This milestone represents a major advancement in the company’s preparation for clinical entry to provide treatments for patients battling cancer, they state. The 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, they state further.

“We are thrilled to have successfully locked down our TCR-NK cell therapy manufacturing process,” says 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 tumors and improve patient outcomes. This accomplishment is a testament to the exceptional talent and relentless drive of our team and partners.”

Preparation for Clinical Entry

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, states the company.

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 tumors, they state.

Zelluna has partnered with CDMO Catalent for process development and manufacturing.

Its first TCR-NK cell therapy product

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 tumors, with high standards of purity, potency, and safety, designed to meet the needs of patients while also adhering to the latest regulatory requirements, describes the company.