the Phase 1 trial will be a crucial value inflection point for the company, heavily influencing future investment and strategic partnerships.

For the broader oncology community, the ZIMA-101 trial will be a closely watched event. Its success or failure will provide invaluable clinical insights into the potential of the TCR-NK platform and could pave the way for a new class of accessible, off-the-shelf cell therapies for solid cancers. The journey for ZIMA-101 is just beginning, but for patients with advanced solid cancers, it represents a new beacon of hope on the therapeutic horizon.