Syena Begins Phase 1/2 Clinical Trial with First Patient Treated for Multiple Myeloma Using TCR-NK Cell Therapy

Syena, a subsidiary of Replay specializing in cell therapy, has initiated a Phase 1/2 clinical trial for patients with multiple myeloma. The trial involves the use of engineered T-Cell Receptor Natural Killer (TCR-NK) cells, which target the NY-ESO-1 antigen, a protein overexpressed in various cancer types. The treatment, NY-ESO-1 TCR/IL-15 NK, is based on the research of Professor Katy Rezvani from MD Anderson Cancer Center and is developed under an exclusive license from MD Anderson to Syena. The study will evaluate the safety and potential effectiveness of this novel cell therapy in up to 44 patients who have not responded to standard treatments.
The therapy is made from cord blood-derived NK cells that have been modified to express a receptor with enhanced affinity for the NY-ESO-1 antigen. This approach is considered groundbreaking due to the antigen's immunogenic properties and its presence on a wide range of cancer cells, making it an ideal target for immunotherapy.
Replay's leadership, including Adrian Woolfson and Lachlan MacKinnon, have expressed optimism about the potential of this therapy to fulfill the urgent medical need for readily available cell treatments. They highlighted the rapid progress of the clinical study and the significance of the NY-ESO-1 antigen in treating multiple myeloma with poor prognosis.
The clinical trial is registered on ClinicalTrials.gov with the identifier NCT06066359 for further details. Replay, which is headquartered in San Diego, California, is a genomic medicine company focused on advancing the field through innovative DNA technologies. The company has developed a high-capacity delivery platform and has established a business model that separates technology development from therapeutic applications across various product companies.
Replay has successfully raised $85 million in funding and is backed by a consortium of investors, including KKR, OMX Ventures, ARTIS Ventures, Lansdowne Partners, and the Bill and Melinda Gates Foundation. The company's mission is to redefine genomic medicine by overcoming current limitations and unlocking its full potential.

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