Oslo, Norway, 22 April 2025 - Zelluna (OSE: ZLNA), a company pioneering
allogeneic 'off the shelf' T Cell Receptor based Natural Killer (TCR-NK) cells
for the treatment of cancer, has successfully developed, scaled and automated
its proprietary manufacturing process for its TCR-NK cell therapies. This
milestone represents a major advancement in the Company's preparation for
clinical entry to provide life-changing, innovative treatments for patients
battling cancer. The proprietary manufacturing process is applicable to any
product emerging from the Company's pipeline which means any TCR-NK product can
be plugged into the established manufacturing process strengthening Zelluna's
dominance of the TCR-NK therapeutic field.
Establishing and locking down a manufacturing process marks an essential step
towards the production of TCR-NK cell therapies for clinical development and
future commercialization. Based on the established manufacturing process,
hundreds of doses could be produced from a single manufacturing batch
highlighting scalability and low cost of goods potential. Zelluna continues to
advance its lead TCR-NK cell therapy candidate ZI-MA4-1 in preparation for a
filing in the second half of 2025 to begin clinical development targeting a
variety of solid tumours.
Zelluna has partnered with Catalent, a leading global contract development and
manufacturing organization (CDMO), for process development and manufacturing.
Catalent brings significant experience in cell therapy manufacturing in
compliance with the highest quality standards.
Emilie Gauthy, Head of CMC at Zelluna, commented: "Today marks an important
milestone for Zelluna and a crucial step in the development of our novel off the
shelf TCR-NK therapies, giving us the potential to make them widely accessible
for patients. For any cell therapy, the complexities and challenges of
manufacturing are well known and so establishing an efficient process represents
a significant achievement. I am therefore incredibly proud of what our team
together with our CDMO partners have achieved in transforming a groundbreaking
concept from the laboratory into a tangible lead product ready for clinical
development that can potentially benefit a wide cross-section of cancer
patients."
The established process has delivered its first TCR-NK cell therapy product in
the form of Zelluna's lead asset ZI-MA4-1 targeted at solid tumours, with high
standards of purity, potency, and safety, designed to meet the needs of patients
while also adhering to the latest regulatory requirements. ZI-MA4-1 has shown
promising results in preclinical studies, demonstrating the potential of TCR-NK
cells to effectively target and eliminate diverse cancer types, in ways that can
overcome cancer escape, and with an anticipated favorable safety profile
compared to benchmarked cell-based immunotherapies. The company is now well-
positioned to move forward with clinical trials and bring this groundbreaking
therapy closer to patients.
"We are thrilled to have successfully locked down our TCR-NK cell therapy
manufacturing process," said Namir Hassan, CEO of Zelluna. "This pivotal
achievement not only demonstrates our capability to produce high-quality,
scalable TCR-NK cell therapies, but also underscores our commitment to advancing
next-generation immunotherapies that could transform the treatment of solid
tumours and improve patient outcomes. This accomplishment is a testament to the
exceptional talent and relentless drive of our team and partners."
For further information, please contact:
Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com (mailto:namir.hassan@zelluna.com)
Phone: +44 7720 687608
Hans Vassgård Eid, CFO, Zelluna ASA
Email: hans.eid@zelluna.com (mailto:[%20hans.eid@zelluna.com])
Phone: +47 482 48632
About Zelluna ASA
Zelluna's mission is to deliver transformative treatments with the capacity to
cure advanced solid cancers, in a safe and cost-efficient manner, to patients on
a global scale. The Company aims to do this by combining the most powerful
elements of the immune system through pioneering the development of "off the
shelf" T cell receptor (TCR) guided natural killer (NK) cell therapies (TCR-NK).
The TCR-NK platform offers a unique mechanism of action with broad cancer
detection capability to overcome the diversity of tumours and will be used "off
the shelf" to overcome scaling limitations of current cell therapies. The lead
program is a world's first MAGE-A4 targeting "off the shelf" TCR-NK for the
treatment of various solid cancers; a pipeline of earlier products follows. The
Company is led by a management team of biotech entrepreneurs with deep
experience in discovery through to clinical development of TCR and cell-based
therapies including marketed products.
For more information, please visit www.zelluna.com
(https://eur02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.zelluna.co
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This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Hans Vassgård Eid, CFO of
Zelluna ASA, on 22 April 2025 at 07.45 CET.