The CMDO VIVEbiotech and Zelluna have announced a new partnership to manufacture lentiviral vectors for the development of TCR-NK therapies targeting solid tumours of high unmet medical need.
Patient access to autologous CAR-T therapies has so far been limited due to the complex and personalised manufacturing process.
Offering an off-the-shelf approach in which a single batch can be made upfront would be a "game changer," delivering hundreds of doses stored frozen, ready for immediate use and allowing access to larger patient populations.
Additionally the performance of the viral vector used to engineer primary cells is an important contributing factor, with Zelluna stating that VIVEbiotech's proven expertise in lentiviral vector technologies made it the partner of choice for pioneering the development of the new process.
The partnership will leverage VIVEbiotech's well-established manufacturing platform, which has supported collaborations with more than 55 clients across the US, Europe, Asia and Australia, for both ex vivo and in vivo advanced therapies.
The collaboration between VIVEbiotech and Zelluna has been ongoing since 2018, with Zelluna recently announcing the establishment of its proprietary manufacturing process and its lead programme, ZI-MA4-1, a novel TCR-NK therapy targeting the MAGE-A4 tumour antigen, planned to enter clinical trials in 2026.
"This collaboration with Zelluna exemplifies our commitment to enabling the next generation of cell therapies through high-quality, scalable lentiviral vector manufacturing," said Jon Alberdi, CEO of VIVEbiotech.
By combining our deep expertise in GMP vector production with Zelluna’s pioneering TCR-NK platform, we are proud to contribute to the advancement of innovative therapies that hold immense promise for patients with solid tumours.
Emilie Gauthy, CTO at Zelluna, added: "The collaboration with VIVEbiotech has contributed meaningfully to the development of our novel off-the-shelf TCR-NK therapies, enabling the manufacture of vectors essential for the successful delivery of DNA cargo in the generation of our ZI-MA4-1 lead product."
I am truly pleased with our partnership with VIVEbiotech, which has proven to be a reliable and supportive ally in transforming a groundbreaking concept into a tangible product, ready for clinical development and with the potential to benefit a broad range of cancer patients.